Clinical trial NCT00655148: Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Immunization
Keywords: DTaP-IPV
Clinical Trial
Safety
Immunogenicity
Lead sponsor: Statens Serum Institut
Sponsor class: OTHER
First posted: 2008-04-09
Enrollment: 817
Sex: ALL
Minimum age (years): 28
Maximum age (years): 49
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: One month after the third vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Centre Bydgoszcz
city: Krakow
country: Poland
facility: Centre Krakow
city: Lodz
country: Poland
facility: Centre Lodz
city: Poznan
country: Poland
facility: Centre Poznan
city: Wroclaw
country: Poland
facility: Centre Wroclaw
Study officials:
affiliation: Jagellonian University, Krakow, Poland
name: Jacek Pietrzyk, Proffessor M.D.
role: PRINCIPAL_INVESTIGATOR
References: