Clinical trials: Hepatitis B
Diphtheria, Tetanus
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02858440
- Testing
- Infanrix-IPV/Hib
- Where
- 5 sites in Russia
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Apnea, Apnea Neonatal
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North…
- Conditions
- Apnea, Apnea Neonatal, Prematurity
- Trial name
- NCT03530124
- Testing
- PCV13, DTaP, HBV
- Where
- 4 sites in United States
- Volunteers
- 223 people
- Sponsor
- Duke University
Chronic Hepatitis B
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
- Trial name
- NCT01817725
- Testing
- HBV vaccine (Engerix B)
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- Chang Gung Memorial Hospital
Chronic Hepatitis B
Study Comparing Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC)/TDF, and Entecavir (ETV) in the Treatment of Chronic HBV in Subjects With Decompensated Liver Disease.
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver…
- Trial name
- NCT00298363
- Testing
- Tenofovir disoproxil fumarate (tenofovir DF; TDF), Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), Entecavir (ETV)
- Where
- 38 sites in United States, Canada and 9 more
- Volunteers
- 112 people
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01948193
- Testing
- Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
- Where
- 2 sites in India
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis A
Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a diphtheria, tetanus and pertussis combination (DTaP) vaccine and a Haemophilus…
- Trial name
- NCT00197236
- Testing
- Havrix™, Infanrix™, ActHIB™
- Where
- 22 sites in United States
- Volunteers
- 468 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
The Effect of an Electronic Medical Record (EMR) Alert on Hepatitis B Screening
Asian and Pacific Islander Americans at risk, but never tested for chronic hepatitis B have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for…
- Trial name
- NCT04240678
- Testing
- Electronic HBV Alert
- Volunteers
- 8,299 people
- Sponsor
- University of California, Davis
Acellular Pertussis, Hepatitis B
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence…
- Conditions
- Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT01453998
- Testing
- Infanrix hexa, Prevenar 13, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 657 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age
- Trial name
- NCT01005407
- Testing
- Engerix-B
- Where
- 32 sites in United States, Canada
- Volunteers
- 2,452 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Hepatitis, Hepatitis B, Chronic
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Trial name
- NCT00076336
- Testing
- Telbivudine, Lamivudine
- Where
- 28 sites in United States, Australia and 19 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B Virus, Pediatric
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
- Trial name
- NCT01079806
- Testing
- Entecavir
- Where
- 44 sites in United States, Argentina and 12 more
- Volunteers
- 180 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B Virus Infection
A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B…
- Trial name
- NCT03762681
- Testing
- RO7239958
- Where
- 14 sites in Bulgaria, Hong Kong and 5 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose…
- Trial name
- NCT00158756
- Testing
- Tritanrix™-HepB, Rotarix™, Zilbrix™
- Where
- 9 sites in Russia
- Volunteers
- 308 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
- Trial name
- NCT01777295
- Testing
- Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B
- Where
- Belgium
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Chronic
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection
This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.
- Trial name
- NCT05612581
- Testing
- VIR-3434, VIR-2218, TDF
- Where
- 15 sites in France, Hong Kong and 4 more
- Volunteers
- 33 people
- Sponsor
- Vir Biotechnology, Inc.
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