Clinical trials: Biologic
Infections, Rotavirus
Immunogenicity and Safety Study of Rotarix TM in Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after…
- Trial name
- NCT01198769
- Testing
- Rotarix TM
- Where
- Taiwan
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose…
- Trial name
- NCT00718666
- Testing
- Meningococcal vaccine GSK134612
- Where
- 14 sites in United States
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in infants previously vaccinated with human…
- Trial name
- NCT00329745
- Testing
- Rotarix™
- Where
- 4 sites in Singapore
- Volunteers
- 8,687 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.
- Trial name
- NCT01974895
- Testing
- FluLaval® Quadrivalent, Fluzone®
- Where
- 12 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old…
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT01988857
- Testing
- Boostrix™
- Where
- Vietnam
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either…
- Trial name
- NCT00370396
- Testing
- Synflorix, Prevenar, Infanrix hexa
- Where
- 35 sites in Finland, France and 1 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™.
- Trial name
- NCT00240539
- Testing
- Blood sampling
- Where
- Thailand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination…
- Trial name
- NCT00985465
- Testing
- Pneumococcal vaccine GSK1024850A
- Where
- Mali
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.
- Conditions
- Tetanus, Poliomyelitis, Neisseria Meningitidis, Haemophilus Influenzae Type b
- Trial name
- NCT00871741
- Testing
- GSK2202083A vaccine, Infanrix hexa, Menjugate
- Where
- 8 sites in Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lymphoblastic Leukemia, Acute, Lymphoblastic Leukemia, Acute, Childhood
EZN-3042 Administered With Re-induction Chemotherapy in Children With Relapsed Acute Lymphoblastic Leukemia (ALL)
An experimental drug called EZN-3042 targets survivin, a protein expressed in leukemia cells at relapse that promotes the leukemia cells to grow.
- Conditions
- Lymphoblastic Leukemia, Acute, Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Lymphoblastic, Acute, T Cell, Leukemia, Lymphoblastic, Acute
- Trial name
- NCT01186328
- Testing
- EZN-3042, Cytarabine, Doxorubicin
- Where
- 7 sites in United States, Australia
- Volunteers
- 6 people
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
Infections, Meningococcal
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2…
- Trial name
- NCT00427908
- Testing
- GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY, Meningitec™
- Where
- 11 sites in Finland
- Volunteers
- 613 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy…
- Trial name
- NCT01767376
- Testing
- Meningococcal vaccine GSK134612, Boostrix®
- Where
- 15 sites in Dominican Republic, Germany and 1 more
- Volunteers
- 692 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population…
- Trial name
- NCT01766206
- Testing
- MenACWY-CRM (Menveo)
- Where
- 54 sites in South Korea
- Volunteers
- 3,948 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Herpes Simplex
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).
- Trial name
- NCT00224484
- Testing
- GSK208141, Havrix (investigational formulation)
- Where
- 151 sites in United States, Australia and 16 more
- Volunteers
- 5,960 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose…
- Trial name
- NCT00513409
- Testing
- Synflorix, Infanrix Hexa, Havrix
- Where
- Chile
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Safety & Immunogenicity Study of 10-Valent Pneumococcal Conjugate Vaccine When Administered as a 2-Dose Schedule
Assess immuno, reacto of the 10-valent pneumococcal vaccine after 2 doses (2, 4 months of age) and after the complete 2, 4, 11 months schedule when co-administered with DTPa-HBV-IPV/Hib or DTPa-IPV/Hib (according to national…
- Trial name
- NCT00307034
- Testing
- GSK Biologicals' 10-valent pneumococcal conjugate vaccine., Infanrix hexa., Infanrix-IPV/Hib.
- Where
- 8 sites in Denmark, Norway and 2 more
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neisseria Meningitidis, Haemophilus Influenzae Type b
Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age.
- Trial name
- NCT00891176
- Testing
- MenitorixTM, Pneumococcal conjugate vaccine GSK1024850A, PrevenarTM
- Where
- 28 sites in Germany, Poland and 1 more
- Volunteers
- 582 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis A
Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young…
- Trial name
- NCT00197015
- Testing
- Havrix®, M-M-R®II, VARIVAX®
- Where
- 42 sites in United States
- Volunteers
- 1,474 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Haemophilus Influenzae Type b, Neisseria Meningitidis
Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year…
- Trial name
- NCT00326118
- Testing
- Haemophilus influenzae type b and meningococcal serogroup C (vaccine), Priorix™, Hiberix™
- Where
- 7 sites in Australia
- Volunteers
- 433 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline