A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
1 other identifier
observational
10,077
1 country
3
Brief Summary
The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
3 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
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedMay 26, 2022
May 1, 2015
1 year
November 27, 2013
May 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71
Within the second year after the second vaccination
Secondary Outcomes (2)
The GMT of anti-EV71 antibodies in serum two years after second vaccination
26 months after second vaccination
Frequency of serious adverse events (SAEs) with the second year after the second vaccination
within the second year after the second vaccination
Study Arms (2)
EV71 Vaccine
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Placebo
placebo in 5000 infants aged 6-35 months old on day0,28
Interventions
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Eligibility Criteria
Healthy Chinese infants aged 6 to 35 months old
You may qualify if:
- All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.
You may not qualify if:
- subjects who refuse to continue in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ganyu
Lianyungang, Jiangsu, 222100, China
Taixing
Taizhou, Jiangsu, 225400, China
Sheyang
Yancheng, Jiangsu, 224300, China
Biospecimen
Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after the first vaccination. Throat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease for the detection of PCR assays and the isolation of EV71.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feng-Cai Zhu, BS
Jiangsu Center for Diseases Control and Prevention
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 4, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2014
Study Completion
October 1, 2014
Last Updated
May 26, 2022
Record last verified: 2015-05