Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT01463683
• Date of registration: 28/10/2011
• Primary sponsor: Merck
• Public title: Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
• Scientific title: A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process
• Date of first enrolment: November 2011
• Target sample size: 721
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01463683
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Countries of recruitment

Japan

Key inclusion & exclusion 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).



Age minimum: 20 Years
Age maximum: 35 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Biological: 1XP HEPTAVAX-II

Biological: 2XP HEPTAVAX-II

Primary Outcome(s)

Seroprotection Rate [Time Frame: At Month 7]

Secondary ID(s)

V232-062

Source(s) of Monetary Support

Please refer to primary and secondary sponsors