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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.
  Purpose
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.

Condition Intervention Phase
Mumps Biological: investigational live attenuated mumps vaccine Biological: control live attenuated mumps vaccine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Sinovac (Dalian) Vaccine Technology Co., Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1150
Study Start Date: January 2016
Study Completion Date: July 15, 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group
  • Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
  • Intervention: investigational live attenuated mumps vaccine;
Biological: investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Active Comparator: Control Group
  • Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
  • Intervention: control live attenuated mumps vaccine;
Biological: control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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);
  Contacts and Locations
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): NCT02692599


Locations
China, Hebei
Dingxing County Center for Disease Control and Prevention
Baoding, Hebei, China, 072650
Sponsors and Collaborators
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Investigators
Principal Investigator: Jingchen Ma Hubei Provincial Center for Disease Control and Prevention
  More Information

Responsible Party: Sinovac (Dalian) Vaccine Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT02692599     History of Changes
Other Study ID Numbers: PRO-MUMPS-3001
First Submitted: February 23, 2016
First Posted: February 26, 2016
Last Update Posted: October 26, 2017
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sinovac (Dalian) Vaccine Technology Co., Ltd.:
live attenuated mumps vaccine
safety
immunogenicity
infant

Additional relevant MeSH terms:
Mumps
Rubulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs