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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Infection

Intervention: V232 Modified Process Hepatitis B Vaccine: Lot A (Biological); V232 Modified Process Hepatitis B Vaccine: Lot B (Biological); V232 Modified Process Hepatitis B Vaccine: Lot C (Biological); V232 Current Process Hepatitis B Vaccine (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Clinical Details

Official title: A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of Participants with Seroprotection to Hepatitis B Surface Antigen

Geometric Mean Titers to Hepatitis B Surface Antigen

Secondary outcome:

Percentage of Participants with an Adverse Experience

Percentage of Participants with an Injection-site Adverse Experience

Percentage of Participants with a Systemic Adverse Experience

Percentage of Participants with Fever (>=37.8°C, 100.0°F)

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- In general good health

- Female participants have a negative pregnancy test just prior to vaccination on Day 1

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

Locations and Contacts

Additional Information

Related publications:

Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. Epub 2009 Feb 14.

Starting date: June 2005
Last updated: October 29, 2014

Page last updated: August 20, 2015

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