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Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

NCT00544271 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2016-09-07

No results posted yet for this study

Summary

To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Conditions

  • Acellular Pertussis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

INFANRIX

BIOLOGICAL

BOOSTRIX

BIOLOGICAL

HAVRIX

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
20 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Completion
2004-01-31

Countries

  • Australia

Study Locations

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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 NCT00544271 on ClinicalTrials.gov