Study in Healthy Young Adults to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade - Assessment of Hepatitis B Vaccine Manufactured by a Process Upgrade

Merck & Co., Inc0 个研究点目标入组 860 人开始时间: 2005年4月21日最近更新: 2012年3月19日

试验速览

暂无简介。

•1. Twenty to 35 years of age.
•2. In general good health based on a medical history taken on Day 1 prior to receiving the first injection of vaccine. Any underlying chronic illness must be documented to be in stable condition.
•3. For women, a negative urine pregnancy test just prior to vaccination on Day 1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•1. History of previous hepatitis B infection.
•2. History of vaccination with any hepatitis B vaccine.
•3. Recent (less than 72 hours) history of febrile illness (oral temperature =37.7ºC/100.0ºF).
•4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast).
•5. Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product.
•6. Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine.
•7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
•8. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
•9. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
•10. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

发起方