Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: 2XP HEPTAVAX™-II SC; 1XP HEPTAVAX™-II SC; 2XP HEPTAVAX™-II IM
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 722.0
Sex: All
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II
      compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
    

Eligibility criteria:

        Inclusion Criteria:

        To receive the first study vaccination, Participants should meet all inclusion criteria.

          -  Participants provide written informed consent for the trial. The Participant may also
             provide consent for Future Biomedical Research. However, the Participant may
             participate in the main trial without participating in Future Biomedical Research.

          -  Participant is Japanese male or female, between 20 to 35 years of age on the day of
             the first study vaccination.

          -  Participant is determined to be in general good health based on the medical history
             taken on Day 1 prior to receiving the first injection of the vaccine. Any underlying
             chronic illness must be documented to be in stable condition.

          -  For females, a negative urine pregnancy test just prior to vaccination on Day 1.

        Exclusion Criteria:

        To receive the first study vaccination, Participants should not have any exclusion
        criteria. For items with an asterisk (*), if the Participant meets these exclusion
        criteria, the visit may be rescheduled for a time when these criteria are not met.

          -  Participant has a history of previous hepatitis B infection.

          -  Participant has a history of vaccination with any hepatitis B vaccine.

          -  *Participant has a recent (≤72 hours) history of febrile illness (oral temperature ≥
             37.8°C).

          -  Participant has a known or suspected hypersensitivity to any component of HEPTAVAX™-II
             vaccine and latex (e.g., aluminum, yeast).

          -  Participant has a 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, or is expected to require such blood-derived products
             during the study.

          -  *Participant has received licensed inactivated vaccines within 14 days prior or
             licensed live vaccines within 28 days prior to first injection with the study vaccine.

          -  Participant has received investigational drugs or other investigational vaccines
             within 3 months prior to first injection with the study vaccine.

          -  Use of immunosuppressive therapy. Participants on corticosteroids should be excluded
             if they are receiving or are expected to receive, in the period from 4 weeks prior to
             enrollment until 6 weeks post vaccination, systemic doses greater than required for
             physiological replacement, i.e., >5 mg of prednisone (or equivalent) per day for >2
             weeks (except for use of topical or inhalation steroid therapy).

          -  Pregnant women, nursing mothers, and women planning to become pregnant within the
             study period. Women of childbearing age should employ an acceptable method of
             contraception during the study (e.g., condom, diaphragm, oral contraceptive,
             Intrauterine Device (IUD), or hormonal implants are considered acceptable).

          -  Participant has any condition, which, in the opinion of the investigator, might
             interfere with the evaluation of the study objectives.

          -  Participant has a coagulation disorder contraindicating intramuscular injection.

          -  Participant has immunocompromised condition (such as Human Immunodeficiency Virus
             (HIV) positive, leukemia, lymphoma, other cancers or disorders).