Phase 3
N=204
Hepatitis B Challenge Dose in Adults (V232-059-10)
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT01251276 ↗Enrolled (actual)
204
Serious AEs
0.5%
Results posted
Aug 2017
Primary outcome: Primary: Percentage of Seroresponders Before and After the Challenge Vaccination — 45.5; 58.8; 85.2; 88.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Modified Process Hepatitis B Vaccine (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Seroresponders Before and After the Challenge Vaccination |
45.5; 58.8; 85.2; 88.3 | — |
| SECONDARY Percentage of Participants With One or More Adverse Experiences |
39.6; 45.8 | — |
| SECONDARY Percentage of Participants Who Discontinued the Study Due to an Adverse Experience |
0; 0 | — |
| SECONDARY Percentage of Participants With One or More Injection-site Adverse Experiences |
35.4; 29.9 | — |
| SECONDARY Percentage of Participants With One or More Systemic Adverse Experiences |
16.7; 28.0 | — |
| SECONDARY Percentage of Participants With One or More Serious Adverse Experiences |
0; 0.9 | — |
Summary
The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.
Eligibility Criteria
Inclusion Criteria
- In general good health based on a medical history.
- 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
- Known history of previous Hepatitis B infection.
- 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.
Data sourced from ClinicalTrials.gov (NCT01251276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.