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Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children

NCT01323972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2018-08-17

Study results available
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Summary

The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)

4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
17 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-16
Primary Completion
2011-11-22
Completion
2012-05-04

Countries

  • Nigeria

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 NCT01323972 on ClinicalTrials.gov