Clincosm LogoSign in Get a demo

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

Sponsor
Sinovac Biotech Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04111432
Collaborator
Shaanxi Provincial Center for Disease Control and Prevention (Other)
372
Enrollment
1
Location
3
Arms
8
Actual Duration (Months)
46.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Concomitant administration of EV71vaccine with EPI vaccines
  • Biological: Single injection of EPI vaccine
  • Biological: EV71 Vaccine only
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 26, 2019
Actual Primary Completion Date :
Nov 25, 2019
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I-EV71 and EPI vaccines Concomitant administration

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

Biological: Concomitant administration of EV71vaccine with EPI vaccines
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.
Active Comparator: Group II-EPI vaccine only Single injection of EPI vaccine:

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

Biological: Single injection of EPI vaccine
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.
Active Comparator: Group III-EV71 vaccine only EV71 Vaccine only

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

Biological: EV71 Vaccine only
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Outcome Measures

Primary Outcome Measures

  1. The seroconversion rates（SCR） of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines [30 days after two dose of EV71 vaccines]

    Immunogenicity indicator

Secondary Outcome Measures

  1. 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 [60 days after one dose of MMR vaccine]

    Immunogenicity indicator

  2. The seroconversion rates（SCR） of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine [30 days after one dose of Encephalitis B vaccine]

    Immunogenicity indicator

  3. EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines [30 days after two dose of EV71 vaccines]

    Immunogenicity indicator

  4. The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines [30 days after two dose of EV71 vaccines]

    Immunogenicity indicator

  5. Measles IgG antibody，Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine [60 days after one dose of MMR vaccine]

    Immunogenicity indicator

  6. 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 [60 days after one dose of MMR vaccine]

    Immunogenicity indicator

  7. The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine [30 days after one dose of Encephalitis B vaccine]

    Immunogenicity indicator

  8. The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine [30 days after one dose of Encephalitis B vaccine]

    Immunogenicity indicator

  9. Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose [7 days or 14 days after each dose of injection]

    Safety indicator

  10. The incidences of adverse reactions after each does [0-30 days after each dose]

    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.

  11. Incidence of serious adverse events (SAEs) during the period of safety monitoring [0-30 days after each dose]

    Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Months and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanbin District Center for Disease Control and Prevention Ankang Shaanxi China 725000

Sponsors and Collaborators

  • Sinovac Biotech Co., Ltd
  • Shaanxi Provincial Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Shaobai Zhang, Shaanxi Provincal Center for Disease Control and Preventione

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT04111432
Other Study ID Numbers:
  • EV71-SN-2019-01
First Posted:
Oct 1, 2019
Last Update Posted:
Jul 29, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sinovac Biotech Co., Ltd
Inactivated Enterovirus Type 71 (EV71) Vaccine
Concomitant vaccination
Safety
Immunogenicity
Infant
Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Vaccines

Study Results

No Results Posted as of Jul 29, 2021