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An Extension to Study MALARIA-055 PRI (NCT00866619) to Evaluate the Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine in Infants and Children in Africa

NCT02207816 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3084

Last updated 2019-11-25

Study results available
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Summary

The purpose of this study is to conduct long-term surveillance for efficacy, safety and immunogenicity of the GSK Biologicals RTS,S/AS01E candidate Plasmodium falciparum malaria vaccine in infants and children in Africa following a primary vaccination series (NCT00866619). No new subjects will be enrolled in this extension study.

Conditions

Interventions

PROCEDURE

Blood sampling

Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.

BIOLOGICAL

Malaria Vaccine 257049 (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

Cell-culture rabies vaccine (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

TritanrixHepB/Hib (MALARIA-055 PRI)

Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).

BIOLOGICAL

Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)

Administered orally, during the MALARIA-055 study (NCT00866619).

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Months
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-18
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Burkina Faso
  • Kenya
  • Tanzania

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 NCT02207816 on ClinicalTrials.gov