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

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.

Timeline

Start

2014-09-18

Primary completion

2017-01-31

Completion

2017-01-31

Outcome

Missed primary endpoint

registry analysis (superiority test); GSK257049 [5-17M] Group vs VeroRab Comparator [5-17M] Group; p = 0.2235; Vaccine efficacy 74.38 (95% CI -130 to 97.14) NCT02207816 ↗

registry analysis (superiority test); GSK257049 [5-17M] Group vs VeroRab Comparator [5-17M] Group; p = 0.0930; Vaccine efficacy 53.68 (95% CI -13.7 to 81.13) NCT02207816 ↗

Publications

• Background Tinto H, Otieno W, Gesase S, Sorgho H, Otieno L, Liheluka E, Valea I, Sing'oei V, Malabeja A, Valia D, Wangwe A, Gvozdenovic E, Guerra Mendoza Y, Jongert E, Lievens M, Roman F, Schuerman L, Lusingu J. Long-term incidence of severe malaria following RTS,S/AS01 vaccination in children and infants in Africa: an open-label 3-year extension study of a phase 3 randomised controlled trial. Lancet Infect Dis. 2019 Aug;19(8):821-832. doi: 10.1016/S1473-3099(19)30300-7. Epub 2019 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GSK257049	Vaccine	—	Intramuscular
Comparator	Cell-culture rabies vaccine	Vaccine	—	Intramuscular
Comparator	Meningococcal C conjugate vaccine	Vaccine	—	Intramuscular
Background	Polio Sabin Oral Polio Vaccine	Vaccine	—	Oral
Background	TritanrixHepB/Hib	Vaccine	—	Intramuscular

Indications