Clinical trials: Biologic
Hepatitis B
Study to Compare the Efficacy of GSK Biologicals' Adjuvants in Combination With the Antigen of the Hepatitis B Vaccine
The aim of this Observer-blind study is to compare different Adjuvant Systems with the same, well-known antigen (HBsAg) already used in the GSK marketed vaccines against Hepatitis B (Engerix-BTM and FendrixTM), in order to better…
- Trial name
- NCT00805389
- Testing
- Engerix-B™, Fendrix™, GSK Biologicals' Hepatitis B vaccines (GSK223192A)
- Where
- 14 sites in Belgium, Germany
- Volunteers
- 713 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Syncytial Virus Infections
A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older Adults
The purpose of this study is to assess the safety, reactogenicity and immune responses of two doses of the investigational RSV vaccines (with different formulations), when administered intramuscularly (IM) according to a 0, 2…
- Trial name
- NCT03814590
- Testing
- RSV Vaccine (GSK3844766A) unadjuvanted low dose, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B
- Where
- 21 sites in United States, Belgium
- Volunteers
- 1,053 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary…
- Trial name
- NCT02141204
- Testing
- HRV Liquid, HRV Lyophilized
- Where
- 8 sites in India
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type b, Neisseria Meningitidis
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine…
- Trial name
- NCT00127855
- Testing
- Hib-MenCY-TT vaccine (MenHibrix), Meningitec®, ActHIB®
- Where
- 3 sites in Australia
- Volunteers
- 409 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Self-Harm, Depression
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
To measure NAC-induced changes to concentrations of glutathione (GSH) in the anterior cingulate cortex (ACC) as measured by magnetic resonance spectroscopy (MRS) in 36 adolescents and young adults with NSSI (12 in each group…
- Conditions
- Self-Harm, Depression, Suicide
- Trial name
- NCT04005053
- Testing
- N-acetyl cysteine
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of Minnesota
Infections, Papillomavirus
Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 Years Old
The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control…
- Trial name
- NCT01627561
- Testing
- Cervarix, Priorix, Infanrix
- Where
- 4 sites in Colombia, Mexico and 1 more
- Volunteers
- 148 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 Mth Schedule in Healthy Adults
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 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis…
- Trial name
- NCT00289770
- Testing
- Twinrix™
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults
This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza…
- Trial name
- NCT01626820
- Testing
- Fluviral®
- Where
- Canada
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Human Papillomavirus (HPV) Infection
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.
Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries.
- Trial name
- NCT00481767
- Testing
- Cervarix
- Where
- 2 sites in Senegal, Tanzania
- Volunteers
- 676 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240526
- Testing
- Engerix™ -B, Hepatitis B immunoglobulin (HBIg)
- Where
- Thailand
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Immunogenicity and Safety Study of Different Formulations of GlaxoSmithKline (GSK) Biologicals H7N1 Influenza Vaccine Administered to Adults 65 Years of Age and Older
The purpose of this placebo controlled study is to evaluate the safety and immunogenicity of different formulations of GSK Biologicals H7N1 influenza vaccine in subjects 65 years of age and older.
- Trial name
- NCT01949090
- Testing
- Investigational H7N1 vaccine GSK2789869A
- Where
- 8 sites in United States, Canada
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Obesity, Sarcopenia
Biological Effects of Weight Loss In Older, Obese Women
Obesity and sedentary lifestyle are associated with physical impairments and biological changes in older adults. Weight loss combined with exercise may reduce inflammation and may improve physical functioning in older adults who…
- Trial name
- WL+E (NCT01032733)
- Testing
- Lifestyle Counseling, Educational Control
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- University of Florida
Hepatitis A
Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule
The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A…
- Trial name
- NCT00291876
- Testing
- Havrix™
- Where
- Belgium
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal…
- Trial name
- NCT01035749
- Testing
- GSK Biologicals' Influenza investigational vaccine GSK2340274A, GSK Biologicals' Influenza investigational vaccine GSK2340273A
- Where
- 9 sites in Estonia, Slovakia
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Facioscapulohumeral Muscular Dystrophy
Safety, Tolerability, Pharmacokinetics (PK), and Activity of ATYR1940 in Participants With Muscular Dystrophy - Study Extension
The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies.
- Trial name
- NCT02531217
- Testing
- ATYR1940
- Where
- 3 sites in United States, Italy and 1 more
- Volunteers
- 9 people
- Sponsor
- aTyr Pharma, Inc.
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
A Study of Total Neoadjuvant Chemotherapy With FLOT VS Standard Perioperative FLOT in Patients With Gastric or GEJ Cancer
This is a randomized pilot study to evaluate and to compare the completion rates of Total Neoadjuvant chemotherapy with FLOT ( FLOT-TNT) and perioperative chemotherapy with FLOT ( FLOT-POP).
- Trial name
- TOGAR (NCT05567835)
- Testing
- Fluorouracil, Leucovorin, Oxaliplatin
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- Baylor College of Medicine
Influenza
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.
- Trial name
- NCT01218308
- Testing
- FluLaval® Quadrivalent, Havrix™
- Where
- 12 sites in Bangladesh, Dominican Republic and 6 more
- Volunteers
- 5,220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Herpes Zoster, Herpes Zoster Vaccine
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine…
- Trial name
- NCT02723773
- Testing
- Herpes Zoster Vaccine GSK1437173A
- Where
- 161 sites in United States, Australia and 16 more
- Volunteers
- 7,539 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Immunogenicity and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Season Southern Hemisphere) in Adults 18 Years of Age and Above
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine Fluarix Tetra (2015 Southern hemisphere) in adults (18 to 60 years of age) and in the elderly…
- Trial name
- NCT02369341
- Testing
- Fluarix Tetra
- Where
- 2 sites in Brazil
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alzheimer Disease
Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's Disease
The study is a 24-week, randomized, double-blind, multi-site, placebo-controlled study in participants with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD).
- Trial name
- PEGASUS (NCT03533257)
- Testing
- AMX0035
- Where
- 11 sites in United States
- Volunteers
- 95 people
- Sponsor
- Amylyx Pharmaceuticals Inc.