Clinical trials: in The Gambia
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
RSV Infection
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the…
- Trial name
- NCT06866405
- Testing
- RSVpreF
- Where
- 97 sites in United States, Argentina and 2 more
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Pfizer
Preeclampsia
Optimizing the Use of Aspirin for the Prevention of Preeclampsia
Pregnant women at higher risk for preeclampsia (PE) are currently recommended to take low-dose aspirin (acetylsalicylic acid, ASA) daily from the first trimester until 36 weeks of gestation.
- Trial name
- Optim-PRE (NCT07665853)
- Testing
- Discontinuation of Acetylsalicilic acid 150 mg/day at 24-28 weeks of gestation
- Where
- 38 sites in Austria, Bulgaria and 5 more
- Volunteers
- 15,160 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Meningoccocal Disease
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.
- Trial name
- PERS-ACYWX-03 (NCT07379151)
- Where
- 2 sites in Mali, The Gambia
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
RSV Infections, RSV Immunisation
A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.
Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too…
- Conditions
- RSV Infections, RSV Immunisation, Preterm Labour
- Trial name
- NCT06955728
- Testing
- Vaccine
- Where
- 11 sites in Ghana, Kenya and 2 more
- Volunteers
- 13,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Malaria, Plasmodium Falciparum
A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage…
- Trial name
- NCT05357560
- Testing
- Matrix-M with RH5.2 VLP and/or R21
- Where
- The Gambia
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Preterm Infant, Hypothermia, Newborn
Early Kangaroo Mother Care in Gambian Hospitalised Unstable Neonates
The mortality effect of kangaroo mother care in stable newborns <2000g is well established but mortality effect in unstable newborns is not conclusively known.
- Conditions
- Preterm Infant, Hypothermia, Newborn, Death, Kangaroo Mother Care
- Trial name
- eKMC (NCT03555981)
- Testing
- Early Kangaroo Mother Care, Standard care
- Where
- The Gambia
- Volunteers
- 279 people
- Sponsor
- London School of Hygiene and Tropical Medicine
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
Scabies
Ivermectin Safety in Small Children
This trial will evaluate the safety, pharmacokinetics, and efficacy of ivermectin in scabies infected children weighing 5 to less than 15kg.
- Trial name
- ISSC (NCT04332068)
- Testing
- Oral ivermectin, Permethrin Cream
- Where
- 3 sites in Brazil, Kenya and 1 more
- Volunteers
- 240 people
- Sponsor
- University of Oxford
Plasmodium Falciparum Malaria (Uncomplicated)
A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.
A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine+amodiaquine (AL+AQ) and artesunate-mefloquine+piperaquine (ASMQ+PPQ) and the…
- Trial name
- DeTACT-Africa (NCT03923725)
- Testing
- Artemether-lumefantrine+ Amodiaquine (AL+AQ), Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)
- Where
- 8 sites in Burkina Faso, Democratic Republic of the Congo and 6 more
- Volunteers
- 2,583 people
- Sponsor
- University of Oxford
Tuberculosis (TB)
A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC.
- Trial name
- NAC-PTLD (NCT06909799)
- Testing
- N-Acetyl Cysteine (NAC), Standard TB treatment
- Where
- The Gambia
- Volunteers
- 242 people
- Sponsor
- The Aurum Institute NPC
Respiratory Tract Infection
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in…
- Trial name
- NCT04424316
- Testing
- RSVpreF
- Where
- 464 sites in United States, Argentina and 16 more
- Volunteers
- 14,727 people, healthy volunteers welcome
- Sponsor
- Pfizer
Shigella, Child
Enterics for Global Health (EFGH)
Diarrhea remains a leading cause of death among young children, with the majority of diarrhea deaths occurring in low- and middle-income countries.
- Conditions
- Shigella, Child, Diarrhea
- Trial name
- EFGH (NCT06047821)
- Where
- 33 sites in Bangladesh, Kenya and 5 more
- Volunteers
- 9,800 people
- Sponsor
- University of Washington
Tuberculosis, Pulmonary
Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden
The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a…
- Trial name
- NCT05190146
- Where
- 36 sites in Bangladesh, Brazil and 12 more
- Volunteers
- 7,203 people, healthy volunteers welcome
- Sponsor
- Gates Medical Research Institute
Malaria
Cluster Randomized Trial of Peer Health Education in Malaria in The Gambia
Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health.
- Trial name
- NCT00269178
- Testing
- Peer Health Education Programme
- Where
- The Gambia
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Malaria
Seasonal R21 Mass Vaccination for Malaria Elimination
This is a cluster randomized trial to determine the impact of seasonal R21/MM mass vaccination (all ages) on malaria transmission and morbidity.
- Trial name
- SERVAL (NCT06578572)
- Testing
- R21Matrix M
- Where
- 2 sites in Burkina Faso, The Gambia
- Volunteers
- 16,200 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Hiv, Syphilis
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple…
- Conditions
- Hiv, Syphilis, HBV
- Trial name
- TRI-MOM (NCT05951751)
- Testing
- TRI-MOM intervention
- Where
- 2 sites in Burkina Faso, The Gambia
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
Newborn Vaccine Immunogenicity
Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity
Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use.
- Trial name
- EPIC-HIPC (NCT03246230)
- Testing
- Hepatitis B vaccine (HBV), Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in Papua New Guinea, The Gambia
- Volunteers
- 911 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Yellow Fever
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV…
- Trial name
- NCT05447377
- Testing
- SII Yellow Fever Vaccine, STAMARIL®
- Where
- 2 sites in Mali, The Gambia
- Volunteers
- 2,216 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.