Clinical trials: sponsored by GlaxoSmithKline
Meningitis
A Phase 3 Study to Assess the Immune Response and Safety of rMenB+OMV NZ in Primed Healthy Participants (10 to 20 Years Old)
The main purpose of this study was to evaluate the immune response and safety of a booster dose of the meningococcal group B vaccine, rMenB+OMV NZ (also known as Bexsero), in adolescents and young adults aged 10 to 20 years.
- Trial name
- NCT06995430
- Testing
- rMenB+OMV NZ vaccine
- Where
- 17 sites in Finland, Italy and 2 more
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN…
- Trial name
- PALISADE (NCT06134362)
- Testing
- CAB LA
- Where
- 33 sites in Argentina, Botswana and 10 more
- Volunteers
- 2,998 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Diarrhoea
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study…
- Trial name
- H06_04TP (NCT07320716)
- Testing
- AltSonflex1-2-3, Menveo, Infanrix hexa
- Where
- Kenya
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
- Trial name
- NCT07782996
- Testing
- GSK5784283, Standard of care
- Where
- 7 sites in United States
- Volunteers
- 370 people
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma
The primary purpose of this study is to evaluate the effects of Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.
- Trial name
- NCT05757102
- Testing
- FF/UMEC/VI, ELLIPTA, FF/VI
- Where
- 67 sites in United States, Argentina and 7 more
- Volunteers
- 138 people
- Sponsor
- GlaxoSmithKline
Severe Asthma
Swiss Severe Asthma Register
Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction.
- Trial name
- NCT03984253
- Where
- 10 sites in Switzerland
- Volunteers
- 600 people
- Sponsor
- Prof. Dr. Jörg Leuppi
Multidrug-resistant Tuberculosis (MDR-TB)
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge in Central Africa. Understanding the molecular epidemiology and genotypic characteristics of MDR-TB strains is crucial for effective control measures.
- Trial name
- MESTCAR (NCT07017803)
- Where
- 8 sites in Gabon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumonia, Bacterial, Pneumococcal Infections
A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
This is a Phase 2 clinical study evaluating AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of three different…
- Conditions
- Pneumonia, Bacterial, Pneumococcal Infections, Pneumonia, Pneumococcal
- Trial name
- NCT05412030
- Testing
- AFX3772, Prevnar 13, Prevnar 20
- Where
- 52 sites in United States, Puerto Rico
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Vivax
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
- Trial name
- NCT06666491
- Testing
- Tafenoquine, Primaquine, Chloroquine
- Where
- 5 sites in India
- Volunteers
- 324 people
- Sponsor
- GlaxoSmithKline
Sarcoma
A Study Evaluating the Efficacy and Safety of Risvutatug Rezetecan in Participants With Advanced Sarcomas (EMBOLD Sarcoma-202)
The main goal of this study is to test a new medicine, Risvutatug Rezetecan also called Ris-Rez. We want to see if this medicine can help people with certain types of cancer, whether its safe to use, how well people tolerate it…
- Trial name
- NCT07602777
- Testing
- Ris-Rez, G-CSF
- Where
- 13 sites in United States, Canada and 4 more
- Volunteers
- 64 people
- Sponsor
- GlaxoSmithKline
Sexually Transmitted Diseases
Prospective Registry of Exposure to Gepotidacin (PREG)
The purpose of this study is to monitor pregnancies exposed to gepotidacin and to evaluate possible teratogenic effects or birthweight-lowering effects of this medication relative to the primary outcomes of major congenital…
- Trial name
- NCT07850141
- Testing
- None (Observational study)
- Volunteers
- 614 people
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease…
- Trial name
- NCT05087056
- Testing
- MenABCWY vaccine
- Where
- 30 sites in United States, Germany
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment…
- Trial name
- NCT07371429
- Testing
- Gepotidacin, SOC
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Pneumonia, Bacterial
A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose
The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series…
- Trial name
- NCT07406334
- Testing
- Pn-MAPS30plus, PCV20
- Where
- 2 sites in South Africa
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-1)
The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.
- Trial name
- NCT07780643
- Testing
- GSK5784283, Standard of care
- Where
- United States
- Volunteers
- 514 people
- Sponsor
- GlaxoSmithKline
Vulvovaginitis, Candidal, Vulvovaginal Candidiasis
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
- Conditions
- Vulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
- Trial name
- NCT05908682
- Testing
- Non-interventional study
- Where
- India
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Salmonella Infections
A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane…
- Trial name
- NCT06213506
- Testing
- iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A
- Where
- Ghana
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria-Tetanus-acellular Pertussis Vaccines
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Healthy Japanese Adolescents Aged 11 Years to <13 Years
The purpose of the study is to assess the immune response, reactogenicity and safety of a booster dose of dTpa vaccine 1 month after vaccination in healthy Japanese participants aged 11 to <13 years.
- Trial name
- NCT07596173
- Testing
- dTpa vaccine
- Where
- 10 sites in Japan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
Tebipenem Trial in Children With Shigellosis
Background (brief): Shigellosis is the second leading cause of death due to diarrheal diseases worldwide (>200,000 deaths/year).
- Trial name
- NCT05121974
- Testing
- Tebipenem Pivoxil, Azithromycin, Ceftriaxon
- Where
- Bangladesh
- Volunteers
- 132 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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