Active Immunization
Conditions
Keywords
DTaP-IPV, Clinical Trial, Safety, Immunogenicity
Brief summary
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.
Interventions
BIOLOGICALDTaP-IPV vero vaccine
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
BIOLOGICALDTaP-IPV mkc vaccine
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Sponsors
Statens Serum Institut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
28 Days to 49 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Poland
Outcome results
None listed