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
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
Infections, Meningococcal
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with…
- Trial name
- NCT03621670
- Testing
- Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix
- Where
- 57 sites in United States, Puerto Rico
- Volunteers
- 1,196 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to…
- Trial name
- NCT04179032
- Testing
- Belimumab
- Where
- 11 sites in United States, Argentina and 5 more
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Hypereosinophilic Syndrome
Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE)
The purpose of this study is to investigate the efficacy and safety of mepolizumab in children and adolescents with hypereosinophilic syndrome (HES) who are receiving standard of care (SoC) therapy.
- Trial name
- SPHERE (NCT04965636)
- Testing
- Mepolizumab
- Where
- 14 sites in United States, Argentina and 4 more
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused…
- Trial name
- NCT05082285
- Testing
- MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, MenABCWY-1Gen vaccine
- Where
- 33 sites in Dominican Republic, Finland and 6 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
BENLYSTA® Special Drug Use Investigation
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta")…
- Trial name
- NCT03370263
- Testing
- Benlysta
- Where
- Japan
- Volunteers
- 1,514 people
- Sponsor
- GlaxoSmithKline
Asthma
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically…
- Trial name
- NIMBLE (NCT04718389)
- Testing
- GSK3511294 (Depemokimab), Mepolizumab, Benralizumab
- Where
- 397 sites in United States, Australia and 19 more
- Volunteers
- 1,717 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
- Trial name
- NCT04908865
- Testing
- Belimumab, Standard therapy
- Where
- 9 sites in China
- Volunteers
- 67 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
- Trial name
- PLUTO (NCT01649765)
- Testing
- Belimumab 10 mg/kg
- Where
- 32 sites in United States, Argentina and 8 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
- Trial name
- NCT05705440
- Testing
- RSVPreF3 vaccine, Control
- Where
- 138 sites in United States, Argentina and 21 more
- Volunteers
- 3,855 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
NUCALA® Special Drug Use Investigation (EGPA, Long-term)
This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in…
- Trial name
- NCT03557060
- Testing
- Nucala
- Where
- Japan
- Volunteers
- 4,115 people
- Sponsor
- GlaxoSmithKline
Urinary Tract Infections
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
- Trial name
- SIS (NCT06597344)
- Testing
- Gepotidacin
- Where
- 22 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Participants With Solid Tumors (SCOOP)
This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the paediatric population.
- Trial name
- NCT04544995
- Testing
- Niraparib (Tablet for oral suspension), Dostarlimab, Niraparib (Tablet)
- Where
- 2 sites in United Kingdom
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Asthma
An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103)
The purpose of this open-label 12-month extension study is to continue to characterize the long-term safety, efficacy and immunogenic profile of GSK3511294 (Depemokimab) in participants with severe asthma with an eosinophilic…
- Trial name
- AGILE (NCT05243680)
- Testing
- GSK3511294 (Depemokimab)
- Where
- 137 sites in United States, Australia and 12 more
- Volunteers
- 641 people
- Sponsor
- GlaxoSmithKline
Systemic Lupus Erythematosus
A Study of Belimumab in Chinese Pediatric Participants With Systemic Lupus Erythematosus
This study will evaluate the pharmacokinetic characteristics and safety of belimumab subcutaneous (SC) in Chinese pediatric participants with SLE who have completed 48 weeks belimumab Intravenous (IV) treatment in 213560 study…
- Trial name
- NCT05917288
- Testing
- Belimumab, Standard of care
- Where
- 6 sites in China
- Volunteers
- 16 people
- Sponsor
- GlaxoSmithKline
Anaemia
Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated…
- Trial name
- ASCEND-P (NCT05682326)
- Testing
- Daprodustat
- Where
- 4 sites in Japan, South Korea
- Volunteers
- 4 people
- Sponsor
- GlaxoSmithKline
Gastroenteritis
A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants
The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese…
- Trial name
- NCT06331156
- Testing
- HRV PCV-free, IPV
- Where
- 5 sites in China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline