CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,084 enrolled
Drug / intervention
Malaria Vaccine 257049 (MALARIA-055 PRI) +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02207816
NCT02207816Phase 3Completed
CompareCT.gov

Extension to Study MALARIA-055 PRI (NCT00866619) for Evaluation of Long-term Efficacy, Safety and Immunogenicity of GSK Biologicals' Candidate Malaria Vaccine (SB257049) in Infants and Children in Africa

GlaxoSmithKline·interventional·Posted Aug 4, 2014·Updated Nov 25, 2019

In Brief

A Phase 3 clinical trial evaluating Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), and 4 other interventions for Malaria. Completed, enrolled 3,084 participants across 3 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesBurkina Faso, Kenya, Tanzania
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartSep 18, 2014
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.9 years ago

Interventions

Blood samplingprocedure

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

Malaria Vaccine 257049 (MALARIA-055 PRI)biological

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

Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)biological

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

Cell-culture rabies vaccine (MALARIA-055 PRI)biological

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

TritanrixHepB/Hib (MALARIA-055 PRI)biological

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

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

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