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

Merck & Co. Inc.0 sites1,700 target enrollmentAugust 4, 2006

ConditionsHepatitis B MedDRA version: 7.1Level: LLTClassification code 10019731

DrugsENGERIX-B

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: Merck & Co. Inc.
Enrollment: 1700
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 4, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck & Co. Inc.

Eligibility Criteria

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.