Hepatitis B Clinical Trial
Official title:
Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) Compared to Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) and Hepatitis B Vaccine Given Concurrently In Adolescents 11-14 Years of Age
Primary objective:
- To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed
combined with component pertussis and inactivated poliomyelitis vaccine grown on vero
cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with
component pertussis and inactivated poliomyelitis vaccine grown on vero cells
(TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years
of age.
Secondary objective:
- To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at
11-14 years of age results in detectable immunologic interactions between components of
the two vaccines.
Participants will be randomized into one of 2 groups to receive either a dose of the
TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group
1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B
vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).
All participants will be followed up for immunogenicity and safety
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01182311 -
Duration of Long-term Immunity After Hepatitis B Virus Immunization
|
||
| Completed |
NCT04971928 -
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT03285620 -
A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants
|
Phase 1 | |
| Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
| Recruiting |
NCT05404919 -
Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates
|
Phase 2 | |
| Completed |
NCT02153320 -
Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT00352963 -
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
|
Phase 3 | |
| Completed |
NCT03567382 -
Arresting Vertical Transmission of Hepatitis B Virus
|
Phase 4 | |
| Not yet recruiting |
NCT04056728 -
A Phase IV Study to Assess the Safety of EupentaTM Inj
|
Phase 4 | |
| Not yet recruiting |
NCT03604016 -
Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
|
Phase 4 | |
| Completed |
NCT00753649 -
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
|
Phase 4 | |
| Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
| Completed |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
| Terminated |
NCT02604199 -
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
| Completed |
NCT02421666 -
A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV
|
N/A | |
| Completed |
NCT02169674 -
Hepatitis B Booster Study in Adolescence
|
Phase 4 | |
| Completed |
NCT01917357 -
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
|
Phase 3 | |
| Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
| Completed |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
| Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |