Back to results

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

Primary Purpose

Enterovirus Infections, Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

EV71 vaccine and influenza vaccine

EV71 vaccine

influenza vaccine

About this trial

This is an interventional prevention trial for Enterovirus Infections focused on measuring EV71 vaccine, influenza vaccine, simultaneously administration

Eligibility Criteria

6 Months - 11 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

subjects aged from 6-11 months old at the date of recruitment;
with informed consent signed by parent(s) or guardians;
parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions;
subjects not receive any vaccination within 14 days at the date of recruitment;
subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;
subjects with no medical history of EV71 infection;
axillary temperature ≤37.0℃

Exclusion Criteria:

subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
allergic to any ingredient of vaccine or with allergy history to any vaccine;
subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
administration of immunoglobulins within 30 days prior to this study;
acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
have a clearly diagnosed history of thrombocytopenia or other coagulopathy,
may cause contraindications for subcutaneous injection;
any serious chronic illness, acute infectious diseases, or respiratory diseases;
severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
any kind of infectious, purulent, or allergic skin diseases;
any other factor that makes the investigator determines the subject is unsuitable for this study.

Sites / Locations

Zhejiang provincial center for disease control and prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group A

control group B

Arm Description

378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously.

378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart).

378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart).

Outcomes

Primary Outcome Measures

Seroconversion rate I

the rate of positive seroconversion against EV71

Seroconversion rate II

the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses

Geometric mean titer (GMT) I

Measure neutralizing antibody titers against EV71

Geometric mean titer (GMT) II

Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses

Secondary Outcome Measures

adverse events following vaccination

analyse the numbers and rates of participants who experience adverse events following immunization

Full Information

NCT ID

NCT04091880

First Posted

September 15, 2019

Last Updated

October 10, 2022

Sponsor

China National Biotec Group Company Limited

Collaborators

Zhejiang Provincial Center for Disease Control and Prevention, Henan Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd, Changchun Institute of Biological Products Co., Ltd., Peking University, National Institutes for Food and Drug Control, China

1. Study Identification

Unique Protocol Identification Number

NCT04091880

Brief Title

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

Official Title

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

September 26, 2019 (Actual)

Primary Completion Date

January 6, 2020 (Actual)

Study Completion Date

August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China National Biotec Group Company Limited

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Subjects will be recruited and divided into 3 groups: Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; Control Group A (378 subjects): EV71 vaccine only; Control Group B (378 subjects): influenza vaccine only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Detailed Description

To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B). 378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. 378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination. To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enterovirus Infections, Influenza

Keywords

EV71 vaccine, influenza vaccine, simultaneously administration

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

Arm Title

control group A

Arm Type

Active Comparator

Arm Description

378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart).

Arm Title

control group B

Arm Type

Active Comparator

Arm Description

378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart).

Intervention Type

Biological

Intervention Name(s)

EV71 vaccine and influenza vaccine

Intervention Description

simultaneously administrated with EV71 vaccine and influenza vaccine

Intervention Type

Biological

Intervention Name(s)

EV71 vaccine

Intervention Description

administrated with EV71 vaccine only

Intervention Type

Biological

Intervention Name(s)

influenza vaccine

Intervention Description

administrated with influenza vaccine only

Primary Outcome Measure Information:

Title

Seroconversion rate I

Description

the rate of positive seroconversion against EV71

Time Frame

Baseline (before vaccination) and 1 month after the last dose

Title

Seroconversion rate II

Description

the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses

Time Frame

Baseline (before vaccination ) and 1 month after the last dose

Title

Geometric mean titer (GMT) I

Description

Measure neutralizing antibody titers against EV71

Time Frame

Baseline (before vaccination) and 1 month after the last dose

Title

Geometric mean titer (GMT) II

Description

Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses

Time Frame

Baseline (before vaccination) and 1 month after the last dose

Secondary Outcome Measure Information:

Title

adverse events following vaccination

Description

analyse the numbers and rates of participants who experience adverse events following immunization

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

11 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: subjects aged from 6-11 months old at the date of recruitment; with informed consent signed by parent(s) or guardians; parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions; subjects not receive any vaccination within 14 days at the date of recruitment; subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine; subjects with no medical history of EV71 infection; axillary temperature ≤37.0℃ Exclusion Criteria: subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; allergic to any ingredient of vaccine or with allergy history to any vaccine; subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); administration of immunoglobulins within 30 days prior to this study; acute febrile disease(temperature ≥ 37.0°C) or infectious disease; have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; any serious chronic illness, acute infectious diseases, or respiratory diseases; severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications; any kind of infectious, purulent, or allergic skin diseases; any other factor that makes the investigator determines the subject is unsuitable for this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hanqing He

Organizational Affiliation

Zhejiang Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang provincial center for disease control and prevention

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310051

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

We'll reach out to this number within 24 hrs