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A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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®

NCT04490499•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

8 - 10 years

Sex

ALL

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 V419-008.
•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.

Locations (10)

Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)

Kokkola, Keski-Pohjanmaa, Finland

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)

Oulu, North Ostrobothnia, Finland

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)

Tampere, Pirkanmaa, Finland

Seinajoki Vaccine Research Center ( Site 0010)

Seinajoki, Pohjanmaa, Finland

Porin rokotetutkimusklinikka ( Site 0008)

Pori, Satakunta, Finland

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)

Turku, Southwest Finland, Finland

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)

Espoo, Uusimaa, Finland

Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)

Helsinki, Uusimaa, Finland

Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)

Helsinki, Uusimaa, Finland

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)

Jarvenpaa, Uusimaa, Finland

Key Dates

Start Date

September 2, 2020

Primary Completion Date

December 29, 2020

Completion Date

December 29, 2020

Last Updated

July 27, 2022

Enrollment

207

ACTUAL participants

Conditions

Hepatitis B

Interventions

HBVAXPRO™

BIOLOGICAL

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

NCT07024641

Hepatitis B Virus Infection

View study

RECRUITINGPHASE1

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

hUC Mesenchymal Stem Cells (19#iSCLife®-LC) in the Treatment of Decompensated Hepatitis b Cirrhosishepatitis b Cirrhosis

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series