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

Sinovac

Status and phase

Completed

Phase 3

Conditions

Mumps

Treatments

Biological: Investigational live attenuated mumps vaccine

Biological: control live attenuated mumps vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT05065177

PRO-MUMPS-3001

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,140 patients

Sex

All

Ages

8 to 18 months old

Volunteers

Accepts Healthy Volunteers

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) to 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 (e.g., 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 (dosage of corticosteroid ≥ that in 0.5 mg prednisone per kg weight per day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid;
3. Receipt of immunoglobulin and/or other blood product;
4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);