Phase 3
Completed N=540
Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
Source: ClinicalTrials.gov NCT00440531 ↗Enrolled (actual)
540
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) — 115; 100 Participants
Summary
The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine) |
115; 100 | — |
| SECONDARY The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine) |
121 | — |
| SECONDARY The Total Number of Participants With One or More Injection-site Adverse Experiences |
103; 115; 107 | — |
| SECONDARY The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C |
2; 3; 3 | — |
| SECONDARY The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male and female older adults greater than or equal to 50 years of age
Exclusion Criteria
- Any adult with a history of previous hepatitis B infection
- A history of vaccination with any hepatitis B vaccine
- Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
- Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
- Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
- Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
- Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
- Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
- Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
- Pregnant women, nursing mothers, and women planning to become pregnant within the study period
- Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Data sourced from ClinicalTrials.gov (NCT00440531). 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. Informational only — not medical advice.