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

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®

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.

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.