Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2010-11-30
2011-04-12
Brief Summary
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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Modified Process Hepatitis B Vaccine in Base Study
Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
ENGERIX-B™ Vaccine in Base Study
Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Interventions
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Modified Process Hepatitis B Vaccine
Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.
Exclusion Criteria
* History of vaccination with any Hepatitis B vaccine within the last 2 years.
* History of febrile illness.
* Known or suspected hypersensitivity to any component of HBVaxPro.
* Receipt of medication / vaccine that may interfere with study assessments.
* Known or suspected immune impairment.
* Pregnant women and nursing mothers.
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
Other Identifiers
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rHB01C
Identifier Type: OTHER
Identifier Source: secondary_id
2006-003649-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V232-059-10
Identifier Type: -
Identifier Source: org_study_id
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