A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process - Vaccination for Prevention of Hepatitis B Virus infection

Merck & Co., Inc.0 个研究点目标入组 900 人开始时间: 2016年9月30日最近更新: 2016年10月3日

适应症

试验速览

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•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

•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.

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