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

• ClinicalTrials.gov Identifier: NCT04133584
• Recruitment Status: Recruiting
• First Posted: October 21, 2019
• Last Update Posted: October 21, 2019
• Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
• Collaborator: China National Biotec Group Company Limited
• Information provided by (Responsible Party): Zhejiang Provincial Center for Disease Control and Prevention

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Seasonal Influenza; Hand, Foot and Mouth Disease	Biological: EV71 +SIV; Biological: EV71; Biological: SIV	Phase 4

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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)
• Actual Study Start Date: September 16, 2019
• Estimated Primary Completion Date: April 30, 2020
• Estimated Study Completion Date: April 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 1 EV71 +SIV; Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart	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.
Active Comparator: Group 2 EV71; Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart	Biological: EV71; Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
Active Comparator: Group 3 SIV; Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart	Biological: SIV; Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last

Outcome Measures

Primary Outcome Measures :

1. immunogenicity evaluation [ Time Frame: change from baseline antibody concentration at 28 days after the last dose ]
   The positive rate of antibody

Secondary Outcome Measures :

1. safety evaluation: The occurrence of adverse events [ Time Frame: up to 30 days after every injection ]
   The occurrence of adverse events

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 11 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Chen Yaping, Master; +86-571-87115172; ypchen@cdc.zj.cn

Locations

China, Zhejiang

Liandu Center for Disease Control and Prevention; Recruiting

Lishui, Zhejiang, China

Contact: chen yaping, master 86-571-87115172 ypchen@cdc.zj

Sponsors and Collaborators

Zhejiang Provincial Center for Disease Control and Prevention

China National Biotec Group Company Limited

More Information

• Responsible Party: Zhejiang Provincial Center for Disease Control and Prevention
• ClinicalTrials.gov Identifier: NCT04133584
• Other Study ID Numbers: ZJCDC20190918
• First Posted: October 21, 2019
• Last Update Posted: October 21, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhejiang Provincial Center for Disease Control and Prevention:

Immunogenicity; Safety; Enterovirus 71 Vaccine; seasonal influenza vaccine

Additional relevant MeSH terms:

Influenza, Human; Enterovirus Infections; Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Stomatognathic Diseases; Coxsackievirus Infections