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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00489099
Other study ID # V232-054
Secondary ID 2007_565
Status Completed
Phase Phase 3
First received June 20, 2007
Last updated March 15, 2017
Start date June 2005
Est. completion date May 2006

Study information

Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 860
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
V232 Modified Process Hepatitis B Vaccine: Lot A

V232 Modified Process Hepatitis B Vaccine: Lot B

V232 Modified Process Hepatitis B Vaccine: Lot C

V232 Current Process Hepatitis B Vaccine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Seroprotection to Hepatitis B Surface Antigen 1 month after the third vaccination (Month 7)
Primary Geometric Mean Titers to Hepatitis B Surface Antigen 1 month after the third vaccination (Month 7)
Secondary Percentage of Participants with an Adverse Experience Up to 15 days after any vaccination
Secondary Percentage of Participants with an Injection-site Adverse Experience Up to 15 days after any vaccination
Secondary Percentage of Participants with a Systemic Adverse Experience Up to 15 days after any vaccination
Secondary Percentage of Participants with Fever (>=37.8°C, 100.0°F) Up to 5 days after any vaccination
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