NCT01251276

Brief Summary

The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2011

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

August 28, 2017

Completed
Last Updated

September 13, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

November 23, 2010

Results QC Date

July 26, 2017

Last Update Submit

August 24, 2022

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Percentage of Seroresponders Before and After the Challenge Vaccination

    A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.

    Predose (Day 1) and 1 month after challenge dose (Month 1)

Secondary Outcomes (5)

  • Percentage of Participants With One or More Adverse Experiences

    Up to Day 15 after challenge dose

  • Percentage of Participants Who Discontinued the Study Due to an Adverse Experience

    Up to Month 7

  • Percentage of Participants With One or More Injection-site Adverse Experiences

    Up to Day 15 after challenge dose

  • Percentage of Participants With One or More Systemic Adverse Experiences

    Up to Day 15 after challenge dose

  • Percentage of Participants With One or More Serious Adverse Experiences

    Up to Month 1 after challenge dose

Study Arms (2)

Modified Process Hepatitis B Vaccine in Base Study

EXPERIMENTAL

Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Biological: Modified Process Hepatitis B Vaccine

ENGERIX-B™ Vaccine in Base Study

EXPERIMENTAL

Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

Biological: Modified Process Hepatitis B Vaccine

Interventions

Modified Process Hepatitis B VaccineBIOLOGICAL

Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study

Also known as: HBVaxPro
ENGERIX-B™ Vaccine in Base StudyModified Process Hepatitis B Vaccine in Base Study

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In general good health based on a medical history.
  • Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

You may not qualify if:

  • Known history of previous Hepatitis B infection.
  • History of vaccination with any Hepatitis B vaccine within the last 2 years.
  • History of febrile illness.
  • Known or suspected hypersensitivity to any component of HBVaxPro.
  • Receipt of medication / vaccine that may interfere with study assessments.
  • Known or suspected immune impairment.
  • Pregnant women and nursing mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.

    PMID: 25996838RESULT

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme LLC
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

December 1, 2010

Study Start

November 30, 2010

Primary Completion

April 12, 2011

Study Completion

April 12, 2011

Last Updated

September 13, 2022

Results First Posted

August 28, 2017

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

More information