The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children
The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children
1 other identifier
observational
332
1 country
1
Brief Summary
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Longer than P75 for all trials
1 active site
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
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 28, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJuly 14, 2016
April 1, 2016
5.1 years
November 28, 2013
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
to evaluate the immune persistence of anti-HAV antibodies in serum
60 months after vaccination
Study Arms (2)
Inactivated HAV vaccine
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Attenuated alive HAV vaccine
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Interventions
Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
Eligibility Criteria
Healthy Chinese children aged 18 to 35 months old
You may qualify if:
- All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial
You may not qualify if:
- Subjects who refused to continue in the follow-up study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin center for disease prevention and control
Tianjin, 300000, China
Related Publications (1)
Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.
PMID: 28319454DERIVED
Biospecimen
Serum samples were taken from subjects.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi-Lun Zhang
Tianjin Center for Diseases Control and Prevention
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2013
First Posted
December 5, 2013
Study Start
October 1, 2008
Primary Completion
November 1, 2013
Study Completion
June 1, 2014
Last Updated
July 14, 2016
Record last verified: 2016-04