Phase 3
N=277
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
Hepatitis B Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT00440297 ↗Enrolled (actual)
277
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 — 49; 64 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: modified process hepatitis B vaccine (Biological); Comparator: ENGERIX-B™ (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7 |
49; 64 | — |
| PRIMARY The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9 |
66; 72 | — |
| PRIMARY The Total Number of Participants With One or More Injection-Site Adverse Experiences |
43; 48 | — |
| PRIMARY The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C |
5; 6 | — |
| PRIMARY The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences |
0; 0 | — |
Summary
To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients
Eligibility Criteria
Inclusion Criteria
- Male and female subjects at least 18 years of age
- Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
- Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min
Exclusion Criteria
- Previous hepatitis B infection, vaccination with any hepatitis B vaccine
- Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
- Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
- Receipt of investigational drugs or investigational vaccines within 3 months prior
- Impairment of immunologic function
- Recent use of systemic immunomodulatory medications
- Pregnant women, nursing mothers or women planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT00440297). 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.