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

Phase 3

Completed

• Conditions: Mumps
• Interventions: Biological: control live attenuated mumps vaccine; Biological: investigational live attenuated mumps vaccine

• Registration Number: NCT02692599
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Primary Completion: 2016-03
• Status Verified: 2016-04
• Study Completion: 2016-07-15
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	control live attenuated mumps vaccine	* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated mumps vaccine;
Experimental Group	investigational live attenuated mumps vaccine	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated mumps vaccine;

Primary Outcome Measures

Name	Time	Method
The seroconversion rates (SCRs) of susceptible subjects in each group	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

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

Trial Locations

Locations (1)

Dingxing County Center for Disease Control and Prevention; 🇨🇳 Baoding, Hebei, China