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

NCT00655148 | Completed Phase 3

• 1 other identifier: VIPV-03
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Active Immunization

Keywords

DTaP-IPV; Clinical Trial; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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

  One month after the third vaccination

Study Arms (2)

A

EXPERIMENTAL

DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age

Biological: DTaP-IPV vero vaccine

B

ACTIVE COMPARATOR

DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age

Biological: DTaP-IPV mkc vaccine

Interventions

DTaP-IPV vero vaccine BIOLOGICAL

DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age

A

DTaP-IPV mkc vaccine BIOLOGICAL

DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age

B

Eligibility Criteria

• Age: 28 Days - 49 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Statens Serum Institut: lead

Study Sites (5)

Centre Bydgoszcz

Bydgoszcz, Poland

Location

Centre Krakow

Krakow, Poland

Location

Centre Lodz

Lodz, Poland

Location

Centre Poznan

Poznan, Poland

Location

Centre Wroclaw

Wroclaw, Poland

Location

Study Officials

• Jacek Pietrzyk, Proffessor M.D.

  Jagellonian University, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: September 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

PL (5)