The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Season… (NCT04133584) | Clinical Trial Compass
CompletedPhase 4
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
China1,134 participantsStarted 2019-09-16
Plain-language 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)
Who can participate
Age range6 Months – 11 Months
SexALL
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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.
What they're measuring
1
immunogenicity evaluation
Timeframe: change from baseline antibody concentration at 28 days after the last dose
Trial details
NCT IDNCT04133584
SponsorZhejiang Provincial Center for Disease Control and Prevention