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Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

NCT01106092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2019-10-01

Study results available
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Summary

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Conditions

  • Haemophilus Influenzae Type b
  • Tetanus
  • Hepatitis B
  • Whole Cell Pertussis
  • Diphtheria
  • Poliomyelitis Vaccines

Interventions

BIOLOGICAL

GSK2036874A vaccine

Intramuscular, single dose

BIOLOGICAL

Zilbrix™/Hib vaccine

Intramuscular, single dose

BIOLOGICAL

Poliorix™

Intramuscular, single dose

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-13
Primary Completion
2010-09-02
Completion
2010-09-02

Countries

  • Philippines

Study Locations

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Entities

Diseases
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 NCT01106092 on ClinicalTrials.gov