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Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)

NCT01294605 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2016-09-15

No results posted yet for this study

Summary

This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.

Conditions

  • Acellular Pertussis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

Boostrix™ (dTpa)

Intramuscular, 3 doses

BIOLOGICAL

GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)

Intramuscular, single dose

BIOLOGICAL

Ditanrix™ Adult, TedivaxTM (Td)

Intramuscular, 2 doses

BIOLOGICAL

Ditanrix™ Adult, TedivaxTM (Td)

Intramuscular, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • Belgium
  • Netherlands
  • Spain

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 NCT01294605 on ClinicalTrials.gov