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Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

NCT00635128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2018-06-06

Study results available
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Summary

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

Conditions

  • Poliomyelitis
  • Diphtheria
  • Tetanus
  • Acellular Pertussis

Interventions

BIOLOGICAL

Boostrix-Polio

A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-01
Primary Completion
2008-07-08
Completion
2008-07-08

Countries

  • Germany

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 NCT00635128 on ClinicalTrials.gov