Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine
Information source: Statens Serum Institut
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Active Immunization
Intervention: DTaP-IPV vero vaccine (Biological); DTaP-IPV mkc vaccine (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Statens Serum Institut Official(s) and/or principal investigator(s):
Jacek Pietrzyk, Proffessor M.D., Principal Investigator, Affiliation: Jagellonian University, Krakow, Poland
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.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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
Eligibility
Minimum age: N/A.
Maximum age: 49 Days.
Gender(s): Both.
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
Locations and Contacts
Centre Krakow, Krakow, Poland
Centre Wroclaw, Wroclaw, Poland
Centre Poznan, Poznan, Poland
Centre Bydgoszcz, Bydgoszcz, Poland
Centre Lodz, Lodz, Poland
Additional Information
Starting date: September 2003
Ending date: October 2006
Last updated: April 3, 2008
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