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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01463683
First received: October 28, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: 2XP HEPTAVAX™-II SC
Biological: 1XP HEPTAVAX™-II SC
Biological: 2XP HEPTAVAX™-II IM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
    Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

  • Percentage of Participants With Injection-site Adverse Events [ Time Frame: Up to 15 days after each vaccination ] [ Designated as safety issue: Yes ]
    Participants were evaluated for injection-site adverse events using MedDRA version 15.1

  • Percentage of Participants With Pyrexia Adverse Events [ Time Frame: Up to 15 days after each vaccination ] [ Designated as safety issue: Yes ]
    Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).


Enrollment: 722
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V232-2XP SC
2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
Biological: 2XP HEPTAVAX™-II SC
Other Names:
  • RECOMBIVAX HB
  • HBVAXPRO
Active Comparator: V232-1XP SC
1XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
Biological: 1XP HEPTAVAX™-II SC
Other Names:
  • RECOMBIVAX HB
  • HBVAXPRO
Experimental: V232-2XP IM
2XP HEPTAVAX™-II vaccine 10 mcg in 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
Biological: 2XP HEPTAVAX™-II IM

Detailed Description:

2XP HEPTAVAX™-II is manufactured using a modified process in which the composition of the amorphous aluminum hydroxyphosphate sulfate adjuvant has been modified by increasing the phosphate content by approximately 2-fold. Thus the modified process HEPTAVAX™-II is referred to as 2XP HEPTAVAX™-II.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01463683     History of Changes
Other Study ID Numbers: V232-062
Study First Received: October 28, 2011
Results First Received: October 9, 2013
Last Updated: June 23, 2014
Health Authority: Japan:Pharmaceuticals and Medical Device Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014