Hepatitis B Clinical Trial
Official title:
Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722)
and booster vaccination in Study A3L27 (NCT01444781).
Study Objective:
- To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a
3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7)
+Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of
age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix
hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.
Observational Objectives:
- To describe the long-term antibody persistence by group and by stratification on the
age at inclusion of the A3L27 booster study.
- To describe the effect of one additional oral dose of stand alone poliovirus isotypes
1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes
(4 vs 5 doses of poliovirus administered).
No investigational vaccine will be administered in the study. Subjects who were previously
randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be
invited to take part in this study.
Any serious adverse events (SAEs) related to the vaccines administered during the preceding
trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the
trial.
No vaccine will be administered as part of this study.
;
Allocation: Non-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 | |
| 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 |
NCT02540538 -
Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders
|
Phase 1 | |
| 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 |
NCT01368497 -
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
|
Phase 3 | |
| Completed |
NCT01732354 -
Study for Consolidation Period of Chronic Hepatitis B
|
||
| Recruiting |
NCT01462981 -
Cohort of Hepatitis B Research of Amsterdam
|
N/A |