Assess Immunogenicity, Reactogenicity of GSK Biologicals'-dTpa-IPV Vaccine Versus dTpa & IPV Vaccines Administered Separately & Compared With Aventis Pasteur MSD's Td-IPV Vaccine When Administered to Healthy Adolescents & Adults

GlaxoSmithKline0 sites806 target enrollmentJanuary 2002

ConditionsTetanus Diphtheria Acellular Pertussis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Tetanus
Sponsor: GlaxoSmithKline
Enrollment: 806
Primary Endpoint: Immunogenicity with respect to components of the study vaccines
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study will assess the immunogenicity and reactogenicity of the candidate GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine when administered to healthy subjects aged ≥ 15 years in Germany and ≥ 18 years in France compared to Boostrix™ and inactivated poliovirus vaccine administered separately, and with Revaxis®

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

April 2002

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A male or female subjects aged 15 years and over (Germany), or 18 years and over (France) at the time of the vaccination.
•Written informed consent obtained.
•Free of obvious health problems Having received primary vaccination with diphtheria and tetanus vaccines to the best of his/her knowledge.
•Female subjects must not be pregnant or lactating.

Exclusion Criteria

•Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
•History of previous or intercurrent diphtheria or tetanus, pertussis or polio disease in the last 10 years.
•French subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
•German subjects: history of diphtheria or tetanus, pertussis or polio vaccination in the last 5 years, except those subjects participating in the tetanus antibody kinetic subgroup.
•German subjects participating in the tetanus antibody kinetic subgroup: history of diphtheria or tetanus, pertussis or polio vaccination in the last 10 years.
•Administration or planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the study vaccine dose and ending 30 days after study vaccination.
•Chronic administration or planned administration of immuno-suppressants or other immune-modifying drugs within six months or 5 half-lives (whichever is the longer) of vaccination.
•Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
•Any confirmed or suspected immunosuppressive or immunodeficient condition,
•History of seizures or progressive neurological disease.

Outcomes

Primary Outcomes

Immunogenicity with respect to components of the study vaccines

Time Frame: One month after vaccination (Month 1)

Secondary Outcomes

Immunogenicity with respect to components of the study vaccines(One month after vaccination (Month 1))
Immunogenicity with respect to some component of the study vaccines(At Day 10 after vaccination)
Occurrence of serious adverse events(Throughout the entire study (from Day 0 to Day 30))
Occurrence of solicited local and general symptoms(within 15 (Day 0-14) days after vaccination)
Occurrence of unsolicited symptoms(within 30 days (Day 0-29) after vaccination)