Efficacy Trial of a Commercial EV71 Vaccine

NCT03903926 | Completed Phase 4

• 1 other identifier: PRO-EV71-4013
• Study Type: interventional
• Target: 15,500
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Hand, Foot and Mouth Disease

Keywords

EV71 vaccine; Efficacy; Seroprotective correlates

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects

  Within 6 months after each dose injection

• The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects

  Through study completion, an average of 1 year

• The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects

  During the study period, 2 months after the study beginning

• The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects

  During the study period, 2 months after the study beginning

• The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects

  30 days after two doses

Study Arms (3)

Cohort one

EXPERIMENTAL

5000 volunteers (6-35 months)-EV71 vaccine

Biological: 5000 volunteers (6-35 months)-EV71 vaccine

Cohort two

NO INTERVENTION

10000 unvaccinated volunteers (6-35 months)

Cohort three

NO INTERVENTION

500 unvaccinated volunteers (36-71 months)

Interventions

5000 volunteers (6-35 months)-EV71 vaccine BIOLOGICAL

two doses EV71 vaccines will be administrated on day 0, 30 respectively

Cohort one

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Songzi Center for Disease Control and Prevention

Jingzhou, Hubei, 434200, China

Location

Xiantao Center for Disease Control and Prevention

Xiantao, Hubei, 433000, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xuhua Guan, Doctor

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 4, 2019
• Study Start: March 26, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 30, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

CN (2)