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

Active Immunization Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655148
• Other study ID #: VIPV-03
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2008
• Last updated: January 18, 2013
• Start date: September 2003
• Est. completion date: October 2006

Study information

• Verified date: January 2013
• Source: Statens Serum Institut
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 817
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 49 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Active Immunization

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Poland	Centre Bydgoszcz	Bydgoszcz
Poland	Centre Krakow	Krakow
Poland	Centre Lodz	Lodz
Poland	Centre Poznan	Poznan
Poland	Centre Wroclaw	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Statens Serum Institut

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No