Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00655148
First received: April 3, 2008
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • 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 [ Time Frame: One month after the third vaccination ] [ Designated as safety issue: No ]

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
Experimental: A
DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age
Biological: DTaP-IPV vero vaccine
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Active Comparator: B
DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age
Biological: DTaP-IPV mkc vaccine
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age

  Eligibility

Ages Eligible for Study:   up to 49 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655148

Locations
Poland
Centre Bydgoszcz
Bydgoszcz, Poland
Centre Krakow
Krakow, Poland
Centre Lodz
Lodz, Poland
Centre Poznan
Poznan, Poland
Centre Wroclaw
Wroclaw, Poland
Sponsors and Collaborators
Statens Serum Institut
Investigators
Principal Investigator: Jacek Pietrzyk, Proffessor M.D. Jagellonian University, Krakow, Poland
  More Information

No publications provided

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00655148     History of Changes
Other Study ID Numbers: VIPV-03
Study First Received: April 3, 2008
Last Updated: January 18, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by Statens Serum Institut:
DTaP-IPV
Clinical Trial
Safety
Immunogenicity

ClinicalTrials.gov processed this record on April 15, 2014