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

Zhejiang Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 4

Conditions: Seasonal Influenza; Hand, Foot and Mouth Disease

Treatments: Biological: EV71 +SIV; Biological: SIV; Biological: EV71

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04133584

ZJCDC20190918

Details and patient eligibility

About

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)

Full 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

Enrollment: 1,134 patients

Sex: All

Ages: 6 to 11 months old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,134 participants in 3 patient groups

Group 1 EV71 +SIV

Experimental group

Description:

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Treatment:

Biological: EV71 +SIV

Group 2 EV71

Active Comparator group

Description:

Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart

Treatment:

Biological: EV71

Group 3 SIV

Active Comparator group

Description:

Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart

Treatment:

Biological: SIV