Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children
2 other identifiers
interventional
248
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 1996
Longer than P75 for phase_4
2 active sites
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, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedAugust 20, 2024
August 1, 2024
4.8 years
August 29, 2005
August 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
concentration of antibody to hepatitis A virus
Sera obtained at time of first hepatitis A vaccine dose (baseline) and 1, 7, and 12 months thereafter
baseline and 1, 7, and 12 months post vax
Secondary Outcomes (2)
reported side effects and adverse events
day of vaccination and 3 days thereafter
antibodies to routine childhood vaccinations
age 13 months
Study Arms (6)
HAVRIX 6 and 12 mos; mother antibody pos
EXPERIMENTALHAVRIX administered to infants born to anti-HAV positive mothers at ages 6 and 12 months
HAVRIX age 6, 12 mos; mom antibody neg
ACTIVE COMPARATORHAVRIX administered to infants born to anti-HAV negative mothers at ages 6 and 12 months
HAVRIX ages 12, 15 mos; mom antibody +
EXPERIMENTALHAVRIX administered to infants born to anti-HAV positive mothers at ages 12 and 15 months
HAVRIX ages 12, 15 mos; mom antibody-
ACTIVE COMPARATORHAVRIX administered to infants born to anti-HAV negative mothers at ages 12 and 15 months
HAVRIX ages 15,21 mos; mom antibody +
EXPERIMENTALHAVRIX administered to infants born to anti-HAV positive mothers at ages 15 and 21 months
HAVRIX ages 15,21 mos; mom antibody -
ACTIVE COMPARATORHAVRIX administered to infants born to anti-HAV negative mothers at ages 15 and 21 months
Interventions
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centers for Disease Control and Preventionlead
- Alaska Native Medical Centercollaborator
- GlaxoSmithKlinecollaborator
Study Sites (2)
Anchorage Neighborhood Health Center
Anchorage, Alaska, 99501, United States
Alaska Native Medical Center
Anchorage, Alaska, 99508, United States
Related Publications (1)
Bell BP, Negus S, Fiore AE, Plotnik J, Dhotre KB, Williams J, Shapiro CN, McMahon BJ. Immunogenicity of an inactivated hepatitis A vaccine in infants and young children. Pediatr Infect Dis J. 2007 Feb;26(2):116-22. doi: 10.1097/01.inf.0000253253.85640.cc.
PMID: 17259872RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian McMahon
Alaska Native Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
September 1, 1996
Primary Completion
June 1, 2001
Study Completion
June 1, 2001
Last Updated
August 20, 2024
Record last verified: 2024-08