Clinical Trial Results:
An open, phase IIIb, randomized, multicentric clinical trial to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ DTPa-IPV vaccine versus co-administration of GSK Biologicals’ DTPa vaccine and Sanofi-Pasteurs’ IPV vaccine at different injection sites, to healthy children at 2, 4 and 6 months of age.
Summary
|
|
EudraCT number |
2015-001508-71 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
23 Jan 2007
|
Results information
|
|
Results version number |
v1 |
This version publication date |
27 Apr 2016
|
First version publication date |
10 Jul 2015
|
Other versions |
v2 |
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 |
104871
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00290342 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical 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) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
16 Nov 2007
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
23 Jan 2007
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
23 Jan 2007
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To demonstrate the non-inferiority of the DTPa-IPV vaccine to DTPa and IPV vaccines administered separately, in terms of antibody response against all vaccine antigens, one month after the three-dose primary vaccination course.
|
||
Protection of trial subjects |
The vaccines were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Jan 2006
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Korea, Republic of: 458
|
||
Worldwide total number of subjects |
458
|
||
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) |
458
|
||
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 |
- | |||||||||||||||||||||
Pre-assignment
|
||||||||||||||||||||||
Screening details |
Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code. | |||||||||||||||||||||
Pre-assignment period milestones
|
||||||||||||||||||||||
Number of subjects started |
458 | |||||||||||||||||||||
Number of subjects completed |
452 | |||||||||||||||||||||
Pre-assignment subject non-completion reasons
|
||||||||||||||||||||||
Reason: Number of subjects |
Consent withdrawn by subject: 6 | |||||||||||||||||||||
Period 1
|
||||||||||||||||||||||
Period 1 title |
Overall period
|
|||||||||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||
Blinding used |
Not blinded | |||||||||||||||||||||
Arms
|
||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||||||||
Arm title
|
Infanrix-IPV Group | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Infanrix™-IPV
|
|||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
|||||||||||||||||||||
Routes of administration |
Intramuscular use
|
|||||||||||||||||||||
Dosage and administration details |
Subjects received 3 doses of Infanrix™-IPV at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral thigh.
|
|||||||||||||||||||||
Arm title
|
Infanrix + IMOVAX Polio Group | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Infanrix™
|
|||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
|||||||||||||||||||||
Routes of administration |
Intramuscular use
|
|||||||||||||||||||||
Dosage and administration details |
Subjects received 3 doses of Infanrix™ co-administered with IMOVAX Polio® at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral sides of opposite thighs.
|
|||||||||||||||||||||
Investigational medicinal product name |
IMOVAX Polio®
|
|||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Injection
|
|||||||||||||||||||||
Routes of administration |
Intramuscular use
|
|||||||||||||||||||||
Dosage and administration details |
Subjects received 3 doses of Infanrix™ co-administered with IMOVAX Polio® at 2, 4 and 6 months of age as an intramuscular injection into the anterolateral sides of opposite thighs.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
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: Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code. |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix-IPV Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix + IMOVAX Polio Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Infanrix-IPV Group
|
||
Reporting group description |
- | ||
Reporting group title |
Infanrix + IMOVAX Polio Group
|
||
Reporting group description |
- |
|
||||||||||||||||
End point title |
Number of subjects with anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies above the cut-off. | |||||||||||||||
End point description |
||||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
One month after the three-dose primary vaccination course.
|
|||||||||||||||
|
||||||||||||||||
Statistical analysis title |
Non-inferiority in terms of vaccine response to D | |||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
|||||||||||||||
Number of subjects included in analysis |
415
|
|||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||
Analysis type |
non-inferiority [1] | |||||||||||||||
Method |
||||||||||||||||
Parameter type |
Difference in seroprotection rate | |||||||||||||||
Point estimate |
0
|
|||||||||||||||
Confidence interval |
||||||||||||||||
level |
95% | |||||||||||||||
sides |
2-sided
|
|||||||||||||||
lower limit |
-1.85 | |||||||||||||||
upper limit |
1.79 | |||||||||||||||
Notes [1] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
||||||||||||||||
Statistical analysis title |
Non-inferiority in terms of vaccine response to T | |||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
|||||||||||||||
Number of subjects included in analysis |
415
|
|||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||
Analysis type |
non-inferiority [2] | |||||||||||||||
Method |
||||||||||||||||
Parameter type |
Difference in seroprotection rate | |||||||||||||||
Point estimate |
0
|
|||||||||||||||
Confidence interval |
||||||||||||||||
level |
95% | |||||||||||||||
sides |
2-sided
|
|||||||||||||||
lower limit |
-1.85 | |||||||||||||||
upper limit |
1.79 | |||||||||||||||
Notes [2] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|
|||||||||||||||||||
End point title |
Number of subjects with anti-poliovirus (anti-polio) types 1, 2 and 3 above the cut-off. | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the three-dose primary vaccination course.
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-Polio 1 | ||||||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
||||||||||||||||||
Number of subjects included in analysis |
411
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [3] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
0
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-1.85 | ||||||||||||||||||
upper limit |
1.82 | ||||||||||||||||||
Notes [3] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-Polio 2 | ||||||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
||||||||||||||||||
Number of subjects included in analysis |
411
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [4] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
0.49
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-1.36 | ||||||||||||||||||
upper limit |
2.71 | ||||||||||||||||||
Notes [4] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-Polio 3 | ||||||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
||||||||||||||||||
Number of subjects included in analysis |
411
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [5] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
-0.01
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-2.28 | ||||||||||||||||||
upper limit |
2.24 | ||||||||||||||||||
Notes [5] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|
|||||||||||||||||||
End point title |
Number of subjects with anti-pertussis toxoid (anti-PT), anti-pertactin (anti-PRN) and anti-filamentous haemagglutinin (anti-FHA) antibodies above the cut-off. | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the three-dose primary vaccination course.
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-PT | ||||||||||||||||||
Comparison groups |
Infanrix + IMOVAX Polio Group v Infanrix-IPV Group
|
||||||||||||||||||
Number of subjects included in analysis |
415
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [6] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
1.44
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-0.46 | ||||||||||||||||||
upper limit |
4.13 | ||||||||||||||||||
Notes [6] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-FHA | ||||||||||||||||||
Comparison groups |
Infanrix-IPV Group v Infanrix + IMOVAX Polio Group
|
||||||||||||||||||
Number of subjects included in analysis |
415
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [7] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
0.45
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-1.88 | ||||||||||||||||||
upper limit |
2.95 | ||||||||||||||||||
Notes [7] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|||||||||||||||||||
Statistical analysis title |
Immune response non-inferiority - Anti-PRN | ||||||||||||||||||
Comparison groups |
Infanrix + IMOVAX Polio Group v Infanrix-IPV Group
|
||||||||||||||||||
Number of subjects included in analysis |
415
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [8] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in seroprotection rate | ||||||||||||||||||
Point estimate |
0.47
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-1.4 | ||||||||||||||||||
upper limit |
2.64 | ||||||||||||||||||
Notes [8] - To assess the Non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%. |
|
|||||||||||||||||||
End point title |
Number of subjects with vaccine response to PT, PRN and FHA. [9] | ||||||||||||||||||
End point description |
The subjects were initially (i.e. before vaccination) seronegative (i.e. with concentrations < 5 EL.U/mL), or at least maintenance of pre-vaccination antibody concentrations in subjects who are initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the three-dose primary vaccination course.
|
||||||||||||||||||
Notes [9] - 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 |
Number of subjects with anti-D and anti-T antibodies above the cut-offs. | |||||||||||||||||||||
End point description |
||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
Before the first dose at the first study visit and one month after the three-dose primary vaccination course.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Concentrations for anti-D and anti-T. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Before the first dose at the first study visit and one month after the three-dose primary vaccination course.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Titers for anti-polio 1, 2 and 3. | ||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Before the first dose at the first study visit and one month after the three-dose primary vaccination course.
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Concentrations for anti-PT, anti-FHA and anti-PRN. | ||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||
End point timeframe |
Before the first dose at the first study visit and one month after the three-dose primary vaccination course.
|
||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects reporting solicited local symptoms. | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
During the 4-day (Day 0-3) follow up period after vaccination.
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects reporting solicited general symptoms. | |||||||||||||||||||||
End point description |
||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
During the 4-day (Day 0-3) follow up period after vaccination.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any unsolicited adverse events (AEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the 31-day (Day 0-30) follow-up period after vaccination.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited symptoms during the 4-day post-vaccination period, Unsolicited AEs during the 31-day post-vaccination period and SAEs during the entire period
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix-IPV Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix + IMOVAX Polio Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
27 Oct 2005 |
This amendment was written to reflect the changes in study design following discussions with KFDA, ad to clarify some study aspects. Major changes in study design being:
- Usage of IMOVAX Polio™ instead of IPOL® in the study. Both vaccines are manufactured by Sanofi-Pasteur and both have the same content. IMOVAX Polio™ will be used instead of IPOL® in order to source the vaccine supply directly from Belgium instead of the United States.
- Perform Hib vaccine administration out of the study context.
- Inclusion of vaccine response to pertussis antigens as a primary endpoint and recalculation of sample size accordingly.
|
||
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 |