Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age - Hepatitis B Vaccine (Recombinant) Infant Dose Study

Phase 1

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

• Registration Number: EUCTR2006-001638-42-NO
• Lead Sponsor: MSD (Norge) AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-24
• Study Completion: 2007-10-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1718

Inclusion Criteria

Healthy male and female infants ~2 months of age (40 to 80 days).
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

1. Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or another known carrier of hepatitis B virus ever living in close contact with the subject.
2. Birth mother, during the course of this pregnancy, did not receive any prenatal care.
3. Previous history of hepatitis B infection.
4. Known or suspected impairment of immunologic function or prior use (defined as 14 days prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
5. Prior vaccination with any hepatitis B vaccine for infant or mother (within 6 months prior to birth of child).
6. Recent (<72 hours) history of febrile illness ³99.5°F (³37.5°C) axillary or ³100.5°F (³38.1°C), rectal temperature.
7. Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product in the subject, or receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the child.
8. Any prior receipt of investigational drugs or other investigational vaccines by the infant since birth or by the mother if breastfeeding within 14 days prior to first injection with the study vaccine or if scheduled to be given to the infant during the study.
9. Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast).
10. Any infant who cannot be adequately followed for study visits during the course of the clinical study.
11. 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