Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
|ClinicalTrials.gov Identifier: NCT01463683|
Recruitment Status : Completed
First Posted : November 2, 2011
Results First Posted : February 17, 2014
Last Update Posted : April 13, 2017
Merck Sharp & Dohme Corp.
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.
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||722 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study in Healthy Japanese Young Adults to Assess the Safety, Tolerability, and Immunogenicity of HEPTAVAX-II Manufactured Using a Modified Process|
|Study Start Date :||November 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
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|
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).
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