Clinical trial NCT04133584: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Influenza
Hand, Foot and Mouth Disease
Keywords: Immunogenicity
Safety
Enterovirus 71 Vaccine
seasonal influenza vaccine
Lead sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
Collaborators: name: China National Biotec Group Company Limited
First posted: 2019-10-21
Enrollment: 1134
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

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.

Primary outcomes:
measure: immunogenicity evaluation
timeFrame: change from baseline antibody concentration at 28 days after the last dose
Secondary outcomes:
measure: safety evaluation: The occurrence of adverse events
timeFrame: up to 30 days after every injection
Other outcomes:
Locations:
city: Lishui
country: China
facility: Liandu Center for Disease Control and Prevention
state: Zhejiang
Study officials:
References: