Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
Status and phase
Completed
Phase 2
Conditions
Malaria
Treatments
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Drug: sulfadoxine-pyrimethamine
Biological: Prevnar™
Biological: Engerix™-B
Biological: Hiberix®
Drug: amodiaquine
Details and patient eligibility
About
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.
Enrollment
1,737 patients
Sex
All
Ages
33 to 69 months old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
1,737 participants in 8 patient groups
Cohort 1-RTS,S/AS02A <24M Group
Experimental group
Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Treatment:
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Cohort 1-RTS,S/AS02A ≥24M Group
Experimental group
Description:
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Treatment:
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Cohort 2-RTS,S/AS02A <24M Group
Experimental group
Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Treatment:
Drug: sulfadoxine-pyrimethamine
Drug: amodiaquine
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Cohort 2-RTS,S/AS02A ≥24M Group
Experimental group
Description:
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Treatment:
Drug: sulfadoxine-pyrimethamine
Drug: amodiaquine
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Cohort 1-Prevnar-Hiberix <24M Group
Active Comparator group
Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Treatment:
Biological: Hiberix®
Biological: Prevnar™
Cohort 1-Engerix-B ≥24M Group
Active Comparator group
Description:
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Treatment:
Biological: Engerix™-B
Cohort 2-Prevnar- Hiberix <24M Group
Active Comparator group
Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Treatment:
Biological: Hiberix®
Drug: sulfadoxine-pyrimethamine
Biological: Prevnar™
Drug: amodiaquine
Cohort 2-Engerix-B ≥24M Group
Active Comparator group
Description:
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Treatment:
Drug: sulfadoxine-pyrimethamine
Biological: Engerix™-B
Drug: amodiaquine
Trial contacts and locations
1
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