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Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05065177•Sinovac Research and Development Co., Ltd.

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

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

Yes

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;
+12 more criteria

Locations (1)

Dingxing County Center for Disease Control and Prevention

Dingxing, Hebei, China

Key Dates

Start Date

January 1, 2016

Primary Completion Date

March 1, 2016

Completion Date

April 1, 2016

Last Updated

October 1, 2021

Enrollment

1,140

ACTUAL participants

Conditions

Mumps

Interventions

Investigational live attenuated mumps vaccine

BIOLOGICAL

control live attenuated mumps vaccine

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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