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Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Concomitant administration of EV71vaccine with EPI vaccines
Single injection of EPI vaccine
EV71 Vaccine only
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease focused on measuring Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, Safety, Immunogenicity, Infant

Eligibility Criteria

8 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteer aged ≥ 8 months;
  • Proven legal identity;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study.

Exclusion Criteria:

  • Prior vaccination with EV71 vaccine;
  • Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components;
  • Prior vaccination with Encephalitis B vaccine;
  • Cannot be vaccinated with both arms at the same time;
  • History of hand,foot and mouth disease;
  • History of measles or mumps or rubella or encephalitis B;
  • Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • Autoimmune diseases or immunodeficiency/immunosuppression;
  • Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis;
  • History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months;
  • Receipt of any of the following products:

    1. Blood product within 3 months prior to study entry;
    2. Any live attenuated vaccine within 14 days prior to study entry;
    3. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
    4. Any other study drugs within 30 days prior to study entry;
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Axillary temperature > 37.0#;
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.

Sites / Locations

  • Hanbin District Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group I-EV71 and EPI vaccines Concomitant administration

Group II-EPI vaccine only Single injection of EPI vaccine:

Group III-EV71 vaccine only EV71 Vaccine only

Arm Description

EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30

the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively

Outcomes

Primary Outcome Measures

The seroconversion rates(SCR) of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Immunogenicity indicator

Secondary Outcome Measures

The seroconversion rates(SCR) of the Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Immunogenicity indicator
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Immunogenicity indicator
Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Immunogenicity indicator
The Geometric mean titer (GMT) of Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Safety indicator
The incidences of adverse reactions after each does
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 or day 0-14 were reported. Unsolicited adverse events on day 0-30 were also reported.
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose

Full Information

First Posted
September 29, 2019
Last Updated
July 26, 2021
Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Shaanxi Provincial Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04111432
Brief Title
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines
Official Title
A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Measles, Mumps, and Rubella Combined Live Attenuated Vaccine/ Encephalitis Live Attenuated Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 26, 2019 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Shaanxi Provincial Center for Disease Control and Prevention

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.
Detailed Description
This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety andimmunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. 360 healthy infants of 8 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)&measles mumps, and rubella combined live attenuated vaccine on day 0 and EV71 vaccine (second dose)&encephalitis live attenuated vaccine on day 30. The group II receive measles mumps, and rubella combined live attenuated vaccine on day 0 and encephalitis live attenuated vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, Safety, Immunogenicity, Infant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I-EV71 and EPI vaccines Concomitant administration
Arm Type
Experimental
Arm Description
EV71 Vaccine (intramuscular injection,0.5ml,first dose)/measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and EV71 Vaccine (intramuscular injection, 0.5ml,second dose)/ encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Arm Title
Group II-EPI vaccine only Single injection of EPI vaccine:
Arm Type
Active Comparator
Arm Description
measles mumps, and rubella combined live attenuated vaccine (subcutaneous injection,0.5ml) on day 0 and encephalitis live attenuated vaccine (subcutaneous injection, 0.5ml) on day 30
Arm Title
Group III-EV71 vaccine only EV71 Vaccine only
Arm Type
Active Comparator
Arm Description
the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 andday 30 respectively
Intervention Type
Biological
Intervention Name(s)
Concomitant administration of EV71vaccine with EPI vaccines
Intervention Description
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Intervention Type
Biological
Intervention Name(s)
Single injection of EPI vaccine
Intervention Description
The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
Intervention Type
Biological
Intervention Name(s)
EV71 Vaccine only
Intervention Description
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Primary Outcome Measure Information:
Title
The seroconversion rates(SCR) of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Description
Immunogenicity indicator
Time Frame
30 days after two dose of EV71 vaccines
Secondary Outcome Measure Information:
Title
The seroconversion rates(SCR) of the Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Description
Immunogenicity indicator
Time Frame
60 days after one dose of MMR vaccine
Title
The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Description
Immunogenicity indicator
Time Frame
30 days after one dose of Encephalitis B vaccine
Title
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Description
Immunogenicity indicator
Time Frame
30 days after two dose of EV71 vaccines
Title
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Description
Immunogenicity indicator
Time Frame
30 days after two dose of EV71 vaccines
Title
Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Description
Immunogenicity indicator
Time Frame
60 days after one dose of MMR vaccine
Title
The Geometric mean titer (GMT) of Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Description
Immunogenicity indicator
Time Frame
60 days after one dose of MMR vaccine
Title
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Description
Immunogenicity indicator
Time Frame
30 days after one dose of Encephalitis B vaccine
Title
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Description
Immunogenicity indicator
Time Frame
30 days after one dose of Encephalitis B vaccine
Title
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Description
Safety indicator
Time Frame
7 days or 14 days after each dose of injection
Title
The incidences of adverse reactions after each does
Description
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 or day 0-14 were reported. Unsolicited adverse events on day 0-30 were also reported.
Time Frame
0-30 days after each dose
Title
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Description
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose
Time Frame
0-30 days after each dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteer aged ≥ 8 months; Proven legal identity; Guardians of the participants should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study. Exclusion Criteria: Prior vaccination with EV71 vaccine; Prior vaccination with MMR vaccine or vaccine including mumps or measles or mumps or rubella vaccine components; Prior vaccination with Encephalitis B vaccine; Cannot be vaccinated with both arms at the same time; History of hand,foot and mouth disease; History of measles or mumps or rubella or encephalitis B; Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria,difficulty in breathing, angioneurotic edema, pain, etc; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc; Autoimmune diseases or immunodeficiency/immunosuppression; Severe neurological disorders (epilepsy, convulsions or convulsions) or psychosis; History of thyroidectomy, absence of spleen, functional absence of spleen, and any circumstances leading to absence of spleen or splenectomy; Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders; Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) in the past 6 months; Receipt of any of the following products: Blood product within 3 months prior to study entry; Any live attenuated vaccine within 14 days prior to study entry; Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; Any other study drugs within 30 days prior to study entry; Acute disease or acute stage of chronic disease within 7 days prior to study entry; Axillary temperature > 37.0#; Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaobai Zhang
Organizational Affiliation
Shaanxi Provincal Center for Disease Control and Preventione
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanbin District Center for Disease Control and Prevention
City
Ankang
State/Province
Shaanxi
ZIP/Postal Code
725000
Country
China

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

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