Efficacy Trial of a Commercial EV71 Vaccine

Hand, Foot and Mouth Disease Clinical Trial

Official title:

Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903926
• Other study ID #: PRO-EV71-4013
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: July 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies

Description:

This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15500
• Est. completion date: October 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 71 Months

Eligibility

Inclusion Criteria:

• Volunteers aged 6-71 months;

• Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense;

• Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment;

• Complying with the requirement of the study protocol;

Exclusion Criteria:

• History of HFMD prior to the study entry;

• Prior vaccination with EV71 vaccine;

• History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ;

• Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group);

• Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group);

• Autoimmune disease or immunodeficiency/immunosuppressive (only for 6-35 months old subjects of the vaccinated group) ;

• History of asthma, angioedema, diabetes or malignancy (only for 6-35 months old subjects of the vaccinated group);

• Acute disease or acute stage of chronic disease within 7 days prior to study entry (only for 6-35 months old subjects of the vaccinated group);

• Axillary temperature > 37.0 Celsius (only for 6-35 months old subjects of the vaccinated group);

• Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

Biological:
• 5000 volunteers (6-35 months)-EV71 vaccine
two doses EV71 vaccines will be administrated on day 0, 30 respectively

Locations

Country	Name	City	State
China	Songzi Center for Disease Control and Prevention	Jingzhou	Hubei
China	Xiantao Center for Disease Control and Prevention	Xiantao	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of two doses EV71 vaccine in the 6-35 months old subjects	Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%	During the case monitoring period of 1 year
Primary	The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects	Immune correlates of protection	Through study completion, an average of 1 year
Secondary	The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects	Safety index	Within 6 months after each dose injection
Secondary	The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects	Immune correlates of protection	Through study completion, an average of 1 year
Secondary	The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects	Serum epidemiological index	During the study period, 2 months after the study beginning
Secondary	The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects	Serum epidemiological index	During the study period, 2 months after the study beginning
Secondary	The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects	Immunogenicity index	30 days after two doses
Secondary	The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects	Immunogenicity index	30 days after two doses
Secondary	Proportions of various pathogens in the confirmed HFMD cases	Pathogen spectrum index	Through study completion, an average of 1 year