A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process - Older Adult Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003649-18-SE

Enrollment

540

Registered

2006-11-14

Start date

2007-01-12

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Hepatitis B MedDRA version: 8.1 Level: LLT Classification code 10019731 Term: Hepatitis B

Interventions

Product Name: Hepatitis B Vaccine (Recombinant) Modified Process Pharmaceutical Form: Suspension for injection Other descriptive name: Hepatitis B Vaccine (Recombinant) Modified Process Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Generally healthy male and female adults =50 years of age. • Prior to vaccination a full medical history. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Prior history of hepatitis B infection or vaccination with any hepatitis B vaccine • Recent febrile illness • Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminium, yeast). • Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product. • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. • Known or suspected impairment of immunologic function or recent (within past 14 days) use of immunomodulatory medications (e.g., systemic corticosteroids • Receipt of investigational drugs or other investigational vaccines within 14 days prior to first injection with the study vaccine.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To describe the seroprotection rate (SPR) one month after the third dose of vaccine for a modified process hepatitis B vaccine in healthy adults (=50 years of age).;Secondary Objective: 1. Describe the responses in anti-HBs as measured by SPR one month after the third dose for ENGERIX-B™ 2. Describe the safety and tolerability of the modified process vaccine in healthy adults (=50 years of age). ;Primary end point(s): One Month postvaccination SPR (defined as an anti-HB titer =10mIU/mL).	—

Measure

Time frame

Main Objective: 1. To describe the seroprotection rate (SPR) one month after the third dose of vaccine for a modified process hepatitis B vaccine in healthy adults (=50 years of age).;Secondary Objective: 1. Describe the responses in anti-HBs as measured by SPR one month after the third dose for ENGERIX-B™ 2. Describe the safety and tolerability of the modified process vaccine in healthy adults (=50 years of age). ;Primary end point(s): One Month postvaccination SPR (defined as an anti-HB titer =10mIU/mL).

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Countries

Sweden, United Kingdom

Outcome results

None listed

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