Clinical trials: Biologic
Psoriatic Arthritis
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs.
- Trial name
- NCT04908202
- Testing
- Deucravacitinib
- Where
- 183 sites in United States, Argentina and 19 more
- Volunteers
- 670 people
- Sponsor
- Bristol-Myers Squibb
Herpes Zoster
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in subjects' ≥ 50 years of age (YOA) who previously have had Herpes Zoster (HZ).
- Trial name
- NCT01827839
- Testing
- Herpes Zoster vaccine (GSK1437173A)
- Where
- 4 sites in Canada, Russia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Rubella, Measles
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \&…
- Conditions
- Rubella, Measles, Mumps
- Trial name
- NCT01702428
- Testing
- Priorix, M-M-R II, Varivax
- Where
- 90 sites in United States, Estonia and 4 more
- Volunteers
- 5,016 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Psoriasis
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin.
- Trial name
- OptIMMize-1 (NCT04435600)
- Testing
- Risankizumab, Ustekinumab
- Where
- 53 sites in United States, Canada and 5 more
- Volunteers
- 139 people
- Sponsor
- AbbVie
Actinic Keratosis
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by reflectance confocal microscopy.
- Trial name
- NCT01449513
- Testing
- Ingenol mebutate
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- LEO Pharma
Rheumatoid Arthritis
A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs.
- Trial name
- NCT01617005
- Testing
- Tocilizumab
- Where
- Montenegro
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Acellular Pertussis, Tetanus
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00489970
- Testing
- Taking of blood samples, Boostrix, Adacel
- Where
- 37 sites in United States
- Volunteers
- 1,954 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Evaluate Safety and Immunogenicity of GSK Bio's Influenza Vaccine GSK576389A After Repeated Vaccination in Elderly Adults
Since influenza vaccines are administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profile of GSK Biologicals' influenza vaccine GSK576389A will be re-evaluated after…
- Trial name
- NCT00538473
- Testing
- GSK Biologicals' influenza vaccine GSK576389A, Fluarix™
- Where
- Belgium
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Virus Diseases
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
The purpose of this study is to assess the safety and immunogenicity of the investigational ChAd3-EBO-Z vaccine administered to approximately 3 000 adults in Africa as a single IM dose Considering the risk of exposure to Ebola…
- Trial name
- NCT02485301
- Testing
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
- Where
- 5 sites in Cameroon, Mali and 2 more
- Volunteers
- 3,024 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe…
- Trial name
- NCT00241644
- Testing
- Rotarix™
- Where
- 13 sites in Malawi, South Africa
- Volunteers
- 2,089 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Herpes Zoster
Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older.
- Trial name
- NCT01610414
- Testing
- Herpes Zoster vaccine GSK1437173A
- Where
- 178 sites in United States, Australia and 26 more
- Volunteers
- 1,877 people
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Diphtheria
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib…
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b
- Trial name
- NCT00627458
- Testing
- Infanrix Hexa
- Where
- 6 sites in Finland
- Volunteers
- 403 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Juvenile Idiopathic Arthritis
Efficacy, Safety, Pharmacokinetics and Immunogenicity Study of Abatacept Administered Intravenously to Treat Active Polyarticular-course Juvenile Idiopathic Arthritis in Japan
The purpose of this study is to assess the efficacy of Abatacept after intravenous administration in Japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or…
- Trial name
- NCT01835470
- Testing
- Abatacept
- Where
- 13 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Influenza
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
- Trial name
- NCT00374842
- Testing
- Fluarix™, GSK1247446A
- Where
- Belgium
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Huma Papillomavirus (HPV) Vaccine 580299 in Healthy Females 15 - 25 Years of Age
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current phase 3b study is designed to assess the immunogenicity and safety of GlaxoSmithKline Biologicals' HPV…
- Trial name
- NCT00552279
- Testing
- Cervarix TM
- Where
- 16 sites in Italy, Romania and 1 more
- Volunteers
- 805 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis…
- Trial name
- NCT00289718
- Testing
- Twinrix™ adult
- Where
- Belgium
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).
- Trial name
- NCT00799825
- Testing
- GSK Biological's HPV vaccine GSK580299 (Cervarix™)
- Where
- 48 sites in United States, Canada
- Volunteers
- 346 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children
The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.
- Trial name
- NCT01003418
- Testing
- GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine, Infanrix™-IPV/Hib, Prevenar
- Where
- 4 sites in Norway
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza, Human
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
The purpose of this study is to assess the reactogenicity, safety and immunogenicity of different formulations of GlaxoSmithKline (GSK) Biologicals' investigational supra-seasonal universal influenza vaccines (SUIVs)…
- Trial name
- NCT03275389
- Testing
- D-SUIV cH8/1N1+AS03, D-SUIV cH5/1N1+AS03, D-SUIV cH11/1N1+AS03
- Where
- 6 sites in United States, Belgium
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline