A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination. (V419-013)

• Status: Not yet recruiting
• Trial end date: 2021-01-27
• Target enrollment: 200
• Participant gender: All

Summary

The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing will be performed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Vaccines

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., 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.