Phase 2
Completed N=1,737
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Source: ClinicalTrials.gov NCT00323622 ↗Enrolled (actual)
1,737
Serious AEs
5.6%
Results posted
Mar 2014
Primary outcomePrimary: Number of Subjects With Serious Adverse Events (SAEs) — 21; 17; 1; 0 Subjects
Summary
The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1.
This protocol posting deals with objectives & outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
21; 17; 1; 0; 24; 29 | — |
| SECONDARY Anti-circumsporozoite Protein (CS) Antibody Concentrations. |
10.1; NA; 16.2; 0.6; 8.9; NA | — |
| SECONDARY Anti-hepatitis B (HBs) Antibody Concentrations. |
4008.6; 1842.5; 20.3; 67.4; 3323.8; 1557.0 | — |
| SECONDARY Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition |
0.330; 0.375; 0.140; 0.149 | 0.08 |
| SECONDARY Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1 |
0.365; 0.409; 0.161; 0.174 | 0.11 |
| SECONDARY Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2 |
0.540; 0.630; 0.260; 0.270 | 0.01 sig |
| SECONDARY Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3 |
0.288; 0.329; 0.122; 0.122 | 0.10 |
| SECONDARY Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) |
252; 291; 99; 100 | — |
| SECONDARY Number of Subjects With Anemia. |
2; 2; 584; 593; 64; 50 | — |
| SECONDARY Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia |
93; 121; 66; 101 | — |
Eligibility Criteria
Inclusion criteria
- Completion of Visit 7, Month 21 of 104297 (NCT= NCT00197041).
- Written informed consent obtained from the parent(s) or guardian(s) of the subject
Exclusion criteria
- Planned use of any investigational or non-registered drug or vaccine during the study period.
- Simultaneous participation in any other clinical trial
Data sourced from ClinicalTrials.gov (NCT00323622). 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.