Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: November 2, 2011
Last Update Posted: April 13, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Hepatitis B||Biological: 2XP HEPTAVAX™-II SC Biological: 1XP HEPTAVAX™-II SC Biological: 2XP HEPTAVAX™-II IM||Phase 3|
|Study Design:||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|
Resource links provided by NLM:
U.S. FDA Resources
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 ]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 ]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 ]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).
|Study Start Date:||November 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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
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
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|
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.
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