A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Phase 3

Completed

• Conditions: Hepatitis B Infection
• Interventions: Biological: V232 Current Process Hepatitis B Vaccine

• Registration Number: NCT00489099
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

• In general good health
• Female participants have a negative pregnancy test just prior to vaccination on Day 1

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Exclusion Criteria

• History of Hepatitis B Infection or vaccination
• Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
• Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
• Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
• Participation on prior study using an investigational drug or vaccine in prior 3 months
• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
• Pregnant or nursing women or women planning to become pregnant within the study period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V232 Current Process Hepatitis B Vaccine	V232 Current Process Hepatitis B Vaccine	Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Seroprotection to Hepatitis B Surface Antigen	1 month after the third vaccination (Month 7)
Geometric Mean Titers to Hepatitis B Surface Antigen	1 month after the third vaccination (Month 7)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Fever (>=37.8°C, 100.0°F)	Up to 5 days after any vaccination
Percentage of Participants with an Injection-site Adverse Experience	Up to 15 days after any vaccination
Percentage of Participants with an Adverse Experience	Up to 15 days after any vaccination
Percentage of Participants with a Systemic Adverse Experience	Up to 15 days after any vaccination