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Sponsored by: |
Statens Serum Institut |
Information provided by: | Statens Serum Institut |
ClinicalTrials.gov Identifier: | NCT00655148 |
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.
Condition | Intervention | Phase |
Active Immunization |
Biological: DTaP-IPV vero vaccine Biological: DTaP-IPV mkc vaccine |
Phase III |
MedlinePlus related topics: | Diphtheria Tetanus Whooping Cough |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 817 |
Study Start Date: | September 2003 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age
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Biological: DTaP-IPV vero vaccine
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
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B: Active Comparator
DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age
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Biological: DTaP-IPV mkc vaccine
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
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Ages Eligible for Study: | up to 49 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Poland | |||||
Centre Krakow | |||||
Krakow, Poland | |||||
Centre Wroclaw | |||||
Wroclaw, Poland | |||||
Centre Poznan | |||||
Poznan, Poland | |||||
Centre Bydgoszcz | |||||
Bydgoszcz, Poland | |||||
Centre Lodz | |||||
Lodz, Poland |
Statens Serum Institut |
Principal Investigator: | Jacek Pietrzyk, Proffessor M.D. | Jagellonian University, Krakow, Poland |
Responsible Party: | Statens Serum Institut, Division of Vaccine, Vaccine Development Department ( Ingrid Kromann ) |
Study ID Numbers: | VIPV-03 |
First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00655148 |
Health Authority: | Poland: Ministry of Health |
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