NCT04111432

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

July 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

September 29, 2019

Last Update Submit

July 26, 2021

Conditions

Hand, Foot and Mouth Disease

Keywords

Inactivated Enterovirus Type 71 (EV71) VaccineConcomitant vaccinationSafetyImmunogenicityInfant

Outcome Measures

Primary Outcomes (1)

  • The seroconversion rates（SCR） of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines

    Immunogenicity indicator

    30 days after two dose of EV71 vaccines

Secondary Outcomes (11)

  • The seroconversion rates（SCR） of the Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine

    60 days after one dose of MMR vaccine

  • The seroconversion rates（SCR） of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine

    30 days after one dose of Encephalitis B vaccine

  • EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines

    30 days after two dose of EV71 vaccines

  • The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines

    30 days after two dose of EV71 vaccines

  • Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine

    60 days after one dose of MMR vaccine

  • +6 more secondary outcomes

Study Arms (3)

Group I-EV71 and EPI vaccines Concomitant administration

EXPERIMENTAL

EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

Biological: Concomitant administration of EV71vaccine with EPI vaccines

Group II-EPI vaccine only Single injection of EPI vaccine:

ACTIVE COMPARATOR

measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

Biological: Single injection of EPI vaccine

Group III-EV71 vaccine only EV71 Vaccine only

ACTIVE COMPARATOR

the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively

Biological: EV71 Vaccine only

Interventions

Concomitant administration of EV71vaccine with EPI vaccinesBIOLOGICAL

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.

Group I-EV71 and EPI vaccines Concomitant administration
Single injection of EPI vaccineBIOLOGICAL

The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.

Group II-EPI vaccine only Single injection of EPI vaccine:
EV71 Vaccine onlyBIOLOGICAL

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Group III-EV71 vaccine only EV71 Vaccine only

Eligibility Criteria

Age8 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteer aged ≥ 8 months;
  • Proven legal identity;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

You may not qualify if:

  • Prior vaccination with EV71 vaccine;
  • Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
  • Prior vaccination with Encephalitis B vaccine；
  • Cannot be vaccinated with both arms at the same time；
  • History of hand，foot and mouth disease;
  • History of measles or mumps or rubella or encephalitis B；
  • 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;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • Autoimmune diseases or immunodeficiency/immunosuppression;
  • Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
  • History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • 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) in the past 6 months;
  • Receipt of any of the following products:
  • Blood product within 3 months prior to study entry;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanbin District Center for Disease Control and Prevention

Ankang, Shaanxi, 725000, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Shaobai Zhang

    Shaanxi Provincal Center for Disease Control and Preventione

    PRINCIPAL INVESTIGATOR

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 29, 2019

First Posted

October 1, 2019

Study Start

July 26, 2019

Primary Completion

November 25, 2019

Study Completion

March 25, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

CN(1)