Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of Two Different Commercial EV71 Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03873740
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Shandong Provincal Center for Disease Control and Prevention
Rushan city Center for Disease Control and Prevention
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: EV71 inactived vaccine(Vero cells) Biological: EV71 inactived vaccine(Human diploid cells) Phase 4

Detailed Description:
This study is a opened,randomized and controlled phase Ⅳ clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months. EV71 inactived vaccines(Vero cells)was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid cells)was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.300 infants aged between 6-35 months will be randomly assigned into experimental group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived vaccines(Vero cells)on day 0 and 30. The experimental group 2 received two doses EV71 inactived vaccines (Human diploid cells)on day 0 and 30. The experimental group 3 received one dose EV71 inactived vaccines (Vero cells)on day 0 and one dose EV71 inactived vaccines (Human diploid cells)on day 30.The experimental group 4 received one dose EV71 inactived vaccines (Human diploid cells)on day 0 and one dose EV71 inactived vaccines (Vero cells)on day 30. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose vaccination.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Opened,Randomized and Controlled Trial to Evaluate the Immunity and Safety of Sequential Vaccination of Two Different Commercial EV71 Inactived Vaccines in Healthy Infants Aged 6-35 Months
Actual Study Start Date : November 6, 2018
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 23, 2019

Arm Intervention/treatment
Experimental: Single vaccine group A
This group receive two doses injection of EV71 inactived vaccines(Vero cells) on Day 0 and 30, and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Sinovac Vaccine Technology Co., Ltd.
Biological: EV71 inactived vaccine(Vero cells)
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.

Experimental: Single vaccine group B
This group receive two doses injection of EV71 inactived vaccines(human diploid cells)on Day 0 and 30, two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.The vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Biological: EV71 inactived vaccine(Human diploid cells)
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Experimental: Sequential vaccination group A
One dose injection of EV71 inactived vaccines(Vero cells) on Day 0,following one dose of EV71 vaccine(EV71 inactived vaccines(human diploid cells), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
Biological: EV71 inactived vaccine(Vero cells)
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.

Biological: EV71 inactived vaccine(Human diploid cells)
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.

Experimental: Sequential vaccination group B
One dose injection of EV71 inactived vaccines(human diploid cells)on Day 0,following one does of EV71 vaccine(Sinovac Vaccine Technology Co., Ltd), and two times of blood sampling on day of 0 and 60 respectively for EV71 neutralizing antibody detection.
Biological: EV71 inactived vaccine(Vero cells)
The EV71 inactived vaccine(Vero cells) was manufactured by Sinovac Biotech Co., Ltd.

Biological: EV71 inactived vaccine(Human diploid cells)
The EV71 inactived vaccine(Human diploid cells) was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.




Primary Outcome Measures :
  1. The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8. [ Time Frame: 30 days after two doses ]
    Subjects whose pre-immune EV71 antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune EV71 antibody level ≥ 4 folds are considered seroconverted


Secondary Outcome Measures :
  1. 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 were reported. Unsolicited adverse events on day 0-30 were also reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).

  2. The incidence of solicited local and general adverse events after each does [ Time Frame: 0-7 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 were reported. Each AE case will be reviewed by the investigator to determine whether or not it was an adverse reaction (The vaccination-related AE).

  3. 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.

  4. EV71 neutralizing antibody positive rate of each group after two doses. [ Time Frame: 30 days after two doses ]
    Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive.

  5. The Geometric mean titer (GMT) of the EV71 neutralizing antibody [ Time Frame: 30 days after two doses ]
    The GMT 30 days of each group after two doses.

  6. The geometric mean fold increase (GMI) of the EV71 neutralizing antibody [ Time Frame: 30 days after two doses ]
    The GMI 30 days of each group after two doses.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer aged 6-35 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;
  • History of hand,foot and mouth disease;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873740


Locations
Layout table for location information
China, Shandong
Rushan City Center for Disease Control and Prevention
Rushan, Shandong, China, 264500
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Shandong Provincal Center for Disease Control and Prevention
Rushan city Center for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: AIqiang Xu Shandong Provincal Center for Disease Control and Preventione

Layout table for additonal information
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03873740     History of Changes
Other Study ID Numbers: EV71-SD-2018-01
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Layout table for additional information
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
Sequential vaccination
Immunity
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs