Clinical Trial Results:
Clinical Otitis Media and Pneumonia Study (COMPAS): a phase III , double-blind, randomized, controlled, multicentre study to demonstrate the efficacy of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine (GSK1024850A) against Community Acquired Pneumonia (CAP) and Acute Otitis Media (AOM)
Summary
|
|
EudraCT number |
2011-002076-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Jul 2011
|
Results information
|
|
Results version number |
v2(current) |
This version publication date |
16 Oct 2020
|
First version publication date |
15 May 2015
|
Other versions |
v1 |
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 |
109563
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00466947 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium,
|
||
Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 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 |
21 Feb 2014
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
28 Jul 2011
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To demonstrate the efficacy of a 3-dose primary course followed by a booster dose in the second year of life with the 10Pn-PD-DiT vaccine against likely bacterial CAP cases (B-CAP) in the entire study cohort. Likely bacterial CAP is defined as radiologically confirmed CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray (CXR), or with non-alveolar infiltrates but with C-reactive protein (CRP) ≥ 40 mg/L.
|
||
Protection of trial subjects |
Subjects’ safety was monitored in the study via the following measures and practice: Prior to the study: check of inclusion and exclusion criteria prior to enrolment, completed with check on gestational age, medical and pre-vaccination history of subjects; Throughout the study: regular check for exclusion criteria for further study participation, for risk factors, and for warnings, precautions and contraindications to the vaccine administered.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
28 Jun 2007
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Argentina: 13981
|
||
Country: Number of subjects enrolled |
Colombia: 2483
|
||
Country: Number of subjects enrolled |
Panama: 7359
|
||
Worldwide total number of subjects |
23823
|
||
EEA total number of subjects |
0
|
||
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) |
23823
|
||
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 |
Primary outcome analysis was on 31 August 2010, when at least 535 first bacterial CAP episodes reported from 2 weeks after Dose 3 – total population: 11875 & 11863 subjects in Synflorix and Control groups; according to protocol efficacy cohort: 10295 & 10201 subjects in Synflorix and Control groups. Study end analysis was done on 23597 subjects. | ||||||||||||||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||
Screening details |
During the screening, the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing of informed consent forms by parent(s)/guardian(s). | ||||||||||||||||||||||||||||||||||||
Pre-assignment period milestones
|
|||||||||||||||||||||||||||||||||||||
Number of subjects started |
23823 | ||||||||||||||||||||||||||||||||||||
Number of subjects completed |
23597 | ||||||||||||||||||||||||||||||||||||
Pre-assignment subject non-completion reasons
|
|||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Protocol deviation: 226 | ||||||||||||||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall trial (overall period)
|
||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Carer, Subject, Investigator, Monitor, Data analyst | ||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||
Arm title
|
Synflorix Group | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV + Hib) thigh (primary dose) or deltoid (booster dose). | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Synflorix
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
10Pn, 10Pn-PD-DiT, GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, Synflorix™, GSK1024850A
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received 3 primary doses at 2, 4 and 6 months, administered in the right thigh,and a booster dose at 15-18 months administered in the right thigh or deltoid.
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix-IPV + Hib
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
Infanrix-IPV/Hib
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received one dose administered at 15-18 months of age in the left thigh or deltoid.
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix Hexa
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
DTPa-IPV-HBV / Hib, GSK Biologicals’ diphtheria-tetanus-acellular pertussis, hepatitis B virus-inactivated poliovirus and Haemophilus influenzae type b vaccine
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received 3 primary doses at 2, 4 and 6 months administered in the left thigh.
|
||||||||||||||||||||||||||||||||||||
Arm title
|
Control Group | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received 3 doses of Engerix B at 2,4 and 6 months of age co-administered with Infanrix-IPV + Hib and 1 dose of Havrix 720 Junior co-administered with Infanrix-IPV + Hib at 15-18 months of age. All vaccine were administered in the right (Engerix B Junior, Havrix) or the left (Infanrix-IPV + Hib) thigh. | ||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Engerix B Junior
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
HBV, Engerix B
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received 3 doses at 2,4 and 6 months of age, administered in the right thigh.
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix-IPV + Hib
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
Infanrix-IPV/Hib
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received 3 primary doses at 2,4 and 6 months of age, administered in in the left thigh and one booster dose at 15-18 months of age administered in the left thigh or deltoid.
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Havrix 720 Junior
|
||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||
Other name |
HAV, Hepatitis A vaccine (inactivated), Havrix
|
||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Subjects received 1 dose at 15-18 months of age administered in the right thigh.
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
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: Among the initial 23823 subjects enrolled in the study, 3 were not allocated to any groups and 2 had non-valid informed consent. In addition, analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Synflorix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV + Hib) thigh (primary dose) or deltoid (booster dose). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received 3 doses of Engerix B at 2,4 and 6 months of age co-administered with Infanrix-IPV + Hib and 1 dose of Havrix 720 Junior co-administered with Infanrix-IPV + Hib at 15-18 months of age. All vaccine were administered in the right (Engerix B Junior, Havrix) or the left (Infanrix-IPV + Hib) thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Synflorix Group
|
||
Reporting group description |
Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV + Hib) thigh (primary dose) or deltoid (booster dose). | ||
Reporting group title |
Control Group
|
||
Reporting group description |
Subjects received 3 doses of Engerix B at 2,4 and 6 months of age co-administered with Infanrix-IPV + Hib and 1 dose of Havrix 720 Junior co-administered with Infanrix-IPV + Hib at 15-18 months of age. All vaccine were administered in the right (Engerix B Junior, Havrix) or the left (Infanrix-IPV + Hib) thigh. |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacterial community acquired pneumoniae (B-CAP) [1] | ||||||||||||
End point description |
A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed ICF issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Any time from 2 weeks after Dose 3 up to 31 August 2010
|
||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Time to First or Only Episode of B-CAP | |||||||||||||||
End point description |
The total time to a first episode reported of bacterial community acquired pneumoniae (B-CAP) was tabulated. A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed when at least 535 first B-CAP episodes were reported from 2 weeks after Dose 3 of vaccine. After analysis was performed, re-monitoring activities revealed ICF issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed, which confirmed the validity of the results for primary outcome.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
Any time from 2 weeks after Dose 3 up to 31 August 2010
|
|||||||||||||||
|
||||||||||||||||
Statistical analysis title |
Vaccine Efficacy for time to first B-CAP episode | |||||||||||||||
Statistical analysis description |
The vaccine efficacy (VE) to prevent the first episode of B-CAP was estimated with 95% confidence interval (CI), as (1 minus the hazard ratio) times 100 obtained from a Cox regression model including the treatment group (Synflorix Group) as only regressor. Censoring occurred either at the time of the last contact, of unblinding or at 18 months of age if the booster dose was not administered or was administered at a later age.
|
|||||||||||||||
Comparison groups |
Synflorix Group v Control Group
|
|||||||||||||||
Number of subjects included in analysis |
20496
|
|||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||
Analysis type |
superiority [2] | |||||||||||||||
P-value |
= 0.002 [3] | |||||||||||||||
Method |
Regression, Cox | |||||||||||||||
Parameter type |
VE (see above) | |||||||||||||||
Point estimate |
22.033
|
|||||||||||||||
Confidence interval |
||||||||||||||||
level |
95% | |||||||||||||||
sides |
2-sided
|
|||||||||||||||
lower limit |
7.656 | |||||||||||||||
upper limit |
34.172 | |||||||||||||||
Notes [2] - Vaccine efficacy analysis, based on a Cox regression proportional hazard model [3] - Statistical significance was reached if the one-sided p-value for the Wald-Test obtained from the Cox proportional hazard model calculated for the null hypothesisH0= [B-CAP VE =< 0%] (Y = Time to Event) was lower than 0.0175. |
|
|||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Throughout the study (Month 0 to Month 22-25)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with any unsolicited adverse event (AE), in the Panama Subset | ||||||||||||
End point description |
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Throughout the study (Month 0 to Month 22-25)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms post primary vaccination in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [4] - The endpoint solely concerns the Synflorix Group. |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms post booster vaccination in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [5] - The endpoint solely concerns the Synflorix Group. |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms post primary vaccination in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [6] - The endpoint solely concerns the Control Group. |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms post booster vaccination in the Immunogenicity and Tolerability Subset, for the Control Group | |||||||||||||||||||||||||||
End point description |
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
Notes [7] - The endpoint solely concerns the Control Group. |
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with solicited general symptoms post primary vaccination in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||
End point description |
Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with solicited general symptoms post booster vaccination in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||
End point description |
Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of clinically confirmed acute otitis media (AOM) (C-AOM), in the Panama Subset | ||||||||||||
End point description |
The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks after Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with alveolar consolidation or pleural effusion on the chest X-ray (CXR) (C-CAP) | ||||||||||||
End point description |
CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to any bacterial pathogen, in the Panama Subset | ||||||||||||
End point description |
The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Streptococcus pneumoniae (S. pn.) vaccine serotypes, in the Panama Subset | ||||||||||||
End point description |
The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Streptococcus pneumoniae (S. pn.) cross-reactive serotypes, in the Panama Subset. | ||||||||||||
End point description |
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to other pneumococcal serotypes, in the Panama Subset. | ||||||||||||
End point description |
Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Haemophilus influenzae (H. influenzae), in the Panama Subset | ||||||||||||
End point description |
The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to non-typeable Haemophilus influenzae (H. influenzae), in the Panama Subset | ||||||||||||
End point description |
The Panama Subset contained all subjects enrolled in Panama
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to other AOM pathogens, in the Panama Subset | ||||||||||||
End point description |
Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with alveolar consolidation or pleural effusion on the Chest X-ray (CXR) (C-CAP) with positive respiratory viral test (RVT) | ||||||||||||
End point description |
A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with any abnormal CXR with positive respiratory viral test (RVT) | ||||||||||||
End point description |
An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of bacterial community acquired pneumoniae (B-CAP) with positive respiratory viral test (RVT). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of suspected community acquired pneumoniae (CAP) (S-CAP) | ||||||||||||
End point description |
An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with any abnormal chest X-ray (CXR) | ||||||||||||
End point description |
An “abnormal CXR” was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects with a first episode reported of suspected community acquired pneumoniae (CAP) (S-CAP) with C reactive protein (CRP) >= cut-off, regardless of chest X-ray (CXR) reading | ||||||||||||||||||
End point description |
A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with a first episode reported of CAP with either alveolar consolidation/pleural effusion on chest X-ray (CXR) (C-CAP) or with non-alveolar infiltrates (NAI-CAP) but with C reactive protein (CRP) >= cut-off. | |||||||||||||||
End point description |
CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of vaccine-type invasive pneumococcal disease (VT-IPD). | ||||||||||||
End point description |
A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of a bacteriologically confirmed invasive pneumococcal disease (Bact.-conf. ID). | ||||||||||||
End point description |
A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of pneumococcal invasive disease (Pneumococcal ID) | ||||||||||||
End point description |
A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of Invasive Pneumococcal Disease (IPD) due to Streptococcus (S. pn.) cross-reactive pneumococcal serotypes. | ||||||||||||
End point description |
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of Invasive Pneumococcal Disease (IPD) due to pneumococcal serotypes other than Streptococcus (S. pn.) vaccine and cross-reactive serotypes. | ||||||||||||
End point description |
The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with a first episode reported of invasive disease (ID) due to Haemophilus influenzae | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with Streptococcus pneumoniae (S. pn.) vaccine serotypes identified in nasopharyngeal swabs, in the Carriage Subset. | |||||||||||||||||||||||||||
End point description |
The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with Streptococcus pneumoniae (S. pn.) cross-reactive serotypes identified in nasopharyngeal swabs, in the Carriage Subset. | |||||||||||||||||||||||||||
End point description |
Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with Streptococcus pneumoniae (S. pn.) serotypes identified in nasopharyngeal swabs other than the Synflorix vaccine and cross-reactive serotypes, in the Carriage Subset | |||||||||||||||||||||||||||
End point description |
S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with H. influenzae strains identified in nasopharyngeal swabs, in the Carriage subset | |||||||||||||||||||||||||||
End point description |
Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with acquisition of new Streptococcus pneumoniae strains identified in nasopharyngeal swabs, in the Carriage Subset | ||||||||||||||||||||||||
End point description |
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Months 10-13, 13-16, 14-17, 16-19 and 22-25
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with acquisition of new Haemophilus influenzae strains identified in nasopharyngeal swabs, in the Carriage Subset. | ||||||||||||||||||||||||
End point description |
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Months 10-13, 13-16, 14-17, 16-19 and 22-25
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with any antibiotic prescription at least once during the entire study period, in the Carriage Subset. | ||||||||||||
End point description |
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Throughout the study (Month 0 to Month 22-25)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Pneumococcal antibody concentrations against pneumococcal vaccine serotypes, in the Immunogenicity and Tolerability Subset. | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Antibody concentrations against pneumococcal vaccine serotypes, in the Immunogenicity and Tolerability Subset. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ||||||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with antibody concentrations against pneumococcal vaccine serotypes >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with antibody concentrations against pneumococcal vaccine serotypes >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with pneumococcal antibody concentrations against cross-reactive serotypes 6A and 19A higher >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 microgram per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with pneumococcal antibody concentrations against serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | |||||||||||||||
End point description |
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 microgram per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with pneumococcal antibody concentrations against serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | ||||||||||||||||||||||||||||||||||||||||||
End point description |
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset | ||||||||||||||||||
End point description |
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Titers for Opsonophagocytic activity against pneumococcal serotypes 6A and 19A in the Immunogenicity and Tolerability Subset | ||||||||||||||||||||||||||||||
End point description |
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | |||||||||||||||
End point description |
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||||||||
End point description |
A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Concentrations of antibodies against protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | |||||||||||||||
End point description |
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Concentrations of antibodies against protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset | |||||||||||||||||||||
End point description |
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with anti-protein D (ANTI-PD) antibody concentrations >= 100 enzyme-linked immunosorbent assay units per milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset | ||||||||||||
End point description |
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 5, one month after the third dose of primary vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects with anti-protein D (ANTI-PD) antibody concentrations >= 100 enzyme-linked immunosorbent assay units per milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset. | ||||||||||||||||||
End point description |
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 Post-BST)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
SAEs and unsolicited AEs: Throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day (Days 0–3) follow-up period across the 3 doses of primary study vaccine course/ 4-day (Days 0–3) follow-up period post booster vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
SAEs reports were collected based on the Total Vaccinated cohort. Reports for unsolicited and solicited AEs were collected based on the TVC, from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively. Occurrences of AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Synflorix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [38] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [39] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [40] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [41] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [42] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [43] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [44] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [45] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [46] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [47] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [48] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [49] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [50] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [51] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [52] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [53] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
26 Nov 2007 |
The following changes were implemented in this Amendment 1. Firstly, study centres in Colombia were added. Secondly, a new subset (‘Additional immuno’ subset) of subjects in Panama was added for further exploration after study end of the correlation between protection against of Acute Otitis Media (AOM) episodes caused by (non-typeable) H. influenzae and results of the measurement and characterization of responses induced by the protein D carrier protein. Thirdly, the Reference Laboratory was changed from Instituto Malbrán in Argentina to Eurofins in the United States, which implied adaptations to the laboratory procedures. Fourthly, an appendix was added about the background of AOM severity scales and their application in the study. |
||
20 Mar 2008 |
The following changes were implemented in this Amendment 2. Firstly, in Colombia, two doses of HRV (Rotarix) vaccine would be offered to all subjects within the first six months of life to provide additional benefit. Secondly, in Panama, subjects who were part of the ‘Carriage’ subset were also given the opportunity to participate in the ‘Additional immuno’ subset. However, subjects who were part of the ‘Immunogenicity and Tolerability’ subset would not be invited to participate in the ‘Additional immuno’ subset as already four blood samples were to be collected from these subjects. Thirdly, for preterm infants the gestation period had been defined. Fourth, in case subjects would by mistake receive a vaccine with antigens common to the antigens contained in the study or co-administered vaccines outside of the context of the study, the investigator would need to evaluate whether the subject could still continue participation in the study. Therefore this criterion was added to the exclusion criteria for further study participation. Fifth, for subjects in the ‘Additional immuno’ subset, a visit was removed from the list of study procedures and the detailed description of study procedures. Sixth, new validated temperature monitoring devices had been provided to the investigational sites. Although the temperature monitoring process described in protocol still covered the use of these new devices, the related section was updated with the mandatory text of the current protocol document standard to avoid confusion. Seventh, the classification of the CXR was aligned throughout the protocol and with the Radiology workbook. Eighth, additional minor changes and clarifications were implemented. |
||
25 Nov 2008 |
This protocol amendment - Amendment 3 – was developed in reply to questions from local authorities. Firstly, the recruitment period was extended to 18 months. Secondly, subjects diagnosed to be at high risk for Invasive pneumococcal disease (IPD) were excluded from the study in case a specific local vaccination program was available. Thirdly, the informed consent process for minor parents (<18 years of age) was specified. Fourth, additional minor changes and clarifications were implemented. |
||
11 May 2009 |
This protocol amendment – Amendment 4 – was developed in reply to questions from local authorities. Additions were, 1) in the exclusion criteria for further study participation the criteria for high risk for pneumococcal disease were specified and 2) clarification on how to proceed in case of diagnosis of a high risk condition for pneumococcal infection was added. |
||
14 Dec 2009 |
Changes were implemented in the protocol Amendment 5 towards taking into account that the number of AOM cases reported to that date was much lower than anticipated. To be able to perform the interim analysis to evaluate the efficacy of the 10Pn-PD-DiT/Synflorix vaccine to prevent the first episodes of B-CAP regardless of the number of cases of C-AOM that would be reached, it was decided to evaluate the vaccine efficacy (VE) to prevent the first episodes of B-CAP as the only primary objective, and to evaluate the VE to prevent the first episodes of C-AOM as a secondary objective instead of a co-primary objective. The number of B-CAP cases needed to perform the interim analysis was adjusted accordingly. |
||
09 Sep 2010 |
This protocol Amendment 6 was developed for the following reasons. Firstly, as the observed incidence of B-CAP was lower than the expected incidence, the number of cases needed to perform the final analysis would not be reached in the near future and might never be reached based on extrapolation of the accrual of B-CAP cases. As this study had been designed to determine VE against pneumonia, which is a major burden in Latin America and the rest of the world, results should be reported in a timely manner. Therefore GSK Biologicals decided to amend the protocol to re-define the study end based on the outcome of the planned interim analysis. Secondly, in addition, clarifications to the objectives and endpoints were implemented and wordings were corrected to align with the change in the primary objective implemented in previous amendment dated 14 December 2009). Thirdly, contact details for the emergency code break were updated. |
||
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 |