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

Sponsor:	Statens Serum Institut
Information provided by:	Statens Serum Institut
ClinicalTrials.gov Identifier:	NCT00655148

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 III

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:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

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:	Ingrid Kromann, Statens Serum Institut, Division of Vaccine, Vaccine Development Department
ClinicalTrials.gov Identifier:	NCT00655148 History of Changes
Other Study ID Numbers:	VIPV-03
Study First Received:	April 3, 2008
Last Updated:	August 2, 2010
Health Authority:	Poland: Ministry of Health

Keywords provided by Statens Serum Institut:

DTaP-IPV
Clinical Trial
Safety
Immunogenicity

ClinicalTrials.gov processed this record on February 09, 2012