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

Phase 4

Completed

• Conditions: Seasonal Influenza; Hand, Foot and Mouth Disease
• Interventions: Biological: EV71; Biological: EV71 +SIV; Biological: SIV

• Registration Number: NCT04133584
• Lead Sponsor: Zhejiang Provincial Center for Disease Control and Prevention

Brief Summary

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)

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 Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Primary Completion: 2021-06-30
• Study Completion: 2021-11-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 EV71	EV71	Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart
Group 1 EV71 +SIV	EV71 +SIV	Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Group 3 SIV	SIV	Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Primary Outcome Measures

Name	Time	Method
immunogenicity evaluation	change from baseline antibody concentration at 28 days after the last dose	The positive rate of antibody

Secondary Outcome Measures

Name	Time	Method
safety evaluation: The occurrence of adverse events	up to 30 days after every injection	The occurrence of adverse events

Trial Locations

Locations (1)

Liandu Center for Disease Control and Prevention; 🇨🇳 Lishui, Zhejiang, China