Clinical trials: Biologic
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
Malaria
Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen
This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first…
- Trial name
- NCT00436007
- Testing
- GSK 257049, Tritanrix™ HepB/Hib, Rouvax™
- Where
- 3 sites in Gabon, Ghana and 1 more
- Volunteers
- 511 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Hepatitis B
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT01090453
- Testing
- GSK2202083A vaccine, Prevenar 13®, Infanrix hexa™
- Where
- 34 sites in Canada, France and 1 more
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Influenza
Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old
This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean subjects. A second group of subjects will receive FluarixTM vaccine as control.
- Trial name
- NCT01730378
- Testing
- Prepandrix™, Fluarix™
- Where
- 4 sites in South Korea
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination
The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55…
- Trial name
- NCT01934140
- Testing
- Meningococcal vaccine GSK134612
- Where
- 2 sites in Philippines
- Volunteers
- 311 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza
Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults.
- Trial name
- NCT00510874
- Testing
- Pumarix™, Pandemrix ™
- Where
- 10 sites in United States, Canada
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria, Poliomyelitis
- Trial name
- NCT00871000
- Testing
- Boostrix Polio™ 711866, Priorix Tetra TM 208136, Tetravac TM
- Where
- 8 sites in Italy
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy…
- Trial name
- NCT01094171
- Testing
- Poliorix TM, Infanrix TM
- Where
- 2 sites in Russia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Herpes Zoster
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the FLU-D-QIV vaccine in adults aged 50 years or older compared to…
- Trial name
- NCT01954251
- Testing
- Herpes Zoster vaccine GSK 1437173A, GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A
- Where
- 20 sites in United States, Canada and 1 more
- Volunteers
- 829 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
Infections, Papillomavirus
Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV vaccine…
- Trial name
- NCT00586339
- Testing
- Cervarix
- Where
- South Africa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Immunogenicity and Safety of GSK Biologicals' HPV Vaccine 580299 in Healthy Japanese Females 10-15 Years of Age
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18)…
- Trial name
- NCT00492544
- Testing
- Cervarix™ (HPV-16/18 L1 VLP AS04)
- Where
- 5 sites in Japan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Measles, Mumps
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for…
- Conditions
- Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine
- Trial name
- NCT01681992
- Testing
- Priorix, M-M-R II, Varivax
- Where
- 81 sites in United States, Czechia and 5 more
- Volunteers
- 4,538 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis, Poliomyelitis Vaccines
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
- Trial name
- NCT01021293
- Testing
- Poliorix™, Oral Poliovirus vaccine
- Where
- China
- Volunteers
- 1,101 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine in Healthy HIV Negative Adolescents
This observer blind study will assess the safety and immunogenicity of GSK Biologicals' investigational 692342 vaccine administered at 0, 1 month to healthy adolescents living in a TB-endemic region.
- Trial name
- NCT00950612
- Testing
- GSK's investigational vaccine 692342
- Where
- South Africa
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria, Malaria Vaccines
Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)
This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated…
- Trial name
- NCT01345240
- Testing
- GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049, Engerix-B™ vaccine, Infanrix/Hib™ vaccine
- Where
- 2 sites in Burkina Faso, Ghana
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study
This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in…
- Trial name
- NCT01190189
- Testing
- GSK580299 (Cervarix)
- Where
- 28 sites in United States, Canada
- Volunteers
- 137 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
Tuberculosis
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults
The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human Immunodeficiency Virus (HIV)-positive adults aged 18 to 59…
- Trial name
- NCT01262976
- Testing
- GSK's investigational vaccine 692342, Physiological saline
- Where
- India
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline