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
NCT ID: NCT02207816
Last Updated: 2019-11-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
3084 participants
INTERVENTIONAL
2014-09-18
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
NCT00197067
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
NCT00323622
A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, When Administered to Children Aged 1 to 4 Years Living in a Malaria-endemic Region of Mozambique.
NCT00197041
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
NCT00307021
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
NCT01231503
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GSK257049 Group
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.
Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
Malaria Vaccine 257049 (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
TritanrixHepB/Hib (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Administered orally, during the MALARIA-055 study (NCT00866619).
GSK257049 Comparator Group
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.
Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
Malaria Vaccine 257049 (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
TritanrixHepB/Hib (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Administered orally, during the MALARIA-055 study (NCT00866619).
VeroRab/Menjugate Comparator Group
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.
Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Cell-culture rabies vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
TritanrixHepB/Hib (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Administered orally, during the MALARIA-055 study (NCT00866619).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sampling
Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
Malaria Vaccine 257049 (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Cell-culture rabies vaccine (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
TritanrixHepB/Hib (MALARIA-055 PRI)
Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)
Administered orally, during the MALARIA-055 study (NCT00866619).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Use of any investigational or non-registered product or planned use during the study period.
42 Months
9 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Ouagadougou, , Burkina Faso
GSK Investigational Site
Kisumu, , Kenya
GSK Investigational Site
Tanga, , Tanzania
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200599
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.