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

Seasonal Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04133584
• Other study ID #: ZJCDC20190918
• Status: Completed
• Phase: Phase 4
• Start date: September 16, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2022
• Source: Zhejiang Provincial Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1134
• Est. completion date: November 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 11 Months

Eligibility

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.

Related Conditions & MeSH terms

• Enterovirus Infections
• Hand, Foot and Mouth Disease
• Influenza, Human
• Mouth Diseases
• Seasonal Influenza

Intervention

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.
• EV71
Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
• SIV
Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Locations

Country	Name	City	State
China	Liandu Center for Disease Control and Prevention	Lishui	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Provincial Center for Disease Control and Prevention	China National Biotec Group Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunogenicity evaluation	The positive rate of antibody	change from baseline antibody concentration at 28 days after the last dose
Secondary	safety evaluation: The occurrence of adverse events	The occurrence of adverse events	up to 30 days after every injection