MedTrace Logo

Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9

NCT00489970 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1954

Last updated 2020-05-01

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study.

This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).

Conditions

  • Acellular Pertussis
  • Tetanus
  • Diphtheria

Interventions

PROCEDURE

Taking of blood samples

No treatment is planned to be given in this study. Blood samples will be collected at the following time points: 1 year, 3 years, 5 years and 9 years after the dose of vaccination.

BIOLOGICAL

Boostrix

A single dose of Boostrix was administered in the primary study (NCT00346073). No treatment was given in this study.

BIOLOGICAL

Adacel

A single dose of Adacel was administered in the primary study (NCT00346073). No treatment was given in this study.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
73 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-01
Primary Completion
2011-09-01
Completion
2016-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00489970 on ClinicalTrials.gov