Phase 3
N=207
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT04490499 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™ — 99.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HBVAXPRO™ (Biological)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™ |
99.5 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen |
9.63; 685.84 | — |
Summary
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.
Eligibility Criteria
Inclusion Criteria
- Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
- Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
- The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.
Exclusion Criteria
- Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
- Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
- Has a known hypersensitivity to any component of the study vaccine.
- Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
- Has a bleeding disorder contraindicating intramuscular vaccinations.
- Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Data sourced from ClinicalTrials.gov (NCT04490499). 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.