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

NCT00139113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-08-20

No results posted yet for this study

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 immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.

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.

Sponsors & Collaborators

Principal Investigators

  • Brian McMahon · Alaska Native Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1996-09-30
Primary Completion
2001-06-30
Completion
2001-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00139113 on ClinicalTrials.gov