Primary and booster vaccination in old age: Hepatitis A and Hepatitis B

Primary and booster vaccination in old age: Hepatitis A and Hepatitis B - Hepatitis vaccination in old age

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002589-38-AT

Enrollment

Registered

2013-07-01

Start date

2013-07-11

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study will analyze cellular and humoral immune reponses after primary or booster vaccination against HAV and HBV. Healthy adults will be vaccinated with a combination vaccine, which is licensed for all age groups studied in this study MedDRA version: 16.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 100000004865 MedDRA version: 16.1 Level: LLT Classification code 10063436 Term: Hepatitis A immunization System Organ Class: 100000004865 MedDRA

Interventions

Trade Name: Twinrix Adult Product Name: Twinrix Adult Pharmaceutical Form: Solution for injection Other descriptive name: HEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON ALUMINIUM PHOSPHATE Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy adults aged 20-40y OR >60y no prior vaccination against HAV and HBV OR primary vaccination against HAV and HBV more than 10 years ago based on this information participants will either receive a primary series (3 doses) or a single booster dose of vaccination signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: acute illnes chronic inflammatory disease (inflammatory bowel disease, Multiple Sclerosis) chronic infection with HBV, HCV or HIV transplant recipients persons who had chemotherapy in the past persons under immunosuppressive therapy pregnant women participation in another trial 4 weeks prior to enrollment

Design outcomes

Primary

Measure	Time frame
Main Objective: Analysis of the humoral and cellular immune reponse after primary and booster vaccination against HBV and HAV in young (20-40y) and elderly (>60y adults) and to investigate the correlation between cellular and humoral immune responses;Secondary Objective: To identify differences in the impact of age on primary and memory immune responses after vaccination Expression analysis immediately after primary and booster vaccination;Primary end point(s): quantification of vaccine-induced immune response 6 months after the last dose of vaccine;Timepoint(s) of evaluation of this end point: 6 months after the last dose of vaccine	—

Measure

Time frame

Main Objective: Analysis of the humoral and cellular immune reponse after primary and booster vaccination against HBV and HAV in young (20-40y) and elderly (>60y adults) and to investigate the correlation between cellular and humoral immune responses;Secondary Objective: To identify differences in the impact of age on primary and memory immune responses after vaccination Expression analysis immediately after primary and booster vaccination;Primary end point(s): quantification of vaccine-induced immune response 6 months after the last dose of vaccine;Timepoint(s) of evaluation of this end point: 6 months after the last dose of vaccine

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactBeatrix Grubeck-Loebenstein

University of Innsbruck, Institute for Biomedical Aging Research

beatrix.grubeck@uibk.ac.at+4351250750810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 4, 2026