Status:

COMPLETED

A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A

Lead Sponsor:

Centers for Disease Control and Prevention

Collaborating Sponsors:

University of Michigan

Ministry of Health, Kazakhstan

Conditions:

Hepatitis A

Eligibility:

All Genders

2-40 years

Phase:

NA

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 hepatiti...

Detailed Description

Title: An Epidemiologic Study of Hepatitis A Vaccine for Postexposure Prophylaxis Clinical Phase: Investigation of an application unrelated to original approved use. Primary Objective: To compare the...

Eligibility Criteria

Inclusion

  • Exposure to an index case of hepatitis A within 14 days of onset of illness; at least 2 years and no more than 40 years of age at time of study entry; susceptible to hepatitis A; give informed consent or have informed consent given by a responsible parent/guardian -

Exclusion

  • history of hepatitis A; prior receipt of hepatitis A vaccine; receipt of immune globulin within 180 days before study entry; evidence of liver disease; receipt of any live virus vaccine within 21 days prior to study entry; moderate or severe intercurrent illness or axillary temperature of 37.5 degrees or higher at time of study entry; various other medical conditions;
  • \-

Key Trial Info

Start Date :

September 1 2003

Trial Type :

INTERVENTIONAL

End Date :

May 1 2005

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT00139139

Start Date

September 1 2003

End Date

May 1 2005

Last Update

January 13 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Sanitary EpidemiologyAuthority

Almaty, Kazakhstan