Phase 3
Completed N=3,084
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
Source: ClinicalTrials.gov NCT02207816 ↗Enrolled (actual)
3,084
Serious AEs
4.3%
Results posted
Aug 2019
Primary outcomePrimary: Incidence of Severe Malaria Meeting Case Definition 1 — 0.001; 0.002; 0.002; 0.004 events per person-year — p=0.2235
◆ Published Evidence
Established
70citations · ~10 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Severe Malaria Meeting Case Definition 1 |
0.001; 0.002; 0.002; 0.004; 0.003; 0.005 | 0.2235 |
| PRIMARY Incidence of Severe Malaria Meeting Case Definition 2. |
0.015; 0.021; 0.023; 0.019; 0.019; 0.028 | 0.0028 sig |
| SECONDARY Incidence of Clinical Malaria Meeting Case Definition |
1.277; 1.348; 1.555; 1.662; 1.723; 1.921 | <.0001 sig |
| SECONDARY Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. |
61; 82; 94; 52; 60; 73 | 0.0053 sig |
| SECONDARY Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. |
60; 79; 93; 54; 60; 75 | 0.0051 sig |
| SECONDARY Number of Subjects With Prevalent Parasitemia |
52; 46; 89; 48; 65; 61 | <0.0001 sig |
| SECONDARY Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL) |
0; 0; 0; 0; 0; 0 | 0.4987 |
| SECONDARY Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL) |
7; 9; 2; 16; 6; 11 | 0.1025 |
| SECONDARY Incidence of Severe Malaria Meeting Case Definition 1. |
0.009; 0.016; 0.015; 0.014; 0.013; 0.02 | 0.0077 sig |
| SECONDARY Incidence of Severe Malaria Meeting Case Definition 2. |
0.015; 0.021; 0.023; 0.019; 0.019; 0.028 | 0.0028 sig |
| SECONDARY Incidence of Clinical Malaria Meeting Case Definition |
1.277; 1.348; 1.555; 1.662; 1.723; 1.921 | <.0001 sig |
| SECONDARY Number of Subjects With Malaria Hospitalization Meeting Case Definition 1. |
61; 82; 94; 52; 60; 73 | 0.0053 sig |
| SECONDARY Number of Subjects With Malaria Hospitalization Meeting Case Definition 2. |
60; 79; 93; 54; 60; 75 | 0.0051 sig |
| SECONDARY Number of Subjects With Cerebral Malaria Meeting Both Case Definitions. |
0; 2; 0; 1; 0; 0 | — |
| SECONDARY Number of Subjects With Fatal Malaria Meeting Case Definition 1. |
2; 4; 1; 1; 2; 0 | 1.0000 |
| SECONDARY Number of Subjects With Fatal Malaria Meeting Case Definition 2. |
5; 7; 4; 4; 6; 1 | 1.0000 |
| SECONDARY Number of Subjects With Cerebral Malaria |
4; 10; 2; 3; 2; 0 | 0.6869 |
| SECONDARY Number of Subjects With Fatal Malaria Meeting Case Definition 1. |
2; 4; 1; 1; 2; 0 | 1.0000 |
| SECONDARY Number of Subjects With Fatal Malaria Meeting Case Definition 2. |
5; 7; 4; 4; 6; 1 | 1.0000 |
| SECONDARY Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs) |
20; 25; 27; 19; 18; 25 | — |
| SECONDARY Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Meningitis SAEs |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS) |
671.8; 599.3; 0.3; 152.9; 169.0; 0.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02207816) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.