Clinical Trial Results:
An open-label study to assess the immune persistence in healthy Chinese toddlers primed in infancy with three doses of GSK Biologicals’ DTPa-IPV/Hib vaccine, and to assess the safety and immunogenicity of a booster dose of IPV and DTPa/Hib administered at 18 to 24 months of age.
Summary
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EudraCT number |
2012-003324-20 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Jan 2012
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Results information
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Results version number |
v3(current) |
This version publication date |
18 May 2018
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First version publication date |
10 Jul 2015
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Other versions |
v1 , v2 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
114386
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01449812 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2989904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2989904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
01 Jul 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jan 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
•To assess the persistence of antibodies to all vaccine antigens before the booster dose.
•To assess the immune response to the study vaccines in terms of seroprotection to diphtheria, tetanus, Haemophilus influenzae type b and poliovirus types 1, 2 and 3, and in terms of vaccine response to the pertussis antigens, one month after booster vaccination.
•To assess the immune response to the study vaccines in terms of antibody concentrations or titres for all antigens, one month after the booster dose.
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Protection of trial subjects |
All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Oct 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
China: 825
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Worldwide total number of subjects |
825
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
825
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
6 subjects did not receive vaccination. | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Infanrix+Hib/Poliorix 1 Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix+Hib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Investigational medicinal product name |
Poliorix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Arm title
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Infanrix+Hib/Poliorix 2 Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix+Hib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4, 5 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Investigational medicinal product name |
Poliorix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4, 5 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Arm title
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Control Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib and of Poliorix vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix+Hib
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix+Hib vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Investigational medicinal product name |
Poliorix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects primed with 3 doses of the Infanrix+Hib vaccine at 2, 3, 4 months of age in the primary 112584 study, received 1 dose of Poliorix and of Infanrix+Hib vaccines at 18-24 months of age. The Poliorix and Infanrix+Hib vaccines were administered as an intramuscular (IM) injection into the upper sides of the left and right thighs, respectively.
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Baseline characteristics reporting groups
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Reporting group title |
Infanrix+Hib/Poliorix 1 Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix+Hib/Poliorix 2 Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib and of Poliorix vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Infanrix+Hib/Poliorix 1 Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||
Reporting group title |
Infanrix+Hib/Poliorix 2 Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||
Reporting group title |
Control Group
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Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib and of Poliorix vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
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End point title |
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations [1] | ||||||||||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against polyribosyl-ribitol-phosphate (Anti-PRP) [2] | ||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with Anti-PRP antibody concentration ≥ 0.15 microgram per milliliter (µg/mL). The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [2] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Anti-PRP antibody concentrations [3] | ||||||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [3] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for anti-polio type 1, 2 and 3 [4] | ||||||||||||||||||||||||
End point description |
The Anti-Polivirus cut-off value was defined as greater than or equal to 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection, by 50%. The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [4] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Anti-polio type 1, 2 and 3 antibody titers [5] | ||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titers (GMTs) for the seroprotection cut-off of ≥ 8. The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [5] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [6] | ||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a vaccinated subject with Anti-PT, Anti-FHA and Anti-PRN antibody concentration ≥ 5 (ELISA) units per milliliter (EL.U/ml). The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [6] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [7] | ||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/ml. The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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Notes [7] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) [8] | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with Anti-D and Anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL). The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
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End point type |
Primary
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End point timeframe |
One month after the booster vaccination (At Month 1)
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Notes [8] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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End point title |
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations [9] | ||||||||||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Day 0)
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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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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No statistical analyses for this end point |
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|||||||||||||
End point title |
Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP) [10] | ||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with Anti-PRP antibody concentration ≥ 0.15 microgram per milliliter (µg/mL). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||
Notes [10] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Anti-PRP antibody concentrations [11] | ||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||
Notes [11] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects for anti-polio type 1, 2 and 3 [12] | ||||||||||||||||||||||||
End point description |
The Anti-Polivirus cut-off value was defined as greater than or equal to 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection, by 50%. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||||||
Notes [12] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-polio type 1, 2 and 3 antibody titers [13] | ||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titers (GMTs) for the seroprotection cut-off of ≥ 8. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||||||||||
Notes [13] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [14] | ||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a vaccinated subject with Anti-PT, Anti-FHA and Anti-PRN antibody concentration ≥ 5 (ELISA) units per millilitre (EL.U/ml). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||||||
Notes [14] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [15] | ||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as Geometric Mean Concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/ml. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||||||||||
Notes [15] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with a booster response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [16] | ||||||||||||||||||||||||
End point description |
Booster response defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations >= cut-off value), taking into consideration the decreasing maternal antibodies. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||
Notes [16] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Number of seroprotected subjects against anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) [17] | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||
Notes [17] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-T) antibody concentrations [18] | ||||||||||||||||||||||||
End point description |
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||
Notes [18] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of seroprotected subjects against anti-polyribosylribitol phosphate (Anti-PRP) [19] | ||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||
Notes [19] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Anti-PRP antibody concentrations [20] | ||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||
Notes [20] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects for anti-polio type 1, 2 and 3 [21] | ||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||
Notes [21] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-polio type 1, 2 and 3 antibody titers [22] | ||||||||||||||||||||||||||||
End point description |
Titers were expressed as Geometric Mean Titers (GMTs) for the seroprotection cut-off of ≥ 8. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||||||
Notes [22] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [23] | ||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a vaccinated subject with Anti-PT, Anti-FHA and Anti-PRN antibody concentration ≥ 5 (ELISA) units per millilitre (EL.U/ml). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||
Notes [23] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [24] | ||||||||||||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
|
||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||||||||||||
Notes [24] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids [25] | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.
|
||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
Before the booster vaccination (At Day 0)
|
||||||||||||||||||||
Notes [25] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with any solicited local symptoms | ||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Number of subjects with any solicited general symptoms | ||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects with unsolicited AEs | ||||||||||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
During the 31-day (Days 0-30) post-vaccination period
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs). | ||||||||||||||||
End point description |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
During the entire study period (from Month 0 up to Month 1)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. AEs: within the 31-day (Days 0-30) period following booster vaccination. SAEs: throughout the entire study period.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix+Hib/Poliorix 1 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix+Hib/Poliorix 2 Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib and of Poliorix vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix and of Infanrix+Hib vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Solicited local symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited local symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited local symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited general symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited general symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited general symptoms were only tabulated for subjects with a symptom sheet completed. [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: Solicited general symptoms were only tabulated for subjects with a symptom sheet completed. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
12 Jul 2011 |
Due to significant revisions to the Chinese Pharmacopeia, the DTPa-IPV/Hib vaccine can currently not be locally retested and released in that country. The study design is therefore being modified to boost all subjects with the DTPa/Hib (Infanrix Hib) and IPV (Poliorix) vaccines. |
||
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 |