Clinical trials: Biologic
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
Haemophilus Influenzae Type b, Neisseria Meningitidis
Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™…
- Trial name
- NCT00258700
- Testing
- Haemophilus influenzae type b- and meningococcal (vaccine)
- Where
- 10 sites in Poland, United Kingdom
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or…
- Trial name
- NCT02153333
- Testing
- Serum sample
- Volunteers
- 1 people
- 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
Infections, Streptococcal
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.
- Trial name
- NCT00334334
- Testing
- Pneumococcal (vaccine)
- Where
- 66 sites in Germany, Poland and 1 more
- Volunteers
- 1,572 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Degenerative Disc Disease, Spinal Stenosis
Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
- Trial name
- SPO (NCT00726284)
- Where
- 5 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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
Pancreas Cancer
Clinical Utility Study for Exo-PDAC
This is a national-level research study of oncologists, interventional gastroenterologists, and primary care providers. The purpose of this study is to assess the clinical evaluation and management (drug, procedures, counseling…
- Trial name
- NCT05702385
- Testing
- Educational Materials for a new diagnostic test
- Where
- United States
- Sponsor
- Qure Healthcare, LLC
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
Hepatitis B
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults
This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine
- Trial name
- NCT00697853
- Testing
- Engerix™-B, HBV-MPL vaccine 208129
- Where
- Belgium
- Volunteers
- 200 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
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10…
- Trial name
- NCT00383591
- Testing
- Hepatitis B adjuvanted vaccine, Engerix-B
- Where
- 5 sites in Czechia, Malaysia and 1 more
- Volunteers
- 120 people
- 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
Infections, Meningococcal
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years.
- Trial name
- NCT00196976
- Testing
- Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
- Where
- 17 sites in Austria, Greece
- Volunteers
- 461 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Hepatitis B
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
The purpose of this study is to compare the reactogenicity \& safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.
- Conditions
- Diphtheria, Hepatitis B, Whole Cell Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00317135
- Testing
- Tritanrix-HepB/Meningitec conjugate vaccine, Tritanrix/Hiberix vaccine
- Where
- Philippines
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Heart Diseases
Evaluate Safety and Effectiveness of XenoSure Biological Patch in the Application of Cardiac Repair
The purpose of this clinical trial is to collect safety and effectiveness data to support cardiac repair indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulations for this kind of device.
- Trial name
- NCT03176225
- Testing
- Open heart surgery to address the heart disease, Close the defects with XenoSure Patch, Close the defects with Chest Polyester Patch
- Where
- China
- Volunteers
- 142 people
- Sponsor
- LeMaitre Vascular
Influenza
Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children
The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.
- Trial name
- NCT01014091
- Testing
- GSK pandemic vaccine GSK2340272A
- Where
- 3 sites in Czechia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary…
- Trial name
- NCT01235949
- Testing
- GSK1024850A (SynflorixTM), Infanrix hexa, Infanrix-IPV/Hib
- Where
- 23 sites in Romania
- Volunteers
- 850 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Hepatitis B
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants
The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted…
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Whole Cell Pertussis
- Trial name
- NCT00197275
- Testing
- Hib-MenAC mixed with Tritanrix™-HepB
- Where
- 3 sites in Thailand
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline