NCT00139139

Brief Summary

Immune globulin is effective about 85% of the time in preventing hepatitis A in people who have been exposed, if it is given within 14 days of exposure. Several lines of evidence suggest that hepatitis A vaccine might also be effective in this setting, and vaccine has the advantage of providing long term protection. In this study, we compare how well immune globulin and hepatitis A vaccine work in preventing clinical hepatitis A in household contacts of persons with the disease. The study's hypothesis is that the the proportion of exposed household contacts who receive hepatitis A vaccine within 14 days of exposure and develop hepatitis A disease will be similar to the proportion of exposure household contacts who receive immune globulin within 14 days of exposure and develop hepatitis A disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

First QC Date

August 29, 2005

Last Update Submit

December 27, 2021

Conditions

Hepatitis A

Keywords

hepatitis Ahepatitis A vaccineimmune globulin

Outcome Measures

Primary Outcomes (1)

  • clincal hepatitis A disease

Secondary Outcomes (2)

  • 1) subclinical hepatitis A

  • 2) asymptomatic hepatitis A virus infection, with hepatitis A virus viremia

Interventions

Hepatitis A vaccineBIOLOGICAL

Eligibility Criteria

Age2 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanitary EpidemiologyAuthority

Almaty, Kazakhstan

Location

Related Publications (1)

  • Victor JC, Monto AS, Surdina TY, Suleimenova SZ, Vaughan G, Nainan OV, Favorov MO, Margolis HS, Bell BP. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007 Oct 25;357(17):1685-94. doi: 10.1056/NEJMoa070546. Epub 2007 Oct 18.

    PMID: 17947390DERIVED

MeSH Terms

Conditions

Hepatitis AHepatitis

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Beth P Bell, MD, MPH

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

September 1, 2003

Study Completion

May 1, 2005

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

KA(1)