The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
Primary Purpose
Seasonal Influenza, Hand, Foot and Mouth Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
EV71 +SIV
EV71
SIV
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine
Eligibility Criteria
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.
Sites / Locations
- Liandu Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Group 1 EV71 +SIV
Group 2 EV71
Group 3 SIV
Arm Description
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart
Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Outcomes
Primary Outcome Measures
immunogenicity evaluation
The positive rate of antibody
Secondary Outcome Measures
safety evaluation: The occurrence of adverse events
The occurrence of adverse events
Full Information
NCT ID
NCT04133584
First Posted
September 18, 2019
Last Updated
July 12, 2022
Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT04133584
Brief Title
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Provincial Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza, Hand, Foot and Mouth Disease
Keywords
Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 EV71 +SIV
Arm Type
Experimental
Arm Description
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Arm Title
Group 2 EV71
Arm Type
Active Comparator
Arm Description
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart
Arm Title
Group 3 SIV
Arm Type
Active Comparator
Arm Description
Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 +SIV
Intervention Description
Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
Intervention Type
Biological
Intervention Name(s)
EV71
Intervention Description
Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
Intervention Type
Biological
Intervention Name(s)
SIV
Intervention Description
Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last
Primary Outcome Measure Information:
Title
immunogenicity evaluation
Description
The positive rate of antibody
Time Frame
change from baseline antibody concentration at 28 days after the last dose
Secondary Outcome Measure Information:
Title
safety evaluation: The occurrence of adverse events
Description
The occurrence of adverse events
Time Frame
up to 30 days after every injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Liandu Center for Disease Control and Prevention
City
Lishui
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
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