- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04111432
Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines
July 26, 2021 updated by: Sinovac Biotech Co., Ltd
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
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
372
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
-
Ankang, Shaanxi, China, 725000
- Hanbin District Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 months and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
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
|
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The seroconversion rates(SCR) of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Time Frame: 30 days after two dose of EV71 vaccines
|
Immunogenicity indicator
|
30 days after two dose of EV71 vaccines
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 60 days after one dose of MMR vaccine
|
Immunogenicity indicator
|
60 days after one dose of MMR vaccine
|
The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Time Frame: 30 days after one dose of Encephalitis B vaccine
|
Immunogenicity indicator
|
30 days after one dose of Encephalitis B vaccine
|
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Time Frame: 30 days after two dose of EV71 vaccines
|
Immunogenicity indicator
|
30 days after two dose of EV71 vaccines
|
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Time Frame: 30 days after two dose of EV71 vaccines
|
Immunogenicity indicator
|
30 days after two dose of EV71 vaccines
|
Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Time Frame: 60 days after one dose of MMR vaccine
|
Immunogenicity indicator
|
60 days after one dose of MMR vaccine
|
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
Time Frame: 60 days after one dose of MMR vaccine
|
Immunogenicity indicator
|
60 days after one dose of MMR vaccine
|
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Time Frame: 30 days after one dose of Encephalitis B vaccine
|
Immunogenicity indicator
|
30 days after one dose of Encephalitis B vaccine
|
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Time Frame: 30 days after one dose of Encephalitis B vaccine
|
Immunogenicity indicator
|
30 days after one dose of Encephalitis B vaccine
|
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Time Frame: 7 days or 14 days after each dose of injection
|
Safety indicator
|
7 days or 14 days after each dose of injection
|
The incidences of adverse reactions after each does
Time Frame: 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.
|
0-30 days after each dose
|
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Time Frame: 0-30 days after each dose
|
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose
|
0-30 days after each dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shaobai Zhang, Shaanxi Provincal Center for Disease Control and Preventione
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 26, 2019
Primary Completion (ACTUAL)
November 25, 2019
Study Completion (ACTUAL)
March 25, 2020
Study Registration Dates
First Submitted
September 29, 2019
First Submitted That Met QC Criteria
September 29, 2019
First Posted (ACTUAL)
October 1, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV71-SN-2019-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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