MedTrace Logo

Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

NCT01245049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2018-08-17

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Conditions

  • Acellular Pertussis
  • Poliomyelitis
  • Tetanus
  • Diphtheria

Interventions

BIOLOGICAL

Boostrix PolioTM

Single dose, intramuscular administration.

BIOLOGICAL

RepevaxTM

Single dose, intramuscular administration.

BIOLOGICAL

PriorixTM

Single dose, intramuscular or subcutaneous administration.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-01
Primary Completion
2012-03-27
Completion
2012-04-02

Countries

  • United Kingdom

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 NCT01245049 on ClinicalTrials.gov