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Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

NCT01345240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2019-07-18

Study results available
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Summary

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

Conditions

Interventions

BIOLOGICAL

GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.

BIOLOGICAL

Engerix-B™ vaccine

Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.

BIOLOGICAL

Infanrix/Hib™ vaccine

Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection

BIOLOGICAL

Polio Sabin™ vaccine

Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.

BIOLOGICAL

Rotarix™ vaccine

Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.

BIOLOGICAL

Synflorix™ vaccine

Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.

BIOLOGICAL

Measles vaccine

Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.

BIOLOGICAL

Yellow fever vaccine

Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-17
Primary Completion
2013-01-09
Completion
2017-02-09

Countries

  • Burkina Faso
  • Ghana

Study Locations

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Entities

Drugs
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 NCT01345240 on ClinicalTrials.gov