NCT04490499CompletedPhase 3
A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®
Merck Sharp & Dohme LLC20 sites in 1 country207 target enrollmentStarted: September 2, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 207
- Locations
- 20
- Primary Endpoint
- 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™
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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-
- •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.
Outcomes
Primary Outcomes
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™
Time Frame: Day 30
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
Secondary Outcomes
- Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen(Day 1 and Day 30)
Investigators
Study Sites (20)
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