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Completed

NCT Number: NCT04133584

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

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)

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Key information

Age range

6 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liandu Center for Disease Control and Prevention

Lishui, Zhejiang, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EV71 +SIV

Biological

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

EV71

Biological

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

SIV

Biological

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

Primary outcomes

  1. immunogenicity evaluation

    Time frame: change from baseline antibody concentration at 28 days after the last dose

    The positive rate of antibody

Secondary outcomes

  1. safety evaluation: The occurrence of adverse events

    Time frame: up to 30 days after every injection

    The occurrence of adverse events

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Other Gov

Collaborators

  • China National Biotec Group Company Limited

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2019
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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