Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine - Tabular View

Tracking Information

First Received Date ^ICMJE

April 3, 2008

Last Updated Date

April 3, 2008

Start Date ^ICMJE

September 2003

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Active Immunization

Intervention ^ICMJE

Biological: DTaP-IPV vero vaccine
Biological: DTaP-IPV mkc vaccine

Study Arms / Comparison Groups

Experimental: DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age
Active Comparator: DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

817

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 49 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT ID ^ICMJE

NCT00655148

Responsible Party

Ingrid Kromann, Statens Serum Institut, Division of Vaccine, Vaccine Development Department

Study ID Numbers ^ICMJE

VIPV-03

Study Sponsor ^ICMJE

Statens Serum Institut

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jacek Pietrzyk, Proffessor M.D.

Jagellonian University, Krakow, Poland

Information Provided By

Statens Serum Institut

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP