NCT00393523

Brief Summary

To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,478

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2006

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

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 12, 2009

Completed
Last Updated

April 12, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

October 25, 2006

Results QC Date

May 27, 2009

Last Update Submit

March 15, 2017

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy

    Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.

    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Secondary Outcomes (1)

  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy

    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Other Outcomes (2)

  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy

    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

  • Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy

    4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B

Study Arms (5)

5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)

ACTIVE COMPARATOR

Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose).

Biological: Comparator: Modified Process Hepatitis B Vaccine

10 µg ENGERIX-B™ Booster (Group 2)

ACTIVE COMPARATOR

Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose)

Biological: Comparator: Comparator: ENGERIX-B

5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)

ACTIVE COMPARATOR

Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose).

Biological: Comparator: Modified Process Hepatitis B Vaccine

10 µg ENGERIX-B™ Booster (Group 4)

ACTIVE COMPARATOR

Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose).

Biological: Comparator: Comparator: ENGERIX-B

5 µg Modified Process Hepatitis B Vaccine (Group 5)

EXPERIMENTAL

Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine.

Biological: Comparator: Modified Process Hepatitis B Vaccine

Interventions

Comparator: Modified Process Hepatitis B VaccineBIOLOGICAL

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

5 µg Modified Process Hepatitis B Vaccine (Group 5)5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)
Comparator: Comparator: ENGERIX-BBIOLOGICAL

Single dose 10 µg/0.5ml ENGERIX-B

10 µg ENGERIX-B™ Booster (Group 2)10 µg ENGERIX-B™ Booster (Group 4)

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy Children 4 to 8 years of age
  • Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
  • Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

You may not qualify if:

  • Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
  • History of previous hepatitis B vaccine
  • History of vaccination with any hepatitis B vaccine (Cohort C only)
  • Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
  • Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
  • Impairment of immunologic function or recent use of immunomodulatory medications
  • A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.

    PMID: 20724955RESULT

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    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
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 27, 2006

Study Start

September 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 12, 2017

Results First Posted

October 12, 2009

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php