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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01463683
Recruitment Status : Completed
First Posted : November 2, 2011
Results First Posted : February 17, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief 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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : November 29, 2011
Actual Primary Completion Date : November 6, 2012
Actual Study Completion Date : November 6, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection [ Time Frame: Month 7 ]
    Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.

  2. Percentage of Participants With Injection-site Adverse Events [ Time Frame: Up to 15 days after each vaccination ]
    Participants were evaluated for injection-site adverse events using MedDRA version 15.1

  3. Percentage of Participants With Pyrexia Adverse Events [ Time Frame: Up to 15 days after each vaccination ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
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No Contacts or Locations Provided
More Information
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Publications of Results:

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01463683    
Other Study ID Numbers: V232-062
First Posted: November 2, 2011    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: July 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections