Clinical trial NCT02692599: Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
Official title: A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mumps
Keywords: live attenuated mumps vaccine
safety
immunogenicity
infant
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 1150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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);

Primary outcomes:
measure: The seroconversion rates (SCRs) of susceptible subjects in each group
timeFrame: 28 days
Secondary outcomes:
measure: The incidences of adverse events (AEs) of each group
timeFrame: 28 days
measure: The incidences of serious adverse events (SAEs) of each group
timeFrame: 28 days
measure: The post-immune geometric mean titers (GMTs) of susceptible subjects in each group
timeFrame: 28 days
measure: The overall SCRs of each group
timeFrame: 28 days
measure: The overall post-immune GMTs of each group
timeFrame: 28 days
Other outcomes:
Locations:
city: Baoding
country: China
facility: Dingxing County Center for Disease Control and Prevention
state: Hebei
Study officials:
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Jingchen Ma
role: PRINCIPAL_INVESTIGATOR
References: