The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)

The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

Study Overview

• Status: Completed
• Conditions: Seasonal Influenza; Hand, Foot and Mouth Disease
• Intervention / Treatment: Biological: EV71 +SIV; Biological: EV71; Biological: SIV

Detailed Description

Main subjects:

The seroconversion rate for each antigen when EV71 is administrated with SIV

Secondary subjects:

The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV

• Study Type: Interventional
• Enrollment (Actual): 1134
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Lishui, Zhejiang, China
      • Liandu Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
• Participant is aged ≥ 6 month to <12 months.
• Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
• Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
• Body temperature ≤ 37.0#.

Exclusion Criteria:

• Known allergy to any constituent of the vaccine.

  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
  • Known bleeding disorder.
  • Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
  • Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
  • An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
  • Participation in any other intervention clinical trial.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 EV71 +SIV; Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart	Biological: EV71 +SIV; Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
Active Comparator: Group 2 EV71; Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart	Biological: EV71; Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
Active Comparator: Group 3 SIV; Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart	Biological: SIV; Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immunogenicity evaluation	The positive rate of antibody	change from baseline antibody concentration at 28 days after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety evaluation: The occurrence of adverse events	The occurrence of adverse events	up to 30 days after every injection

Collaborators and Investigators

• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
• Collaborators: China National Biotec Group Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; seasonal influenza vaccine; Enterovirus 71 Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Stomatognathic Diseases; Picornaviridae Infections; Orthomyxoviridae Infections; Coxsackievirus Infections; Influenza, Human; Mouth Diseases; Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease
• Other Study ID Numbers: ZJCDC20190918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No