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
Status and phase
Completed
Phase 3
Conditions
Malaria
Treatments
Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)
Biological: Cell-culture rabies vaccine (MALARIA-055 PRI)
Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Procedure: Blood sampling
Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Biological: TritanrixHepB/Hib (MALARIA-055 PRI)
Details and patient eligibility
About
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.
Enrollment
3,084 patients
Sex
All
Ages
42 months to 9 years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
3,084 participants in 3 patient groups
GSK257049 Group
Experimental group
Description:
Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on a 0-1-2-month schedule, and a booster dose of GSK257049 malaria vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); left deltoid (GSK257049 booster dose); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
Treatment:
Biological: TritanrixHepB/Hib (MALARIA-055 PRI)
Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Procedure: Blood sampling
Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)
GSK257049 Comparator Group
Active Comparator group
Description:
Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of GSK257049 malaria vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: in the anterolateral left thigh (GSK257049 vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
Treatment:
Biological: TritanrixHepB/Hib (MALARIA-055 PRI)
Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Procedure: Blood sampling
Biological: Malaria Vaccine 257049 (MALARIA-055 PRI)
Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
VeroRab/Menjugate Comparator Group
Active Comparator group
Description:
Male or female infants (between and including 6 to 12 weeks of age)/children (between and including 5 to 17 months of age) received 3 doses of VeroRab vaccine (children subgroup) or Menjugate vaccine (co-administered with Polio Sabin and Tritanrix HepB/Hib vaccines, for the infants subgroup) on 0-1-2-month schedule, and a booster dose of Menjugate vaccine (co-administered with Polio Sabin, for the infants subgroup) at Month 20 during the primary study MALARIA-055 PRI (NCT00866619). Vaccines were administered intramuscularly: left deltoid (VeroRab vaccine and Menjugate vaccine); anterolateral right thigh (Tritanrix HepB/Hib vaccine); orally: Polio Sabin vaccine. No vaccination was administered during this study.
Treatment:
Biological: TritanrixHepB/Hib (MALARIA-055 PRI)
Biological: Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Procedure: Blood sampling
Biological: Cell-culture rabies vaccine (MALARIA-055 PRI)
Biological: Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Trial contacts and locations
3
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Data sourced from clinicaltrials.gov
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