Clinical trials: Falciparum Malaria
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
Uncomplicated Plasmodium Falciparum Malaria
Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria
This study aimed to confirm the efficacy, safety and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF), when administered once daily for…
- Trial name
- KALUMA (NCT05842954)
- Testing
- KLU156, Coartem
- Where
- 32 sites in Burkina Faso, Côte d’Ivoire and 10 more
- Volunteers
- 1,720 people
- Sponsor
- Novartis Pharmaceuticals
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, 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
Falciparum Malaria
Efficacy of ArTiMist™ in Children
The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with…
- Trial name
- NCT01047436
- Testing
- Quinine, Artemether
- Volunteers
- 31 people
- Sponsor
- Proto Pharma Ltd
Acute Uncomplicated Falciparum Malaria
Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
- Trial name
- NCT01619878
- Testing
- Artemether-lumefantrine (COA566)
- Where
- 7 sites in Benin, Burkina Faso and 3 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model
The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum…
- Trial name
- NCT04250363
- Testing
- PfSPZ Challenge, Palcebo, M5717 30 mg
- Where
- Netherlands
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Plasmodium Falciparum Malaria
Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe…
- Trial name
- NCT01258049
- Testing
- Artemether Sublingual Spray, Quinine
- Where
- 3 sites in Burkina Faso, Ghana and 1 more
- Volunteers
- 151 people
- Sponsor
- Proto Pharma Ltd
Malaria, Falciparum
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P.
- Trial name
- NCT00677833
- Testing
- Azithromycin plus Chloroquine, Artemether-lumefantrine
- Where
- 7 sites in Burkina Faso, Côte d’Ivoire and 3 more
- Volunteers
- 361 people
- Sponsor
- Pfizer
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
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P.
- Trial name
- NCT01256658
- Testing
- COA566
- Where
- 3 sites in Burkina Faso
- Volunteers
- 14,075 people
- Sponsor
- Novartis
Malaria
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400 mg/day (Part 1) and single dosing with KAF156 at…
- Trial name
- NCT01753323
- Testing
- KAF156
- Where
- 5 sites in Thailand, Vietnam
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria…
- Trial name
- NCT03334747
- Testing
- KAE609, Coartem
- Where
- 9 sites in Gabon, Ghana and 3 more
- Volunteers
- 188 people
- Sponsor
- Novartis Pharmaceuticals
Malaria
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609
- Trial name
- NCT01836458
- Testing
- KAE609
- Where
- Vietnam
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
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 Infection
Efficacy, Safety, and PK of M5717 in Combination With Pyronaridine as Chemoprevention in Adults and Adolescents With Asymptomatic Plasmodium Falciparum Infection (CAPTURE-2)
This study evaluates the efficacy and safety of a single dose of M5717 plus pyronaridine tetraphosphate in clearing current Plasmodium falciparum infection and protecting against recurrent infections in asymptomatic adults and…
- Trial name
- NCT05974267
- Testing
- M5717 60 mg, Pyronaridine, Atovaquone-Proguanil
- Where
- 4 sites in Burkina Faso, Kenya and 2 more
- Volunteers
- 192 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
Acute Uncomplicated Plasmodium Falciparum Malaria
Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in…
- Trial name
- NCT03167242
- Testing
- KAF156, Coartem, Lumefantrine Solid Dispersion Formulation
- Where
- 11 sites in Burkina Faso, Gabon and 7 more
- Volunteers
- 524 people
- Sponsor
- Novartis Pharmaceuticals
Cure Rate
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day
- Trial name
- NCT01860989
- Testing
- KAE609
- Where
- 4 sites in Thailand, Vietnam
- Volunteers
- 11 people
- Sponsor
- Novartis Pharmaceuticals