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Trial record 11 of 31 for:    sinovac | China

Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02692599
First Posted: February 26, 2016
Last Update Posted: October 26, 2017
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.
Information provided by (Responsible Party):
Sinovac (Dalian) Vaccine Technology Co., Ltd.
February 23, 2016
February 26, 2016
October 26, 2017
January 2016
March 2016   (Final data collection date for primary outcome measure)
The seroconversion rates (SCRs) of susceptible subjects in each group [ Time Frame: 28 days ]
Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.
Same as current
Complete list of historical versions of study NCT02692599 on ClinicalTrials.gov Archive Site
  • The incidences of adverse events (AEs) of each group [ Time Frame: 28 days ]
    AEs occurred within 28 days after injection will be collected.
  • The incidences of serious adverse events (SAEs) of each group [ Time Frame: 28 days ]
    SAEs occurred within 28 days after injection will be collected.
  • The post-immune geometric mean titers (GMTs) of susceptible subjects in each group [ Time Frame: 28 days ]
    Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.
  • The overall SCRs of each group [ Time Frame: 28 days ]
    Subjects whose pre-immune HI antibody level < 1:2 and post-immune antibody level ≥ 1:2, or those whose pre-immune antibody level ≥ 1:2 and the increase of post-immune HI antibody level ≥ 4 folds are considered seroconverted.
  • The overall post-immune GMTs of each group [ Time Frame: 28 days ]
    The GMTs of all the subjects in each group.
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.
This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Mumps
  • Biological: investigational live attenuated mumps vaccine
    The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
  • Biological: control live attenuated mumps vaccine
    The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
  • Experimental: Experimental Group
    • Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
    • Intervention: investigational live attenuated mumps vaccine;
    Intervention: Biological: investigational live attenuated mumps vaccine
  • Active Comparator: Control Group
    • Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
    • Intervention: control live attenuated mumps vaccine;
    Intervention: Biological: control live attenuated mumps vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1150
July 15, 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteer between 8 - 18 months old;
  • Proven legal identity;
  • Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;
  • Complying with the requirement of the study protocol;

Exclusion Criteria:

  • Axillaty temperature > 37.0 °C;
  • Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry;
  • Prior vaccination with mumps vaccine or with history of mumps infection;
  • History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) about vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • Receipt of any of the following products:

    1. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
    2. Any live attenuated vaccine within 28 days prior to study entry;
    3. Any other investigational medicine(s) within 30 days prior to study entry;
    4. Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
    5. 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) within 6 month prior to study entry;
  • Epilepsy (except febrile seizures), history of seizures or convulsions, or a family history of mental illness;
  • Autoimmune disease or immunodeficiency;
  • Congenital malformation, developmental disorders, or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders;
  • Severe malnutrition;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities);
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
  • Participants with the following conditions between day 0 - 28 of this study would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):

    1. Receipt of any other investigational or unregistered product (drug or vaccine);
    2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid;
    3. Receipt of immunoglobulin and/or blood product;
    4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
Sexes Eligible for Study: All
8 Months to 18 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02692599
PRO-MUMPS-3001
No
Not Provided
Plan to Share IPD: No
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Not Provided
Principal Investigator: Jingchen Ma Hubei Provincial Center for Disease Control and Prevention
Sinovac (Dalian) Vaccine Technology Co., Ltd.
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP