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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655148
First Posted: April 9, 2008
Last Update Posted: January 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Statens Serum Institut
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00655148     History of Changes
Other Study ID Numbers: VIPV-03
First Submitted: April 3, 2008
First Posted: April 9, 2008
Last Update Posted: January 21, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs