Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
NCT ID: NCT00655148
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
817 participants
INTERVENTIONAL
2003-09-30
2006-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A
DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age
DTaP-IPV vero vaccine
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
B
DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age
DTaP-IPV mkc vaccine
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Interventions
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DTaP-IPV vero vaccine
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
DTaP-IPV mkc vaccine
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Eligibility Criteria
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Inclusion Criteria
* 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 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
28 Days
49 Days
ALL
No
Sponsors
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Statens Serum Institut
OTHER
Responsible Party
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Principal Investigators
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Jacek Pietrzyk, Proffessor M.D.
Role: PRINCIPAL_INVESTIGATOR
Jagellonian University, Krakow, Poland
Locations
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Centre Bydgoszcz
Bydgoszcz, , Poland
Centre Krakow
Krakow, , Poland
Centre Lodz
Lodz, , Poland
Centre Poznan
Poznan, , Poland
Centre Wroclaw
Wroclaw, , Poland
Countries
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Other Identifiers
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VIPV-03
Identifier Type: -
Identifier Source: org_study_id
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