Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards

GlaxoSmithKline0 sites550 target enrollmentSeptember 1997

ConditionsDiphtheria Pertussis Tetanus

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diphtheria
Sponsor: GlaxoSmithKline
Enrollment: 550
Primary Endpoint: Occurrence of solicited local and general symptoms
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.

Registry

clinicaltrials.gov

Start Date

September 1997

End Date

February 1998

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age at the time of the vaccination
•Written informed consent has been obtained

Exclusion Criteria

•Evidence of confirmed pertussis disease within the previous 5 years
•History of diphtheria or tetanus vaccination within the past 5 years Females must not be pregnant or lactating They must either surgically sterilized or one year post-menopausal or if they are of childbearing potential, they must be abstinent or have used adequate contraceptive precautions (or one month prior to the booster vaccination, and must agree to continue such precautions for 2 months after completion of the vaccination.
•History of diphtheria or tetanus disease
•History of allergic disease likely to be stimulated by the vaccination
•Major congenital defects or serious chronic illness
•History of progressive neurological disease
•Immunosuppressive therapy
•Any suspected or confirmed immune disorder
•Immunoglobulin therapy or administration of any blood products within the previous three months or during the study period
•Acute febrile illness (\>37.5°C, axillary or oral temperature) at the time of planned vaccination

Outcomes

Primary Outcomes

Occurrence of solicited local and general symptoms

Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection

Secondary Outcomes

Immunogenicity with respect to components of the study vaccines(2, 3, 4 and 5 years after the vaccination)
Occurrence of solicited local symptoms and fever(Within the 15-day (Day 0 - Day 14) follow-up period after the second injection)
Occurrence of general solicited symptoms to vaccination, other than fever(Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration)
Occurrence of unsolicited symptoms(Within 31 days (Day 0 - Day 30) after each vaccine administration)
Occurrence of serious adverse experiences to vaccination(Within 31 days (Day 0 - Day 30) after each vaccine administration)