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

September 22, 2021 updated by: Sinovac Research and Development Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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) 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);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The seroconversion rates (SCRs) of susceptible subjects in each group
Time Frame: 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.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidences of adverse events (AEs) of each group
Time Frame: 28 days
AEs occurred within 28 days after injection will be collected.
28 days
The incidences of serious adverse events (SAEs) of each group
Time Frame: 28 days
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
Time Frame: 28 days
Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.
28 days
The overall SCRs of each group
Time Frame: 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.
28 days
The overall post-immune GMTs of each group
Time Frame: 28 days
The GMTs of all the subjects in each group.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Research and Development Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-MUMPS-3001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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