Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children

PHASE4CompletedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

September 30, 1996

Primary Completion Date

June 30, 2001

Study Completion Date

June 30, 2001

Conditions
Hepatitis A
Interventions
BIOLOGICAL

hepatitis A vaccine

2 doses of inactivated hepatitis A vaccine manufactured by GSK in licensed pediatric formulation of 720 EL. U. per dose given on 3 different schedules: aged 6 and 12 months, 12 and 18 months, and 15 and 21 months. Within each group, subjects were randomized to achieve a relatively equal number of children born to anti-HAV positive and anti-HAV negative mothers.

Trial Locations (2)

99501

Anchorage Neighborhood Health Center, Anchorage

99508

Alaska Native Medical Center, Anchorage

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alaska Native Medical Center

OTHER

collaborator

GlaxoSmithKline

INDUSTRY

lead

Centers for Disease Control and Prevention

FED