Clinical trials: Biologic
Hepatitis B
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00240500
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.
- Trial name
- NCT02242643
- Testing
- FluLaval™ Quadrivalent, Fluzone® Quadrivalent
- Where
- 66 sites in United States, Mexico
- Volunteers
- 2,432 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Measles, Varicella
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.
- Conditions
- Measles, Varicella, Mumps, Rubella
- Trial name
- NCT00751348
- Testing
- PriorixTM, VarilrixTM, Priorix-Tetra®
- Where
- 13 sites in South Korea
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.
- Trial name
- NCT00971321
- Testing
- Pandemic influenza vaccine GSK2340272A
- Where
- 5 sites in Spain
- Volunteers
- 157 people, healthy volunteers welcome
- 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
Infections, Meningococcal
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to…
- Trial name
- NCT00508261
- Testing
- Meningococcal vaccine GSK134612, Infanrix™ hexa, Meningitec™
- Where
- 89 sites in Austria, Germany and 1 more
- Volunteers
- 793 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response…
- Trial name
- NCT02052661
- Testing
- Engerix™-B Kinder
- Where
- 11 sites in Germany
- Volunteers
- 301 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
Poliomyelitis
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
- Trial name
- NCT00937404
- Testing
- Poliorix
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal
Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 Years
The purpose of the current study is to evaluate whether there is immune interference when MenABCWY [consisting of MenACWY lyophilized component and rMenB+OMV NZ (Bexsero) liquid component] is administered to healthy adolescents…
- Trial name
- NCT03587207
- Testing
- MenABCWY vaccine, rMenB+OMV NZ (Bexsero) vaccine, MenACWY (Menveo) vaccine
- Where
- Czechia
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Varicella
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety.
- Trial name
- NCT00568334
- Testing
- Varilrix (inactivated varicella vaccine)
- Where
- 13 sites in Czechia, Hungary
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Papillomavirus
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb).
- Trial name
- NCT00196937
- Testing
- Cervarix
- Where
- 6 sites in Germany, Poland
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Immunogenicity of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine
In this study, subjects who received primary neonatal vaccination with hepatitis B vaccine at 0, 1, 2, 12 months, 20 years ago in the 103860/272 primary study will be evaluated for immunological memory to hepatitis B vaccine via…
- Trial name
- NCT00657657
- Testing
- Engerix™-B
- Where
- Thailand
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals'…
- Trial name
- NCT01777308
- Testing
- Meningococcal conjugate vaccine GSK134612
- Where
- 8 sites in Australia
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered…
- Trial name
- NCT00758264
- Testing
- Meningococcal vaccine GSK134612, Pneumococcal vaccine GSK1024850A
- Where
- 5 sites in Mexico, Taiwan
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib…
- Trial name
- NCT00609492
- Testing
- GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A), Infanrix™-IPV/Hib
- Where
- 7 sites in Greece, Spain
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Combined Study - Phase 3b MenB Long Term Persistence in Adolescents
The purpose/aim of this study is to assess 1) the long-term persistence (4 to 7.5 years after the last dose) of bactericidal activity following primary vaccination with rMenB+OMV NZ in adolescents [who previously participated in…
- Trial name
- NCT02446743
- Testing
- rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)
- Where
- 12 sites in Australia, Canada and 1 more
- Volunteers
- 531 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a…
- Trial name
- NCT00345358
- Testing
- Synflorix, Infanrix IPV/Hib
- Where
- 10 sites in Finland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline