Status:
COMPLETED
Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Alaska Native Medical Center
GlaxoSmithKline
Conditions:
Hepatitis A
Eligibility:
All Genders
6-25 years
Phase:
PHASE4
Brief Summary
Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immu...
Detailed Description
Background: Infants with passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A v...
Eligibility Criteria
Inclusion
- term infant with normal growth and development, considered to be healthy at age 6 months; written informed consent by parent/guardian -
Exclusion
- received or expected to receive immune globulin or blood/blood products while enrolled; received or expected to receive immunosuppressive therapy within 30 days of vaccination or has immune deficiency; currently enrolled in another vaccine trial; progressive or unstable neurological disorder
- \-
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00139113
Start Date
September 1 1996
End Date
June 1 2001
Last Update
August 20 2024
Active Locations (2)
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1
Anchorage Neighborhood Health Center
Anchorage, Alaska, United States, 99501
2
Alaska Native Medical Center
Anchorage, Alaska, United States, 99508