Assessment of Hepatitis B Vaccine Manufactured by a Modified Process in Healthy Neonates (babies 1 to 10 days old)

Phase 1

• Conditions: Hepatitis B; MedDRA version: 19.0Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-003981-15-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-30
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age), born to mothers with documented negative test for HBsAg within 9 months prior to delivery.
Are the trial subjects under 18? yes
Number of subjects for this age range: 900
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

a. Infant born to a mother with no prenatal care.
b. Known or suspected impairment of immunologic function
c. Prior Vaccination with any hepatitis B vaccine for infant or mother (within 6
months prior to the birth of the infant).
d. Recent (<72 hours) history of febrile illness =99.5°F (=37.5°C) axillary or
=100.5°F (=38.1°C) rectal.
e. Any prior administration of hepatitis B immune globulin (HBIG), serum
immune globulin, or any other blood-derived product, or the receipt by the
mother of either immunoglobulin or HBIG within 6 months prior to birth of
the infant.
f. Receipt of investigational drugs or other investigational vaccines by mother or
infant within 3 months prior to first injection with the study vaccine or if
scheduled to be given to the infant during the study.
g. Known or suspected hypersensitivity to any component of RECOMBIVAX
HB™ (e.g., aluminum, yeast).
h. Any infant who cannot be adequately followed for study visits during the
course of the clinical study.
i. 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