Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine - Tabular View

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Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine

This study has been completed.

Study NCT00148941. Last updated on October 9, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine

Official Title ^†

Safety, Immunogenicity&Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine vs Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Admd as Booster Doses to Healthy Children 4-6 Yrs, Each co-Admd With Merck's MMR Vaccine

Brief Summary

"The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator."

Detailed Description

Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.
Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections.
Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit.
A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Lot-to-lot consistency: immunogenicity one month post-vaccination:
Anti-D antibody concentrations, anti-T antibody concentrations, anti-PT antibody concentrations, anti-FHA antibody concentrations, anti-PRN antibody concentrations, anti-poliovirus type 1, type 2 and type 3 antibody titers.
Non-inferiority: immunogenicity one month post-vaccination:
Anti-D booster response, anti-T booster response, anti-PT booster response, anti-FHA booster response, anti-PRN booster response, anti-poliovirus type 1, type 2 and type 3 antibody titers
Safety:
incidence of increased circumferential swelling at the DTaP-containing vaccine injection site within 4 days after vaccination.

Secondary Outcome Measure ^†

Immunogenicity one month after vaccination:
Anti-D antibody concentration, anti-T antibody concentration, anti-PT antibody concentration, anti-FHA antibody concentration, anti-PRN antibody concentration, anti-poliovirus type 1, type 2 and type 3 booster response
Safety:
Safety and reactogenicity of the study vaccines in all groups during the entire study period

Condition ^†

Prophylaxis
Diphtheria
Tetanus
Pertussis
Poliomyelitis

Intervention ^†

Biological: Diphtheria, tetanus, pertussis, poliovirus type 1, 2 & 3

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

4200

Start Date ^†

January 2005

Completion Date

Eligibility Criteria ^†

Inclusion criteria:

Healthy male or female child between and including 4 and 6 years of age at the time of vaccination.
Subjects should have received 4 doses of GSK DTaP (primary vaccination course with booster dose in the second year of life) and 3 doses of IPV during the first 2 years of life and vaccination against measles, mumps, and rubella in the second year of life.

Exclusion criteria:

Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period.
Administration of immunoglobulins and/or blood products within 3 months prior to vaccination or planned administration during the study period.

Gender

Both

Ages

4 Years to 6 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00148941

Organization ID

213503/048

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

September 7, 2005

Last Updated Date

October 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.