A study in healthy, young adults and healthy infants of the safety, tolerability, and immunogenicity of an investigational manufacturing process for the recombinant hepatitis B vaccine - Assessment of GSH/2X Phosphate Hepatitis B Vaccine.

Merck & Co. Inc.0 sites300 target enrollmentMarch 21, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis BICD10 classification code : Hepatitis Viral- Type B (ICD10- B16)MedDRA classification code : Infections and Infestations – Viral Hepatitis B
Sponsor: Merck & Co. Inc.
Enrollment: 300
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•a. Twenty to 35 years of age.
•b. 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.
•c. For women, a negative urine pregnancy test just prior to vaccination on Day 1\.
•d. Women of childbearing potential must demonstrate a method of effective contraception. Effective contraception includes the birth control pill or abstinence during the entire study period.
•a. Healthy infants.
•b. Two to 4 months old.
•c. Available for the study period.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•a. Medical History of previous hepatitis B infection. This includes the mothers of subjects in Stage 2\.
•b. Medical History of vaccination with any other hepatitis B vaccine. This includes the mothers of subjects in Stage 2\.
•c. Medical History of injection drug use.
•d. Recent (\<72 hours) history of febrile illness (oral temperature \=37\.8ºC/\=100\.0ºF; rectal temperature \=38\.1ºC/\=100\.5ºF ).
•e. Known or suspected hypersensitivity to any component of RECOMBIVAX HB vaccine (e.g., aluminum, yeast).
•f. Recent administration (within 3 months prior to first injection with the study vaccine) of any of the following or if any of the following are scheduled to be given during the study: hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood\-derived product (excluding autologous products).
•g. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or if scheduled to be given during the study.
•h. Known or suspected impairment of immunologic function or recent use (defined as 3 months prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
•i. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
•j. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.