NCT00141999

Brief Summary

The purpose of this study is to determine the immune response to an additional (booster) dose of hepatitis B vaccine 5-14 years after a three dose series was given

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

May 1, 2001

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

September 1, 2005

Last Update Submit

September 26, 2012

Conditions

Hepatitis

Keywords

vaccinehepatitis

Interventions

hepatitis B vaccineBIOLOGICAL

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Received 3 doses of hepatitis B vaccine during infancy, beginning at birth

You may not qualify if:

  • Mother HBsAg-positive immunosuppressed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Native Medical Center

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

Hepatitis

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Anthony Fiore, MD

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

May 1, 2001

Primary Completion

March 1, 2005

Study Completion

March 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

US(1)