Clinical trials: HBV
Hepatitis B, Hepatitis A
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis…
- Trial name
- NCT00289744
- Testing
- TWINRIX™ ADULT, Engerix TM
- Where
- Belgium
- Volunteers
- 178 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
- Trial name
- NCT00356564
- Testing
- hepatitis B vaccine
- Where
- 42 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable…
- Trial name
- NCT00393484
- Testing
- Entecavir, Lamivudine
- Where
- 15 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection who have completed a Gilead-sponsored study of adefovir dipivoxil and require continued access to adefovir dipivoxil.
- Trial name
- NCT00158704
- Testing
- Hepsera
- Volunteers
- 400 people
- Sponsor
- Gilead Sciences
Hepatitis B, Whole Cell Pertussis
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft.
- Conditions
- Hepatitis B, Whole Cell Pertussis, Tetanus, Haemophilus Influenzae Type b
- Trial name
- NCT00332566
- Testing
- DTPw-HBV/Hib Kft vaccine GSK323527A, Tritanrix™-HepB/Hiberix™
- Where
- 2 sites in Argentina, Nicaragua
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Poliomyelitis
Post-marketing Safety Study of GSK Biological's Pediarix™ Vaccine
Pre-licensure studies of GSK Biologicals' PEDIARIX vaccine have shown it to be generally safe and unlikely to result in vaccine-associated serious adverse events.
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Tetanus
- Trial name
- NCT00146835
- Testing
- Pediarix, Licensed DTPa containing vaccine, Prevnar®: (Wyeth)
- Volunteers
- 120,794 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00291967
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- Philippines
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02257645
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Healthy Infants
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to…
- Trial name
- NCT01896739
- Testing
- Eutravac
- Where
- 7 sites in South Korea
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Diphtheria, Tetanus
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT00303316
- Testing
- DTaP-IPV//PRP~T combined vaccine
- Where
- Argentina
- Volunteers
- 458 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatitis B, Chronic
Entecavir Plus Adefovir in Lamivudine-Resistant Patients
Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant…
- Trial name
- NCT00986778
- Testing
- Lamivudine, Entecavir, Adefovir
- Sponsor
- Bristol-Myers Squibb
Vaccine Reaction, Vaccine Adverse Reaction
Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses…
- Trial name
- NCT05482295
- Testing
- In-House Recombinant Hepatitis B (Bio Farma) vaccine, Registered Hepatitis B vaccine recombinant (Engerix-B)
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Diphtheria, Pertussis
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all…
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01357720
- Testing
- Quinvaxem, Quinvaxem/Tritanrix
- Where
- Philippines
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Infections, Rotavirus
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
- Trial name
- NCT00385320
- Testing
- HRV vaccine
- Volunteers
- 2,640 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis A, Viral Hepatitis Vaccines
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
- Trial name
- NCT02112890
- Testing
- Data collection
- Where
- Mexico
- Volunteers
- 1,603 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Poliomyelitis
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Acellular Pertussis
- Trial name
- NCT01457547
- Testing
- DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA), DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
- Where
- 9 sites in Finland, Italy and 1 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™
This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received vaccination course with GSK…
- Trial name
- NCT00875485
- Testing
- Blood sampling, Additional challenge dose
- Where
- 2 sites in Belgium, Czechia
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hand, Foot and Mouth Disease
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines
The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.
- Trial name
- NCT03274102
- Testing
- Concomitant administration of EV71 vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only
- Where
- China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Chronic Hepatitis B
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
- Trial name
- NCT00316719
- Testing
- LAM group, ADV group
- Volunteers
- 105 people
- Sponsor
- GlaxoSmithKline