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Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

NCT01098474 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2019-06-27

Study results available
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Summary

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.

Conditions

Interventions

BIOLOGICAL

GSK's investigational vaccine 692342

Intramuscular, 1 or 2 doses

BIOLOGICAL

Tritanrix™ HB+Hib

Intramuscular, 3 doses

BIOLOGICAL

Prevnar™

Intramuscular, 3 doses

BIOLOGICAL

Polio Sabin™

Oral, 3 doses

BIOLOGICAL

Menjugate™

Intramuscular, 3 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-07
Primary Completion
2011-04-30
Completion
2012-03-16

Countries

  • The Gambia

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 NCT01098474 on ClinicalTrials.gov