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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: HBVAXPRO™

Study type: Interventional

Funder types: Industry

Identifiers

NCT04490499

2020-000126-26 (EudraCT Number)

V419-013 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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207 participants in 1 patient group

HBVAXPRO™

Experimental group

Description:

Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

Treatment:

Biological: HBVAXPRO™