Clinical trials: Hepatitis B Vaccine
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
HIV Coinfection
A Study Of Maraviroc In HIV Co-Infected Subjects With Hepatitis C And/Or Hepatitis B
To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.
- Trial name
- NCT01327547
- Testing
- Maraviroc
- Where
- 48 sites in United States, Czechia and 7 more
- Volunteers
- 138 people
- Sponsor
- ViiV Healthcare
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 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
Hepatitis B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis
Twinrix Pregnancy Registry
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information…
- Trial name
- NCT03619590
- Testing
- Data Collection
- Volunteers
- 245 people
- 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
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic, Chronic Hepatitis B
Study of Adefovir Dipivoxil for Korean Patients With Chronic Hepatitis B(CHB) Who Have Completed ADF 103814
This is an open label, single-arm, multi-centre extension study for Korean patients with chronic hepatitis B and compensated liver disease who have completed one-year adefovir dipivoxil treatment in ADF103814.
- Trial name
- NCT00403585
- Testing
- adefovir dipivoxil 10mg
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Polio
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00401531
- Testing
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Where
- 2 sites in Thailand
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B Infection, Malignant Solid Neoplasm
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
This phase III trial studies the effect of hepatitis B antiviral (anti-HBV) therapy in preventing liver complications in patients with chronic or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid…
- Trial name
- NCT03887702
- Testing
- Best Practice, Entecavir, Tenofovir Alafenamide
- Where
- 193 sites in United States, Guam
- Volunteers
- 4 people
- Sponsor
- SWOG Cancer Research Network
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
- Trial name
- DEFINE (NCT00410202)
- Testing
- Entecavir, Tenofovir, Adefovir
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 629 people
- Sponsor
- Bristol-Myers Squibb
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