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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04133584

Enrollment

1134

Registered

2019-10-21

Start date

2019-09-16

Completion date

2021-11-30

Last updated

2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand, Foot and Mouth Disease, Seasonal Influenza

Keywords

Immunogenicity, Safety, Enterovirus 71 Vaccine, seasonal influenza vaccine

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

Interventions

BIOLOGICALEV71 +SIV

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

BIOLOGICALEV71

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

BIOLOGICALSIV

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 11 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
immunogenicity evaluation	change from baseline antibody concentration at 28 days after the last dose	The positive rate of antibody

Secondary

Measure	Time frame	Description
safety evaluation: The occurrence of adverse events	up to 30 days after every injection	The occurrence of adverse events

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026