Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
A Phase IV Open-labelled, Single-centered, Stratified-randomized Clinical Trial in Zhejiang Province to Evaluate the Safety and Immunogenicity of EV71 Vaccine Developed by Sinovac Biotech Co., Ltd.
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 16, 2017
CompletedFirst Submitted
Initial submission to the registry
September 7, 2017
CompletedFirst Posted
Study publicly available on registry
September 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedJanuary 2, 2019
December 1, 2018
2 months
September 7, 2017
December 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination
Immunogenicity indicator
30 days
Secondary Outcomes (6)
The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination
10,20,and 30 days
The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination
10, 20,30,and 60 days
GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination
10,20，30，and 60 days
Incidence of unsolicited local or systemic adverse events within 3 days after each dose
3 days
Incidence of unsolicited adverse events within 30 days after each dose
30 days
- +1 more secondary outcomes
Study Arms (3)
EV71 vaccine & blood sampling (0, 10,60)
EXPERIMENTALThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 10, and 60 respectively for EV71 neutralizing antibody detection.
EV71 vaccine & blood sampling (0, 20,60)
EXPERIMENTALThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 20, and 60 respectively for EV71 neutralizing antibody detection.
EV71 vaccine& blood sampling (0, 30, 60)
EXPERIMENTALThis group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 30, and 60 respectively for EV71 neutralizing antibody detection.
Interventions
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
Eligibility Criteria
You may qualify if:
- Healthy volunteers aged 6-35 months old
- Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
- Proven legal identity
You may not qualify if:
- For subjects with any of the following conditions, vaccination should not be administrated:
- History of hand foot and mouth disease
- Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, pain, etc
- Severe chronic diseases
- Thrombocytopenia or hemorrhagic disease
- Immunodeficiency disease or receipt of immunosuppressant treatment
- Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome)
- Acute disease or acute stage of chronic disease prior to the study entry
- History of thyroidectomy, thyroid disease within 12 months prior to the study entry
- Asplenia or functional asplenia
- Axillary temperature \>37.0 ℃
- Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators
- Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:
- Any serious adverse event that has a causal relationship with the investigated vaccine
- Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shangyu District Center for Disease Control and Prevention
Shaoxing, Zhejiang, 312300, China
Related Publications (1)
Wang S, Zeng J, Zhang X, Gan Z, Fan J, Chen Y, Liang Z, Hu X, Zeng G, Lv H. Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination. Hum Vaccin Immunother. 2020 Jul 2;16(7):1595-1601. doi: 10.1080/21645515.2020.1711678. Epub 2020 Jan 24.
PMID: 31977278DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huakun Lv
Zhejiang Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2017
First Posted
September 11, 2017
Study Start
July 16, 2017
Primary Completion
September 15, 2017
Study Completion
September 15, 2017
Last Updated
January 2, 2019
Record last verified: 2018-12