Clinical Trial Results:
A phase III/IV, cluster-randomized, controlled study to evaluate the effectiveness of GlaxoSmithKline Biologicals’ 10-valent pneumococcal and non-typeable Haemophilus influenzae protein D conjugate vaccine in reducing the incidence of invasive diseases.
Summary
|
|
EudraCT number |
2008-005149-48 |
Trial protocol |
FI |
Global end of trial date |
05 Oct 2013
|
Results information
|
|
Results version number |
v3 |
This version publication date |
15 Nov 2020
|
First version publication date |
29 Jul 2015
|
Other versions |
v1 , v2 , v4 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
111442
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00861380 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical Disclosure Advisor,, GlaxoSmithKline Biologicals,, 044 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
GSK Response Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
|
||
EMA paediatric investigation plan number(s) |
EMEA-000673-PIP01-09 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
15 Jan 2019
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
05 Oct 2013
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To demonstrate the effectiveness of 10Pn-PD-DiT vaccine in preventing culture-confirmed IPD due to vaccine pneumococcal serotypes in children vaccinated with at least one dose of 10Pn-PD-DiT within the first 7 months of life in clusters assigned to a 3-dose primary vaccination course.
Criteria for effectiveness: Effectiveness (VE) in preventing culture-confirmed IPD due to the 10 vaccine serotypes will be demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = {vaccine-type [VT] IPD VE = 0%} is lower than 5%.
|
||
Protection of trial subjects |
The nurses administering vaccines were instructed to observe the vaccinees closely for at least 30
minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed up for serious adverse events (SAEs) reported as occurring during the study up to study end. In addition, an Independent Data Monitoring Committee (IDMC) was set up, of which responsibilities included the following: (1) Review of data collection methods, safety/effectiveness monitoring procedures and making recommendations for additions or adjustments, as applicable; (2) Recommendations for maintaining, or breaking the blind where necessary, in the course of reviewing safety results; (3) Recommendations for stopping the trial for effectiveness or safety reasons when appropriate.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 May 2009
|
||
Long term follow-up planned |
Yes
|
||
Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
18 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Finland: 87165
|
||
Worldwide total number of subjects |
87165
|
||
EEA total number of subjects |
87165
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
87165
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment details |
This study also served as basis for conducting a long-term evaluation of the impact of vaccination with GSK Biologicals’ 10Pn-PD-DiT vaccine. 4796 subjects of the 10PN-PD-DIT-053 (112595) study (NCT00839254-EUDRACT:2008-006551-51) contributed to objectives of this study i.e.: a total of 45977 subjects. | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||
Screening details |
41188 subjects were enrolled in 10PN-PD-DIT-043 study, 7 subjects didn't receive any vaccination, 41181 subjects started in the study. | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment period milestones
|
|||||||||||||||||||||||||||||||||||||||||
Number of subjects started |
87165 | ||||||||||||||||||||||||||||||||||||||||
Number of subjects completed |
41181 | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment subject non-completion reasons
|
|||||||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
10PN043-053 subjects: 45977 | ||||||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
10PN-043 Subjects not vaccinated: 7 | ||||||||||||||||||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
10Pn3+1-6W-6M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
10-valent pneumococcal and non-typeable H. influenzae
protein D conjugate vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
10Pn-PD-DiT
|
||||||||||||||||||||||||||||||||||||||||
Other name |
10Pn, Synflorix
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
10Pn2+1-6W-6M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
10-valent pneumococcal and non-typeable H. influenzae
protein D conjugate vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
10Pn-PD-DiT
|
||||||||||||||||||||||||||||||||||||||||
Other name |
10Pn, Synflorix
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
Ctrl-6W-6M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Engerix B-thio free
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
Engerix-B,HBV
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
10Pn7-11M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
10-valent pneumococcal and non-typeable H. influenzae
protein D conjugate vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
10Pn-PD-DiT
|
||||||||||||||||||||||||||||||||||||||||
Other name |
10Pn, Synflorix
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
Ctrl7-11M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Engerix B-thio free
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
Engerix-B,HBV
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
10Pn12-18M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
10-valent pneumococcal and non-typeable H. influenzae
protein D conjugate vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
10Pn-PD-DiT
|
||||||||||||||||||||||||||||||||||||||||
Other name |
10Pn, Synflorix
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh or in the deltoid region of upper arm, provided
the muscle size was adequate.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
Ctrl12-18M/043 Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Havrix-preservative free
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
HAV, Havrix 720 Junior
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Intramuscularly administration by injection in the thigh or in the deltoid region of upper arm, provided
the muscle size was adequate.
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 4796 subjects of the 10PN-PD-DIT-053 (112595) study (NCT00839254-EUDRACT:2008-006551-51) contributed to objectives of this study i.e.: a total of 45977 subjects were part of objective analysis for both studies. 41188 subjects were planned to be vaccinated in the study. 41181 of these were actually vaccinated and included in baseline period of the study. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn3+1-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn2+1-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn7-11M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl7-11M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn12-18M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl12-18M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
10Pn3+1-6W-6M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||
Reporting group title |
10Pn2+1-6W-6M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||
Reporting group title |
Ctrl-6W-6M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||
Reporting group title |
10Pn7-11M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||
Reporting group title |
Ctrl7-11M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||
Reporting group title |
10Pn12-18M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||
Reporting group title |
Ctrl12-18M/043 Group
|
||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||
Subject analysis set title |
10Pn3+1-6W-6M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1846 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). Refer to group description for 10Pn3+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
Ctrl-6W-6M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 1329 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for Ctrl6W-6M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
10Pn2+1-6W-6M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 942 subjects) studies, pooled, and aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). Refer to group description for 10Pn2+1-6W-6M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
10Pn7-11M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 191 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for 10Pn7-11M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
Ctrl7-11M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 96 subjects) studies, pooled, and aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). Refer to group description for Ctrl7-11M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
10Pn12-18M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 286 subjects) studies, pooled, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for 10Pn12-18M/043 Group for vaccine specifics and administration route in this group.
|
||
Subject analysis set title |
Ctrl12-18M/043+053 Group
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects analyzed among all subjects who were enrolled in this group in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) and 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) (i.e. 106 subjects) studies, pooled, and aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). Refer to group description for Ctrl12-18M/043 Group for vaccine specifics and administration route in this group.
|
|
|||||||||||||
End point title |
Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | ||||||||||||
End point description |
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 =(vaccine-type [VT] IPD VE = 0%) was lower than (<) 5%.
|
||||||||||||
Comparison groups |
Ctrl-6W-6M/043+053 Group v 10Pn3+1-6W-6M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
20474
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[1] | ||||||||||||
P-value |
< 0.0001 [2] | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Parameter type |
VE (1-RR) | ||||||||||||
Point estimate |
100
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
82.8 | ||||||||||||
upper limit |
100 | ||||||||||||
Notes [1] - VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN3+1 vs Control). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect. [2] - P-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints. |
|
|||||||||||||
End point title |
Person Year Rate as regards subjects with culture-confirmed IPD due to any of the 10 pneumococcal vaccine serotypes. In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | ||||||||||||
End point description |
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
Analysis aimed at providing an estimate of vaccine effectiveness (VE) at preventing culture-confirmed IPD by comparing PYARs between groups taking into account the following parameters: T, n, n+ (number of clusters with at least one event culture-confirmed ID), and n/T. VE of the 10Pn vaccine in preventing culture-confirmed IPD due to the 10 vaccine serotypes was demonstrated if the 2-sided p-value calculated for the null hypothesis H0 = (vaccine-type [VT] IPD VE = 0%) was lower than (<) 5%.
|
||||||||||||
Comparison groups |
10Pn2+1-6W-6M/043+053 Group v Ctrl-6W-6M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
20255
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[3] | ||||||||||||
P-value |
= 0.0009 [4] | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Parameter type |
VE (1-RR) | ||||||||||||
Point estimate |
91.8
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
58.3 | ||||||||||||
upper limit |
99.6 | ||||||||||||
Notes [3] - VE (defined as 1 minus Relative Risk (RR)) was calculated by comparing numbers of culture-confirmed IPD. The number of subjects with IPD in each cluster was compared between groups (10PN2+1vsControl). This comparison was done using a negative binomial log-linear model with correction for dispersion group- and cluster- related effect. [4] - p-value was calculated using a classical log linear Poisson regression with strata, without taking into account the multiplicity of the endpoints. |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course (till end of blinded ID FU period) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course (till end of blinded ID FU period) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Person Year Rate in the prevention of culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log- likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 1 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[5] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
14.657
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
13.229 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
16.197 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [5] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[6] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
13.582
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
11.691 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
15.693 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [6] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[7] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
8.452
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
7.376 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
9.639 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [7] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[8] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
7.603
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
6.206 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
9.221 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [8] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 5 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[9] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
1.637
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
1.185 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
2.205 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [9] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 2626735. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 6 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[10] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
1.845
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
1.194 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
2.724 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [10] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons = 1354702. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 7 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[11] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
3.997
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
3.269 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
4.839 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [11] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as . 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 2626735. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 8 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[12] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
3.322
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
2.423 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
4.445 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [12] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons = 1354702. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 9 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[13] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
14.487
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
13.071 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
16.015 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [13] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 10 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[14] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
13.74
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
11.841 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
15.857 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [14] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 11 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[15] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
7.813
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
6.782 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
8.955 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [15] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 12 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[16] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
7.789
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
6.377 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
9.42 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [16] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 13 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[17] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
2.313
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
1.77 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
2.972 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [17] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 14 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[18] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
1.984
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
1.307 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
2.886 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [18] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 15 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[19] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model without strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
4.172
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
3.429 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
5.028 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [19] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =2636783. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 16 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[20] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model without strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
3.968
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
2.981 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
5.177 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [20] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model without strata). Total number of non-vaccinated persons =1360966. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 17 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[21] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
14.017
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
12.628 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
15.516 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [21] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 18 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (any serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[22] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
15.066
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
13.079 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
17.269 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [22] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 19 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[23] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
5.916
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
5.026 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
6.917 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [23] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 20 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine serotype), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[24] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
8.557
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
7.077 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
10.255 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [24] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 21 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[25] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
2.977
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
2.357 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
3.71 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [25] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =2654010. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 22 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[26] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Regression, Linear | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
2.048
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
1.361 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
2.96 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [26] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata). Total number of non-vaccinated persons =1367343. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 23 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[27] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
5.011
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
4.196 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
5.939 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [27] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 24 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Culture-confirmed IPD (non-vaccine & non-vaccine related), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Number of subjects included in analysis |
9661
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Analysis type |
[28] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Method |
Negative Binomial model with strata | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Parameter type |
PYAR | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Point estimate |
4.315
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
level |
95% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
lower limit |
3.285 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
upper limit |
5.566 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [28] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a culture confirmed IPD divided by sum of follow-up period expressed in years (per 100000), as well as the 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343. |
|
|||||||||||||||||||
End point title |
Person Year Rate in the prevention of probable culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | ||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | ||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 7-11 months schedule | ||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in the prevention of probable or culture-confirmed invasive disease (ID)- In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population) | ||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata. Data were not collected regarding indirect effects.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | ||||||||||||
End point description |
PYAR was calculated: n (=number of subjects with hospital-diagnosed pneumonia) divided by T (=sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia- In children starting vaccination in the 7-11 months schedule | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population) | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[29] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
9.218
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
9.103 | ||||||||||||
upper limit |
9.335 | ||||||||||||
Notes [29] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2626735. |
|||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[30] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
9.212
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
9.052 | ||||||||||||
upper limit |
9.375 | ||||||||||||
Notes [30] - In 5 to 99+ Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1354702. |
|||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[31] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
10.5
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
10.378 | ||||||||||||
upper limit |
10.624 | ||||||||||||
Notes [31] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2636783. |
|||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[32] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
10.429
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
10.259 | ||||||||||||
upper limit |
10.601 | ||||||||||||
Notes [32] - In 5 to 99+ Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1360966. |
|||||||||||||
Statistical analysis title |
Statistical analysis 5 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[33] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
10.118
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
9.997 | ||||||||||||
upper limit |
10.239 | ||||||||||||
Notes [33] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =2654010. |
|||||||||||||
Statistical analysis title |
Statistical analysis 6 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Hospital-diagnosed Pneumonia, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[34] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
9.921
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
9.755 | ||||||||||||
upper limit |
10.088 | ||||||||||||
Notes [34] - In 5 to 99+ Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with a Hospital-diagnosed Pneumonia divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =1367343. |
|
||||||||||||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia with Chest X-ray (CXR) reading according to WHO criteria- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | |||||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | |||||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 7-11 months schedule | |||||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Person Year Rate in reducing hospital-diagnosed pneumonia with CXR reading according to WHO criteria - In children starting vaccination in the 12-18 months schedule | |||||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in prevention of all tympanostomy tube placements- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was
considered if at least 30-day interval elapsed from the onset of the previous episode.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 7-11 months schedule | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was
considered if at least 30-day interval elapsed from the onset of the previous episode.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Person Year Rate in prevention of all tympanostomy tube placements - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population) | ||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was
considered if at least 30-day interval elapsed from the onset of the previous episode.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[35] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
22.624
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
22.02 | ||||||||||||
upper limit |
23.24 | ||||||||||||
Notes [35] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978. |
|||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[36] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
22.747
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
21.912 | ||||||||||||
upper limit |
23.606 | ||||||||||||
Notes [36] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190. |
|||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[37] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
24.503
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
23.852 | ||||||||||||
upper limit |
25.166 | ||||||||||||
Notes [37] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181. |
|||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[38] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
26.236
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
25.308 | ||||||||||||
upper limit |
27.189 | ||||||||||||
Notes [38] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060. |
|||||||||||||
Statistical analysis title |
Statistical analysis 5 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[39] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
27.502
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
26.81 | ||||||||||||
upper limit |
28.207 | ||||||||||||
Notes [39] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914. |
|||||||||||||
Statistical analysis title |
Statistical analysis 6 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[40] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
26.1
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
25.171 | ||||||||||||
upper limit |
27.055 | ||||||||||||
Notes [40] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071. |
|||||||||||||
Statistical analysis title |
Statistical analysis 7 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[41] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
28.661
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
27.958 | ||||||||||||
upper limit |
29.377 | ||||||||||||
Notes [41] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913. |
|||||||||||||
Statistical analysis title |
Statistical analysis 8 | ||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Tympanostomy Tube Placements, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
[42] | ||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||
Parameter type |
PYAR | ||||||||||||
Point estimate |
29.835
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
28.843 | ||||||||||||
upper limit |
30.85 | ||||||||||||
Notes [42] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Tympanostomy Tube Placement divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414. |
|
|||||||||||||||||||
End point title |
Person Year Rate in prevention of all antimicrobial prescriptions- In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course | ||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). “For OM and RTI” category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course | ||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). “For OM and RTI” category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=24 months
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 7-11 months schedule | ||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). “For OM and RTI” category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Person Year Rate in prevention of all antimicrobial prescriptions - In children starting vaccination in the 12-18 months schedule (+ indirect effects on the unvaccinated population) | ||||||||||||||||||
End point description |
PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). “For OM and RTI” category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – FU mean time=27 months
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[43] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
816.813
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
815.226 | ||||||||||||||||||
upper limit |
818.392 | ||||||||||||||||||
Notes [43] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[44] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
841.176
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
839.098 | ||||||||||||||||||
upper limit |
843.239 | ||||||||||||||||||
Notes [44] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for Acute Otitis Media (AOM)/Respiratory Tract Infections (RTI), number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[45] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
702.245
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
700.372 | ||||||||||||||||||
upper limit |
704.114 | ||||||||||||||||||
Notes [45] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =229978. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[46] | ||||||||||||||||||
Method |
negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
720.9
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
718.355 | ||||||||||||||||||
upper limit |
723.435 | ||||||||||||||||||
Notes [46] - In 0 to 7 Years Old Population, in Year 2009, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =120190. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 5 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[47] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
929.844
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
928.755 | ||||||||||||||||||
upper limit |
930.923 | ||||||||||||||||||
Notes [47] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 6 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[48] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
953.025
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
951.77 | ||||||||||||||||||
upper limit |
954.257 | ||||||||||||||||||
Notes [48] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 7 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[49] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
804.703
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
803.017 | ||||||||||||||||||
upper limit |
806.38 | ||||||||||||||||||
Notes [49] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =214181. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 8 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[50] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
818.66
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
816.391 | ||||||||||||||||||
upper limit |
820.912 | ||||||||||||||||||
Notes [50] - In 0 to 7 Years Old Population, in Year 2010, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =112060. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 9 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[51] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
916.079
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
914.891 | ||||||||||||||||||
upper limit |
917.256 | ||||||||||||||||||
Notes [51] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 10 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[52] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
928.568
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
927.038 | ||||||||||||||||||
upper limit |
930.076 | ||||||||||||||||||
Notes [52] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 11 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[53] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
796.894
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
795.175 | ||||||||||||||||||
upper limit |
798.605 | ||||||||||||||||||
Notes [53] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =211914. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 12 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[54] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
803.918
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
801.571 | ||||||||||||||||||
upper limit |
806.25 | ||||||||||||||||||
Notes [54] - In 0 to 7 Years Old Population, in Year 2011, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111071. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 13 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[55] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
865.679
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
864.227 | ||||||||||||||||||
upper limit |
867.121 | ||||||||||||||||||
Notes [55] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 14 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[56] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
871.749
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
869.771 | ||||||||||||||||||
upper limit |
873.707 | ||||||||||||||||||
Notes [56] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 15 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any 10PN-PD-DIT vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
10Pn12-18M/043+053 Group v Ctrl12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[57] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
753.423
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
751.591 | ||||||||||||||||||
upper limit |
755.249 | ||||||||||||||||||
Notes [57] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received 10Pn-PD-DiT vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =213913. |
|||||||||||||||||||
Statistical analysis title |
Statistical analysis 16 | ||||||||||||||||||
Statistical analysis description |
For indirect effectiveness analysis at preventing Antimicrobial Prescriptions recommended for AOM/RTI, number of events in the unvaccinated cohort, which occurred around 6 months or more after study start was compared with treated group numbers (applicable to any control (HAV or HBV) vaccine - age stratum schedules).
|
||||||||||||||||||
Comparison groups |
Ctrl12-18M/043+053 Group v 10Pn12-18M/043+053 Group
|
||||||||||||||||||
Number of subjects included in analysis |
9660
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
[58] | ||||||||||||||||||
Method |
Negative Binomial model with strata | ||||||||||||||||||
Parameter type |
PYAR | ||||||||||||||||||
Point estimate |
755.542
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
753.008 | ||||||||||||||||||
upper limit |
758.064 | ||||||||||||||||||
Notes [58] - In 0 to 7 Years Old Population, in Year 2012, for Non-vaccinated persons living in study cluster areas, in which study participants received control vaccine, PYAR was calculated (= number of subjects reported with recommended Antimicrobial Prescriptions divided by sum of follow-up period expressed in years (per 1000), as well as 95% CI (2-sided profile log-likelihood ratio 95% CI using a Negative Binomial regression model with strata). Total number of non-vaccinated persons =111414. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects classified by antimicrobial susceptiblity of IPD isolates in children starting vaccination within 7 months of life and assigned to a 2 or 3-dose primary vaccination course | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antimicrobial susceptibility classification of IPD isolates reported during IPD follow-up with percentages for each serotype for the following categories: S= susceptible; I = intermediate ; R = resistant; N = not available.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) – mean FU time=24 months
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [59] - No participants with results in this group |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with Lower respiratory tract infections (LRTIs) (in a subset of 1500 subjects in Turku area) | ||||||||||||||||||||||||
End point description |
Analysis of this outcome in the Turku area was not performed as no data was collected related to LRTIs.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [60] - no data was collected related to LRTIs [61] - no data was collected related to LRTIs [62] - no data was collected related to LRTIs [63] - no data was collected related to LRTIs [64] - no data was collected related to LRTIs [65] - no data was collected related to LRTIs [66] - no data was collected related to LRTIs |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with Upper respiratory tract infections (URTIs) (in a subset of 1500 subjects in Turku area) | ||||||||||||||||||||||||
End point description |
Analysis of this outcome in the Turku area was not performed as no data was collected related to URTIs.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Notes [67] - no data was collected related to URTIs. [68] - no data was collected related to URTIs. [69] - no data was collected related to URTIs. [70] - no data was collected related to URTIs. [71] - no data was collected related to URTIs. [72] - no data was collected related to URTIs. [73] - no data was collected related to URTIs. |
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with SAEs reported during the blinded invasive disease phase, of the study | ||||||||||||||||||||||||
End point description |
An event is defined as ‘serious’ when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
For Month 0 till the end of the blinded ID Follow-Up, (at least 30 months from study start)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects enrolled and vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 study with post-study SAEs reported via passive surveillance– Subjects enrolled aged 6 weeks to 6 months and 7 to 18 months | ||||||||||||||||||||||||
End point description |
An event is defined as ‘serious’ when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.
Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
From the end of the blinded ID Follow-Up period(at least 30 months from study start) up to the end of 18-month period after study unblinding
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 3-dose primary vaccination course till end of LT FU period | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Culture-confirmed Invasive Disease (ID) Person Year Rate - In children starting vaccination within 7 months of life and assigned to a 2-dose primary vaccination course till end of LT FU period | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
SAEs were reported from Month 0 to end of blinded invasive disease (ID) phase (at least 30 months from study start), in 10PN-PD-DIT-043 subjects.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Solicited and unsolicited AEs were not collected in this study.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn3+1-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn2+1-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl-6W-6M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn7-11M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl7-11M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
10Pn12-18M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ctrl12-18M/043 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Only SAEs events were collected as part of this study. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
04 Feb 2009 |
Amendment 1 of the 10PN-PD-DIT-043 (111442) study protocol was developed for the following reasons: (1) Addition of collection of data on respiratory tract infections (RTIs), including acute otitis media (AOM) in a subset of subjects in Turku area; (2) Addition of 6 clusters located in some selected municipalities where no collaboration with health care centres had been set up but where there was opportunity for parent(s) to let their child participate in nested study 10PNPD-DIT-053 (112595) and to receive the same vaccination as in the current study (i.e. Espoo, Vantaa and surroundings municipalities and municipalities surrounding Oulu); and (3) The National Public Health Institute (KTL) and the National Research and Development Centre for Welfare and Health (STAKES) were merged into the National Institute for Health and Welfare (THL). |
||
22 Aug 2011 |
Amendment 2 was developed for the following reasons: (1) The study enrolment reached only 50% of the initial recruitment plan; therefore, there was a need to redefine the conditions for triggering IPD effectiveness analysis: (a) the study follow-up period for primary analysis on invasive disease (ID) cases was to end on 31 January 2012 (data lock point for ID cases), i.e. at least 30 months after study start. This would allow inclusion of an age-related IPD peak at 1119 months of age in the youngest enrolled subjects and an expected seasonal invasive pneumococcal disease (IPD) peak in the fall of 2011, thereby increasing the potential to accrue additional IPD cases; (b) Reaching a minimum number of 21 culture-confirmed vaccine-type IPD cases in the infant group was no longer a condition for triggering IPD effectiveness analysis because that minimum number was most probably not met due to the lower enrolment numbers. The estimated target number of vaccine-type IPD cases was adjusted accordingly, based on an assumed vaccine efficacy estimate and the currently available information on the total number of IPD cases by age cohort. Taking into account the lower than expected number of enrolled subjects, associated number of overall IPD cases reported so far and impact on power when considering 80% vaccine efficacy for the 2+1 vaccination schedule, it was decided to evaluate the effectiveness of the 10Pn-PD-DiT vaccine to prevent vaccine-type IPD in the infants assigned to a 2+1 vaccination course as a first secondary objective instead of the second primary objective (sequential) but to keep the predefined statistical criteria for success. (2) Following IDMC recommendation, it was decided to have the chest X-rays from the hospital-diagnosed pneumonia cases in the vaccinated population evaluated by an independent review panel according to World Health Organisation (WHO) guidelines for study purposes. The appropriate sections of the protocol were adjusted to reflect this. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |