Clinical trials: Malaria Vaccines
Malaria
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first…
- Trial name
- NCT00436007
- Testing
- GSK 257049, Tritanrix™ HepB/Hib, Rouvax™
- Where
- 3 sites in Gabon, Ghana and 1 more
- Volunteers
- 511 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
- Trial name
- NCT01148459
- Testing
- GSK Biological's Investigational Malaria Vaccine 257049, Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);, Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).
- Where
- 2 sites in Kenya
- Volunteers
- 200 people
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
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 Vaccine
The purpose of this pre-licensure cohort study was to estimate the incidence of adverse events of special interest (AESI), other adverse events (AE) leading to hospitalisation or death, meningitis and malaria in sub-Saharan…
- Trial name
- NCT02374450
- Testing
- Blood collection
- Where
- 5 sites in Burkina Faso, Ghana and 1 more
- Volunteers
- 36,366 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00289185
- Testing
- RTS,S/AS02D, Engerix-B®, TETRActHib™
- Where
- Tanzania
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region
GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in…
- Trial name
- NCT00197028
- Testing
- RTS,S/AS02D, TETRActHib™, Engerix-B®
- Where
- Mozambique
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine
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…
- Trial name
- NCT00323622
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix™-B, Hiberix®
- Where
- Mozambique
- Volunteers
- 1,737 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children.
- Trial name
- NCT00360230
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Rabipur
- Where
- 2 sites in Ghana
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria,Falciparum
PfSPZ Vaccine Trial in Malian Children
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of…
- Trial name
- NCT04940130
- Testing
- Sanaria® PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Malaria
Safety and Immunogenicity of GSK Biologicals' Malaria Vaccine 257049 When Administered on 7 Schedules to African Infants
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO.
- Trial name
- NCT01231503
- Testing
- GSK Biological's Investigational Malaria Vaccine 257049, Engerix-B, Tritanrix HepB Hib
- Where
- Malawi
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP)…
- Trial name
- NCT05581641
- Testing
- BNT165b1
- Where
- 5 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria, Malaria Vaccines
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.
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6…
- Trial name
- NCT02699099
- Testing
- Vitamin A, Candidate Plasmodium falciparum malaria vaccine, MR-Vac
- Where
- 2 sites in Ghana
- Volunteers
- 699 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy…
- Trial name
- NCT03162614
- Testing
- RTS,S/AS01E, RTS,S/AS01B, Sporozoite-infected mosquitoes challenge.
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Consistency of Immunogenicity and Non Inferiority of GSK Biologicals' Candidate Malaria Vaccine Lots in Children
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
- Trial name
- NCT01323972
- Testing
- GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)
- Where
- 2 sites in Nigeria
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
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 Adults
MALARIA-092 (NCT03162614) study was designed to evaluate the efficacy, immunogenicity and safety of various dose schedules and formulations of GSK Biologicals' candidate malaria vaccine (RTS,S/AS01E) in healthy malaria-naïve…
- Trial name
- NCT03824236
- Testing
- RTS,S/AS01E (SB257049)
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
- Trial name
- NCT02013687
- Testing
- Pfs25 VLP- FhCMB
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Malaria
Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve Adults
This study is designed to evaluate safety, reactogenicity, immunogenicity, and efficacy of GSK Biological's malaria candidate vaccine 257049 administered as standard doses at 0 and 1 months and 1/5th standard dose at 7 months…
- Trial name
- NCT01857869
- Testing
- GSK257049 Dosage 1, GSK257049 Dosage 2, Sporozoite-infected mosquitoes challenge
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
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
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…
- Trial name
- NCT02207816
- Testing
- Blood sampling, Malaria Vaccine 257049 (MALARIA-055 PRI), Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)
- Where
- 3 sites in Burkina Faso, Kenya and 1 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
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 Age
The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination.
- Trial name
- NCT03276962
- Testing
- RTS,S/AS01E (Full dose), RTS,S/AS01E (1/5th dose), Rabies vaccine
- Where
- 2 sites in Ghana, Kenya
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa
The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.
- Trial name
- NCT00866619
- Testing
- Malaria Vaccine 257049, Meningococcal C Conjugate Vaccine, Cell-culture rabies vaccine
- Where
- 10 sites in Burkina Faso, Gabon and 5 more
- Volunteers
- 15,459 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline