Clinical trial NCT02207816: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Infants
Efficacy
Children
Malaria
Plasmodium falciparum
Safety
Surveillance
Immunogenicity
RTS,S/AS01E
Africa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-08-04
Enrollment: 3084
Sex: ALL
Minimum age (years): 42
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subjects' parent(s)/ Legally Acceptable Representative (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Subjects who were enrolled and who received at least one vaccine dose in the primary study MALARIA-055 PRI NCT00866619 and who did not withdraw consent (except those who moved away from the area) during the primary study MALARIA-055 PRI NCT00866619.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product or planned use during the study period.

Primary outcomes:
measure: Incidence of Severe Malaria Meeting Case Definition 1
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Incidence of Severe Malaria Meeting Case Definition 2.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
Secondary outcomes:
measure: Incidence of Clinical Malaria Meeting Case Definition
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Prevalent Parasitemia
timeFrame: At Years 1, 2 and 3
measure: Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)
timeFrame: At Years 1, 2 and 3
measure: Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)
timeFrame: At Years 1, 2 and 3
measure: Incidence of Severe Malaria Meeting Case Definition 1.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
measure: Incidence of Severe Malaria Meeting Case Definition 2.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
measure: Incidence of Clinical Malaria Meeting Case Definition
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)
measure: Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
measure: Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 1.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 2.
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Cerebral Malaria
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 1.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
measure: Number of Subjects With Fatal Malaria Meeting Case Definition 2.
timeFrame: From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).
measure: Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Number of Subjects With Meningitis SAEs
timeFrame: From Year 0 to Year 3 (Starting January 2014 and ending December 2016)
measure: Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)
timeFrame: At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: GSK Investigational Site
city: Kisumu
country: Kenya
facility: GSK Investigational Site
city: Tanga
country: Tanzania
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.