Overview

This trial is active, not recruiting.

Condition mumps
Treatments investigational live attenuated mumps vaccine, control live attenuated mumps vaccine
Phase phase 3
Sponsor Sinovac (Dalian) Vaccine Technology Co., Ltd.
Start date January 2016
End date March 2016
Trial size 1150 participants
Trial identifier NCT02692599, PRO-MUMPS-3001

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; Intervention: investigational live attenuated mumps vaccine;
investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
(Active Comparator)
Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; Intervention: control live attenuated mumps vaccine;
control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Primary Outcomes

Measure
The seroconversion rates (SCRs) of susceptible subjects in each group
time frame: 28 days

Secondary Outcomes

Measure
The incidences of adverse events (AEs) of each group
time frame: 28 days
The incidences of serious adverse events (SAEs) of each group
time frame: 28 days
The post-immune geometric mean titers (GMTs) of susceptible subjects in each group
time frame: 28 days
The overall SCRs of each group
time frame: 28 days
The overall post-immune GMTs of each group
time frame: 28 days

Eligibility Criteria

Male or female participants from 8 months up to 18 months old.

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:
    • Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
    • Any live attenuated vaccine within 28 days prior to study entry;
    • Any other investigational medicine(s) within 30 days prior to study entry;
    • Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
    • 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):
    • Receipt of any other investigational or unregistered product (drug or vaccine);
    • 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;
    • Receipt of immunoglobulin and/or blood product;
    • Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);

Additional Information

Official title A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
Principal investigator Jingchen Ma
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Sinovac (Dalian) Vaccine Technology Co., Ltd..