Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine

Study Overview
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Brief Summary
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The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh. Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.

Official Title
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Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age

Conditions
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Active Immunization

Intervention / Treatment
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* Biological: DTaP-IPV vero vaccine
* Biological: DTaP-IPV mkc vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The parents were informed about the trial and have signed the consent form The subject is healthy The subject has an age of 28 to 49 days at hepatitis B vaccination The subject had a birth weight of ≥2500 g The subject has received a hepatitis B vaccination at birth The parents grant access to the subject's medical records The parents are likely to comply with instructions Exclusion Criteria: The subject suffers from a severe chronic disease The subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or Hib vaccines The subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including Act-HIB® and hepatitis B vaccines The subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections The subject has a known congenital or acquired immunodeficiency The subject is in treatment with or has been in treatment with a product which is likely to modify the immune response (i.e. immunoglobulin, systemic corticosteroids, blood products, other vaccines) The subject is participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 49 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age | Biological: DTaP-IPV vero vaccine<br>* DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age<br>|
| Active Comparator: B<br>DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age | Biological: DTaP-IPV mkc vaccine<br>* DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types |  | One month after the third vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DTaP-IPV, Clinical Trial, Safety, Immunogenicity