Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months

NCT03909074 | Completed Phase 3

• 1 other identifier: PRO-EV71-3003
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Conditions

Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (2)

• The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8

  Subjects whose pre-immune antibody titer \< 1:8 and post-immune antibody titer ≥ 1:8, or those whose pre-immune antibody titer ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.

  30 days after two doses

• The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population

  The susceptible population refer to the subjects whose pre-immune antibody titer \<1:8

  30 days after two doses

Secondary Outcomes (4)

• The overall incidence of adverse reactions

  0-30 days after each dose

• The incidence of the serious adverse events (SAE)

  0-30 days after each dose

• The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:16, 1:32, and 1:64 respectively

  30 days after two doses

• The Geometric mean titer (GMT) of the EV71 neutralizing antibody

  30 days after two doses

Study Arms (3)

Experimental group

EXPERIMENTAL

36-71 months old children-experimental EV71 vaccine.

Biological: 36-71 months old children-experimental EV71 vaccine.

Vaccine-controlled group

ACTIVE COMPARATOR

36-71 months old children-control EV71 vaccine.

Biological: 36-71 months old children-control EV71 vaccine.

Age-controlled group

ACTIVE COMPARATOR

6-35 months old children-experimental EV71 vaccine.

Biological: 6-35 months old children-experimental EV71 vaccine.

Interventions

36-71 months old children-experimental EV71 vaccine. BIOLOGICAL

Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.

Experimental group

36-71 months old children-control EV71 vaccine. BIOLOGICAL

Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.

Vaccine-controlled group

6-35 months old children-experimental EV71 vaccine. BIOLOGICAL

Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.

Age-controlled group

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers ≥ 2 years old;
• Proven legal identity;
• Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment.

You may not qualify if:

• Prior vaccination with EV71 vaccine;
• History of hand, foot and mouth disease;
• History of allergy to any vaccine or vaccine ingredient, asthma, serious adverse reactions to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
• Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
• Autoimmune disease or immunodeficiency/immunosuppressive;
• Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
• History of thyroidectomy, no spleen and functional spleen;
• Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
• Receipt of any of the following products:
• Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry
• Blood products within 2 months prior to study entry
• Any other investigational products (drug or vaccine）within 30 days prior to study entry
• Any live attenuated vaccine within 14 days prior to study entry
• Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• Acute disease or acute stage of chronic disease within 7 days prior to study entry;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Yun County Center for Disease Control and Prevention

Lincang, Yunnan, 675800, China

Location

Related Publications (1)

• Zhang L, Gao F, Zeng G, Yang H, Zhu T, Yang S, Meng X, Mao Q, Liu X. Immunogenicity and Safety of Inactivated Enterovirus 71 Vaccine in Children Aged 36-71 Months: A Double-Blind, Randomized, Controlled, Non-inferiority Phase III Trial. J Pediatric Infect Dis Soc. 2021 Apr 30;10(4):440-447. doi: 10.1093/jpids/piaa129.

  PMID: 33269798 DERIVED

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

• Lifen Zhang, Master

  Yunnan Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 9, 2019
• Study Start: March 10, 2019
• Primary Completion: June 17, 2019
• Study Completion: November 13, 2019
• Last Updated: May 26, 2022

Record last verified: 2020-01

Locations

CN (1)