GlaxoSmithKline: Malaria trials

The registry lists 41 Malaria studies with GlaxoSmithKline as lead sponsor. 3 are open to participants now and 23 have results posted.

Phase 1 11Phase 2 18Phase 3 6Phase 4 1No phase 5(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy AdultsRecruitingNCT07646353Phase 1
• A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum MalariaRecruitingNCT07545681Phase 2
• A Study to Assess the Safety and Immunogenicity of a Vaccine Against Malaria in Healthy Children Aged 5-60 MonthsRecruitingNCT07036159Phase 2
• A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve AdultsCompletedNCT03824236Phase 2Results posted
• Study to Assess the Vaccine Efficacy Against Malaria Infection, in Children Immunized With the Primary and Yearly Booster of the RTS,S/AS01E Vaccine, as Part of Their Participation in the Malaria-094 (204889/NCT03276962) Study.CompletedNCT03281291Results posted
• Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of AgeCompletedNCT03276962Phase 2Results posted
• Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve AdultsCompletedNCT03162614Phase 2Results posted
• Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.CompletedNCT02699099Phase 3Results posted
• A Surveillance Study of Diseases Specified as Adverse Events of Special Interest, of Other Adverse Events Leading to Hospitalisation or Death, and of Meningitis in Children in Africa Prior to Implementation of the RTS,S/AS01E Candidate VaccineCompletedNCT02374450Results posted
• Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan AfricaCompletedNCT02251704Phase 4Results posted
• 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 AfricaCompletedNCT02207816Phase 3Results posted
• Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan AfricaCompletedNCT01954264Not applicableResults posted
• Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve AdultsCompletedNCT01857869Phase 2Results posted
• Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve AdultsCompletedNCT01366534Phase 2Results posted
• Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)CompletedNCT01345240Phase 3Results posted
• Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in ChildrenCompletedNCT01323972Phase 3Results posted
• Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African InfantsCompletedNCT01231503Phase 2Results posted
• Epidemiology Study of Malaria Transmission Intensity in AfricaCompletedNCT01190202Not applicableResults posted
• Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and ChildrenCompletedNCT01148459Phase 3Results posted
• Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in AfricaCompletedNCT00866619Phase 3Results posted
• Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI RegimenCompletedNCT00436007Phase 2Results posted
• Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.CompletedNCT00380393Phase 2Results posted
• Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian ChildrenCompletedNCT00360230Phase 2Results posted
• Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 VaccineCompletedNCT00323622Phase 2Results posted
• Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian InfantsCompletedNCT00289185Phase 2Results posted
• Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic RegionCompletedNCT00197028Phase 2Results posted
• A Study Assessing the Safety, Efficacy, and Impact of GlaxoSmithKline Biologicals' RTS, S/AS01E Malaria Vaccine in Young Children Across Sub-Saharan AfricaCompletedNCT03855995
• A Study to Assess the Effects of Dissolution Profile on the Pharmacokinetics of Single Oral Doses of Tafenoquine Tablets and Tafenoquine Stable Isotope Labelled SolutionCompletedNCT02751294Phase 1
• A Microdose Study in Healthy Subjects to Describe Intravenous Pharmacokinetics of GSK3191607CompletedNCT02737007Phase 1
• Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)CompletedNCT02658435Phase 1
• A Study to Evaluate the Pharmacokinetics of a Single Dose of Tafenoquine Co-administered With Either Artemether + Lumefantrine or Dihydroartemisinin + Piperaquine TetraphosphateCompletedNCT02184637Phase 1
• Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone SuspensionCompletedNCT01858831Phase 1
• G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)CompletedNCT01205178Phase 1
• Tafenoquine/Chloroquine DDI StudyCompletedNCT00871156Phase 1
• A First Time in Human Study in Healthy Volunteers to Investigate a New Medicine to Treat MalariaTerminatedNCT00811356Phase 1
• Single-Blind, Placebo-Controlled, Randomized Study Testing Single Ascending Doses Of GSK369796 In Healthy SubjectsCompletedNCT00675064Phase 1
• Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum MalariaCompletedNCT00519467Phase 2
• Characterisation of the Immune Responses of 2 Experimental Malaria VaccinesCompletedNCT00443131Phase 2
• Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese ChildrenCompletedNCT00307021Phase 2
• 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.CompletedNCT00197067Phase 1
• 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.CompletedNCT00197041Phase 2