A Study to Assess the Anamnestic Immune Response 4 to 6 Years After a Primary Vaccination Series With HBVAXPRO™Estudio para evaluar la respuesta inmune anamnésica 4 a 6 años después de una pauta de vacunación completa con HBVAXPRO. - Hepatitis B Vaccine (Recombinant) Booster Study

Phase 1

• Conditions: Hepatitis B; MedDRA version: 7.1Level: LLTClassification code 10019731

• Registration Number: EUCTR2006-001639-23-ES
• Lead Sponsor: Merck SHARP & DOHME DE ESPAÑA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-26
• Study Completion: 2008-06-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1478

Inclusion Criteria

?Healthy male and female children 4 to 6 years of age
?Complete medical records documenting the administration of a 3-dose series of HBVAXPRO™ or ENGERIX-B™ administered according to one of the following schedules: birth, 1, and 6 months of age; birth, 2, and 6 months of age; or 2, 4, and 6 months of age (for Cohorts A and B only).

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Birth mother known to be a carrier of hepatitis B virus (HbsAg+) or known carriers ever living in close contact with the subject
?History of previous hepatitis B infection
?History of vaccination with any hepatitis B vaccine (Cohort C only)
?History of any hepatitis B vaccination after copmletion of he 3-dose primary series (Cohorts A and B only)
?A combination of different hepatitis B vaccines used in the primary vaccination series (Cohorts A and B only)
?Recent (<72 hours) history of febrile illness (oral temperature =37.8°C [=100.0°F])
?Known or suspected hypersensitivity to any component of HBVAXPRO™ or ENGERIX-B™ (e.g., aluminum, yeast)
?Recent administration (within 3 months prior to study start) of hepatitis B immune globulin, or any other blood-derived product (excluding autologous product)
?Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?To assess the quality of the priming of HBVAXPRO™ by demonstrating acceptability of the anamnestic response after a booster dose (of either modified process hepatitis B vaccine or ENGERIX B™) in healthy children 4 to 6 years of age.<br>?To determine the ability of subjects to mount an anamnestic immune response to either HBVAXPRO™ or ENGERIX-B™<br>?To assess the safety and tolerability of a booster dose of a modified process hepatitis B vaccine in healthy children 4 to 6 years of age<br>;Secondary Objective: ?To characterize the ability of modified process hepatitis B vaccine to act as a booster dose;Primary end point(s): ?4-week postvaccination SPR (defined as an anti-HBs titer =10 mIU/mL)<br>?Safety<br>