Clinical Trial Results:
Safety and Immunogenicity of Booster Vaccination with PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination with Infanrix® hexa when Both Vaccines Are Co-Administered with Prevenar® to Toddlers 11-18 Months of Age
Summary
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EudraCT number |
2006-000898-30 |
Trial protocol |
DE |
Global end of trial date |
17 Sep 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2016
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First version publication date |
30 Jan 2015
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Other versions |
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 |
A5I19
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00355654 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
1 Discovery Drive, Swiftwater, United States, 18370
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Public contact |
Associate Vice President, Clinical Development, Sanofi Pasteur Inc, +1 (570) 957-3570, emilia.jordanov@sanofipasteur.com
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Scientific contact |
Associate Vice President, Clinical Development, Sanofi Pasteur Inc, +1 (570) 957-3570, emilia.jordanov@sanofipasteur.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Jul 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Sep 2007
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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 evaluate the safety of PEDIACEL® booster dose by comparing the fever rates between PEDIACEL® and Infanrix® hexa vaccines when both are co-administered with Prevenar® to toddlers at 11-18 months of age.
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
The control, Infanrix® hexa, is a licensed combination vaccine. | ||
Actual start date of recruitment |
29 Sep 2006
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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 |
Germany: 847
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Worldwide total number of subjects |
847
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EEA total number of subjects |
847
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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) |
847
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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 |
Study subjects were enrolled from 29 September 2006 to 29 June 2007 at 53 clinical centers in Germany. | |||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 847 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled; 845 were vaccinated. | |||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator, Assessor | |||||||||||||||||||||
Blinding implementation details |
Subjects and assessors were blinded to the vaccine. Each site had 1 designated person who was unblinded to the randomisation/vaccine administered and was responsible for the preparation and administration of the vaccine. All others remained blinded to the vaccine group until after the safety assessment. Before the assessment, the code was broken if it was necessary to determine/influence treatment of serious AEs. It was also broken afterwards for Pediacel subjects to receive ENGERIX-B Kinder.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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PEDIACEL | |||||||||||||||||||||
Arm description |
Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
PEDIACEL
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Investigational medicinal product code |
HCPDT-IPV-PRP-T
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular injection into the deltoid muscle, one dose at 11-18 months of age.
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Investigational medicinal product name |
Prevenar
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Investigational medicinal product code |
Pneumococcal saccharide conjugated vaccine, adsorb
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular into the deltoid muscle, one dose at 11-18 months of age.
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Investigational medicinal product name |
ENGERIX-B Kinder
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Investigational medicinal product code |
Hepatitis B recombinant vaccine, adsorbed
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular injection into the deltoid muscle, one dose at 12-19 months of age.
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Arm title
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Infanrix hexa | |||||||||||||||||||||
Arm description |
Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months. | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Infanrix hexa
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Investigational medicinal product code |
DTPa-HBV-IPV+Hib
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular injection into the deltoid muscle, one dose at 11-18 months of age.
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Investigational medicinal product name |
Prevenar
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Investigational medicinal product code |
Pneumococcal saccharide conjugated vaccine, adsorb
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, intramuscular into the deltoid muscle, one dose at 11-18 months of age.
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Baseline characteristics reporting groups
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Reporting group title |
PEDIACEL
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Reporting group description |
Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix hexa
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Reporting group description |
Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
PEDIACEL
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Reporting group description |
Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months. | ||
Reporting group title |
Infanrix hexa
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Reporting group description |
Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months. |
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End point title |
Number of Subjects Reporting Fever Within Four Days of Booster Vaccination With Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||
End point description |
Fever was defined as a temperature ≥ 38.0°C.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 4 post-vaccination
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Statistical analysis title |
Non-Inferiority of PEDIACEL to Infanrix Hexa | |||||||||||||||
Statistical analysis description |
Non-Inferiority of PEDIACEL to Infanrix Hexa with respect to Fever rates (≥ 38.0°C) within 4 Days post-booster vaccination when both were co-administered with Prevenar.
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Comparison groups |
PEDIACEL v Infanrix hexa
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Number of subjects included in analysis |
843
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||||||||
Method |
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Parameter type |
Mean difference (final values) | |||||||||||||||
Point estimate |
-3.1
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-9.7 | |||||||||||||||
upper limit |
3.4 | |||||||||||||||
Notes [1] - Non-inferiority is achieved if the upper limit of the two-sided 95% CI of PEDIACEL - Infanrix hexa is < 10% (primary objective). Difference= PEDIACEL fever rate - Infanrix hexa fever rate. The CIs were computed using the normal approximation to the binomial distribution without continuity correction. |
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End point title |
Number of Subjects Reporting Severe Fever Within Four Days Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | ||||||||||||||||||
End point description |
Severe fever was defined as a temperature of ≥ 39.6°C.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 4 post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Seroprotection Against Vaccine Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibodies were measured by radioimmunoassay for polyribosylribitol phosphate (PRP); serum neutralization assay for diphtheria toxoid and poliovirus types 1, 2, and 3; and enzyme-linked immunosorbent assay for tetanus toxoid and all pneumococcal serotypes. Seroprotection was defined as titers of ≥1.0 µg/mL for PRP, ≥0.1 µg/mL for diphtheria toxoid and tetanus toxoid, ≥1:8 [1/dil] for poliovirus 1, 2, and 3, and ≥0.15 µg/mL for all pneumococcal serotypes.
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End point type |
Secondary
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End point timeframe |
1 month post-vaccination
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibodies were measured by radioimmunoassay for polyribosylribitol phosphate (PRP); serum neutralization assay for diphtheria toxoid and poliovirus types 1, 2, and 3; enzyme-linked immunosorbent assay for tetanus toxoid, all pneumococcal (Pneumo 4, 6B, 9V, 14, 18C, 19F, 23F) serotypes, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM).
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination) and 1 month post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Booster Response for Pertussis Antigens Post- Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | ||||||||||||||||||||||||
End point description |
Antibodies were measured using an enzyme-linked immunosorbent assay for pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM). Booster response was defined as ≥ 4-fold rise from baseline if baseline antibody response was < 4x lower limit of quantification (LLOQ) or ≥ 2-fold rise from baseline if baseline antibody response was ≥ 4xLLOQ.
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination) to 1 month post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Seroprotection Against Hepatitis B Antigens Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||||||||
End point description |
Anti-Hepatitis B antibodies were measured using enhanced chemiluminescence [ECi]). Seroprotection was defined as titers at the level of ≥ 10 mIU/mL for Hepatitis B.
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End point type |
Secondary
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End point timeframe |
1 month post-vaccination
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No statistical analyses for this end point |
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End point title |
Geometric Mean Titers (GMTs) of Antibodies to Hepatitis B Antigens Before and Following Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||||||||
End point description |
Anti-Hepatitis B antibodies were measured using enhanced chemiluminescence [ECi]).
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End point type |
Secondary
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End point timeframe |
Day 0 (pre-vaccination) to 1 month post-vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Any Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-each vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting a Solicited Injection Site or Systemic Reactions Following Each Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3 injection site: Tenderness – Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling – ≥5 cm. Grade 3 systemic reactions: Fever – ≥39.6°C; Vomiting – ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal – >3 hours; Drowsiness – Sleeping most of the time or difficulty to wake up; Appetite loss – refuses ≥ 3 feeds or refuses most feeds; and Irritability– Inconsolable.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-each vaccination
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Extensive Limb Swelling Following Booster Vaccination with Either PEDIACEL or Infanrix Hexa Vaccine | |||||||||||||||
End point description |
Extensive limb swelling is defined as swelling extending from the injection site beyond 1 or both adjacent joints (i.e., elbow and/or shoulder).
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-each vaccination
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected from Day 0 (post-vaccination) up to 1 month post-vaccination.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9.0
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Reporting groups
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Reporting group title |
PEDIACEL
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Reporting group description |
Subjects who received PEDIACEL (0.5 mL) as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months followed by ENGERIX-B Kinder (0.5 mL) 1 month later, at 12 to 19 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix hexa
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Reporting group description |
Subjects who received Infanrix hexa as a booster dose (following a primary series with a hexavalent vaccine) administered concomitantly with the first dose of Prevenar (0.5 mL) at 11 to 18 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Jun 2006 |
Infant inclusion criteria were revised to meet the current practices of infant immunizations in Germany, visit procedures were revised to standardize a definition of "whole limb swelling", List of Investigators were updated, and the consent form was further revised to clarify compliance with immunization requirements and possible benefits. |
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15 Sep 2006 |
Batch numbers of the vaccines were added, List of Investigators were updated, and the consent form was further revised to clarify compliance with immunization requirements. |
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21 Mar 2007 |
Retrospective power calculations were added, assay methodology was updated, and List of Investigators were updated. |
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12 Sep 2007 |
PRP testing and the List of Investigators were updated. |
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14 Sep 2007 |
Polio testing and the definition of fever were updated, two per protocol analysis sets were defined to reflect different testing schedules, the temperature condition for the sera storage was removed, and the CTL was updated in the List of Participants. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |