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Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants

NCT01231503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-08-15

Study results available
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Summary

The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to:

* Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen.
* Investigate how to maximize the antibody response to the experimental malaria vaccine.

Conditions

Interventions

BIOLOGICAL

GSK Biological's Investigational Malaria Vaccine 257049

3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age

BIOLOGICAL

Engerix-B

1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)

BIOLOGICAL

Tritanrix HepB Hib

3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age

BIOLOGICAL

BCG

1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)

BIOLOGICAL

OPV

4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age

BIOLOGICAL

Rouvax

1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-13
Primary Completion
2014-04-30
Completion
2014-12-23

Countries

  • Malawi

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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 NCT01231503 on ClinicalTrials.gov