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.

Study Overview

• Status: Completed
• Conditions: Mumps
• Intervention / Treatment: Biological: control live attenuated mumps vaccine; Biological: investigational live attenuated mumps 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.

• Study Type: Interventional
• Enrollment (Actual): 1150
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hebei
    • Baoding, Hebei, China, 072650
      • Dingxing County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The seroconversion rates (SCRs) of susceptible subjects in each group	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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidences of adverse events (AEs) of each group	AEs occurred within 28 days after injection will be collected.	28 days
The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 28 days after injection will be collected.	28 days
The post-immune geometric mean titers (GMTs) of susceptible subjects in each group	Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.	28 days
The overall SCRs of each group	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.	28 days
The overall post-immune GMTs of each group	The GMTs of all the subjects in each group.	28 days

Collaborators and Investigators

• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): July 15, 2016

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: safety; immunogenicity; infant; live attenuated mumps vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Paramyxoviridae Infections; Mononegavirales Infections; Salivary Gland Diseases; Rubulavirus Infections; Parotitis; Parotid Diseases; Mumps; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-MUMPS-3001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO