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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process

NCT00440531•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria

•Any adult with a history of previous hepatitis B infection
•A history of vaccination with any hepatitis B vaccine
•Recent (\<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
•Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
•Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
•Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
•Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
•Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
•Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
•Pregnant women, nursing mothers, and women planning to become pregnant within the study period
+1 more criteria

Key Dates

Start Date

November 1, 2006

Primary Completion Date

November 1, 2007

Completion Date

November 1, 2007

Last Updated

April 13, 2017

Enrollment

540

ACTUAL participants

Conditions

Hepatitis B

Interventions

Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)

BIOLOGICAL

Comparator: Modified Process Hepatitis B Vaccine (Experimental)

BIOLOGICAL

Comparator: ENGERIX-B™ (currently licensed product)

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: April 13, 2017Data 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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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

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