The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School Students

January 5, 2024 updated by: Sinovac Biotech Co., Ltd

The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine Administrated Alone and Concomitantly With a Quadrivalent Inactivated Influenza Vaccine in Junior High School Students

This study is a randomized, controlled, open-label phase Ⅳ clinical trial of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the booster doses of a mumps vaccine administrated alone and concomitantly with a quadrivalent inactivated influenza vaccine in healthy junior high school students. And the cross-neutralization of mumps vaccine immune serum and mumps virus strains

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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 an open-lable, randomised, controlled phase Ⅳ clinical trial in healthy junior high school students to the immunogenicity and safety of the booster doses of a mumps vaccine (MV) administrated alone and concomitantly with a quadrivalent influenza vaccine (QIV) in healthy junior high school students. The experimental vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. A total of 400 healthy students will be enrolled, including 300 students who have received one dose of mumps-containing vaccine (MCV) before vaccination, and 100 students who have received two doses of mumps-containing vaccine before vaccination. 300 students with a history of 1 dose of MCV will be randomly divided into 3 groups in a ratio of 1:1:1, and will receive 1 dose of MV alone, 1 dose of QIV alone, or 1 dose of MV and 1 dose of QIV simultaneously. Students with a history of 2 doses of MCV received 1 dose of MV alone. Blood samples were collected before and 30 days after vaccination. Pre-vaccination blood samples were used to detect antibody levels of measles, mumps, influenza and varicella, and post-vaccination blood samples were used to detect mumps antibodies and/or influenza antibodies corresponding to the vaccination.

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.
400

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 4

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
    • Shaanxi
      • Xianyang, Shaanxi, China, 712099
        • Qindu Distric Center for Disease Prevention and Control
      • Xianyang, Shaanxi, China, 713199
        • Xingping Center for Disease Prevention and Control
      • Yulin, Shaanxi, China, 719054
        • Yuyang Distict Center for Disease Prevention and Control

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy junior high school students;
  • subjects and/or guardians who can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form)
  • Provision of valid identification.;
  • History of 1 or 2 doses of mumps-containing vaccine;

Exclusion Criteria:

  • History of mumps or have completed 3 doses of mumps-containing vaccine;
  • Receipt of the current seasonal influenza vaccine (except subjects in Arm 4)
  • History of asthma or allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition;
  • Autoimmune disease (such as systemic lupus erythematosus) or a state of immunodeficiency / immunosuppression (such as AIDS, after organ transplantation);
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, any condition resulting in asplenia or splenectomy;
  • Abnormal coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, topical corticosteroid therapy for acute uncomplicated dermatitis) within the past 6 months;
  • Receipt of blood products in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 28 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • Participation in other clinical trials before enrollment and during the follow-up period, or a plan to participate in other clinical trials within 3 months.
  • Any other factors that are unsuitable for participating in this clinical trial according to the investigator's judgment

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 Assignment
  • Masking: None (Open Label)

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: 1MCV: MV
100 students with a history of 1 dose of MCV will receive 1 dose of MV.
Biological: Mumps vaccine, Live (MV)
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
Experimental: 1MCV: QIV
100 students with a history of 1 dose of MCV will receive 1 dose of QIV.
Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.
Experimental: 1MCV: MV +QIV
100 students with a history of 1 dose of MCV will receive 1 dose of MV and 1 dose of QIV simultaneously.
Biological: Mumps vaccine, Live (MV)
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus
Biological: Influenza Vaccine, inactivated, quadrivlent(QIV)
0.5mL per dose, containing 4 strains of influenza virus recommended by the WHO, 15ug of each strain.
Experimental: 2MCV: MV
100 students with a history of 2 dose of MCV will receive 1 dose of MV.
Biological: Mumps vaccine, Live (MV)
0.5mL per dose,containing ≥3.7 lg CCID50 live mumps virus

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
Geometric mean concentrations (GMCs) of mumps antibody
Time Frame: 30 days after the vaccination of MV
GMC s of mumps antibody 30 days after the vaccination of MV
30 days after the vaccination of MV

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
Geometric mean increases (GMIs) of mumps antibody
Time Frame: 30 days after the vaccination of MV
Geometric mean increases (GMIs) of mumps antibody 30 days after the vaccination of MV
30 days after the vaccination of MV
Seroconversion rate of mumps antibody
Time Frame: 30 days after the vaccination of MV
Seroconversion rate of mumps antibody 30 days after the vaccination of MV
30 days after the vaccination of MV
Seropositivity rate of mumps antibody
Time Frame: 30 days after the vaccination of MV
Seropositivity rate of mumps antibody 30 days after the vaccination of MV
30 days after the vaccination of MV
Geometric mean titers (GMTs) of influenza antibody
Time Frame: 30 days after the vaccination of QIV
Geometric mean titers (GMTs) of influenza antibody 30 days after the vaccination of QIV
30 days after the vaccination of QIV
Geometric mean increases (GMIs) of influenza antibody
Time Frame: 30 days after the vaccination of QIV
Geometric mean increases (GMIs) of influenza antibody 30 days after the vaccination of QIV
30 days after the vaccination of QIV
Seroconversion rate of influenza antibody
Time Frame: 30 days after the vaccination of QIV
Seroconversion rate of influenza antibody 30 days after the vaccination of QIV
30 days after the vaccination of QIV
Seropositivity rate of influenza antibody
Time Frame: 30 days after the vaccination of QIV
Seropositivity rate of influenza antibody 30 days after the vaccination of QIV
30 days after the vaccination of QIV
Geometric mean concentrations (GMCs) of mumps antibody 30 days after the simultaneous vaccination of MV and QIV
Time Frame: 30 days after the simultaneous vaccination of MV and QIV
Geometric mean concentrations (GMCs) of mumps antibody
30 days after the simultaneous vaccination of MV and QIV
Geometric mean titers (GMTs) of influenza antibody 30 days after the simultaneous vaccination of MV and QIV
Time Frame: 30 days after the simultaneous vaccination of MV and QIV
Geometric mean titers (GMTs) of influenza antibody
30 days after the simultaneous vaccination of MV and QIV
Geometric mean increases (GMIs) of mumps antibody and influenza antibody
Time Frame: 30 days after the simultaneous vaccination of MV and QIV
Geometric mean increases (GMIs) of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
30 days after the simultaneous vaccination of MV and QIV
Seroconversion rate of mumps antibody and influenza antibody
Time Frame: 30 days after the simultaneous vaccination of MV and QIV
Seroconversion rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
30 days after the simultaneous vaccination of MV and QIV
Seropositivity rate of mumps antibody and influenza antibody
Time Frame: 30 days after the simultaneous vaccination of MV and QIV
Seropositivity rate of mumps antibody and influenza antibody 30 days after the simultaneous vaccination of MV and QIV
30 days after the simultaneous vaccination of MV and QIV
The incidence of adverse reactions 0-7 days after vaccination
Time Frame: 0-7 days after vaccination
The incidence of adverse reactions 0-7 days after vaccination
0-7 days after vaccination
The incidence of adverse reactions 0-14 days after vaccination
Time Frame: 0-14 days after vaccination
The incidence of adverse reactions 0-14 days after vaccination
0-14 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination
Time Frame: 0-30 days after vaccination
The incidence of adverse reactions 0-30 days after vaccination
0-30 days after vaccination
Geometric mean concentrations (GMCs) of measles antibody before vaccination
Time Frame: before vaccination
Geometric mean concentrations (GMCs) of measles antibody before vaccination
before vaccination
Geometric mean concentrations (GMCs) of rubella antibody before vaccination
Time Frame: before vaccination
Geometric mean concentrations (GMCs) of rubella antibody before vaccination
before vaccination
Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
Time Frame: before vaccination
Geometric mean titers (GMTs) of varicella-zostor antibody before vaccination
before vaccination
Geometric mean concentrations (GMCs) of mumps antibody before vaccination
Time Frame: before vaccination
Geometric mean concentrations (GMCs) of mumps antibody before vaccination
before vaccination
Geometric mean titers (GMTs) of influenza antibody before vaccination
Time Frame: before vaccination
Geometric mean titers (GMTs) of influenza antibody before vaccination
before vaccination
Seropositivity rate of measles antibody before vaccination
Time Frame: before vaccination
Seropositivity rate of measles antibody before vaccination
before vaccination
Seropositivity rate of rubella antibody before vaccination
Time Frame: before vaccination
Seropositivity rate of rubella antibody before vaccination
before vaccination
Seropositivity rate of varicella-zostor antibody before vaccination
Time Frame: before vaccination
Seropositivity rate of varicella-zostor antibody before vaccination
before vaccination
Seropositivity rate of mumps antibody before vaccination
Time Frame: before vaccination
Seropositivity rate of mumps antibody before vaccination
before vaccination
Seropositivity rate of influenza antibody before vaccination
Time Frame: before vaccination
Seropositivity rate of influenza antibody before vaccination
before vaccination
Cross-neutralizing antibody titer of mumps vaccine
Time Frame: 30 days after the vaccination of MV alone or simultaneously with QIV
Cross-neutralizing antibody titer of mumps vaccine against different genotypes of mumps virus
30 days after the vaccination of MV alone or simultaneously with QIV

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 Biotech Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weijun Hu, Master, Shaanxi Provincial Center for Disease Prevention and Control

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.
November 4, 2023

Primary Completion (Estimated)

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.
February 2, 2024

Study Completion (Estimated)

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.
December 1, 2024

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).
November 23, 2023

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.
January 5, 2024

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.
January 17, 2024

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.
January 17, 2024

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.
January 5, 2024

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.
November 1, 2023

More Information

Terms related to this study

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-MUM-MA4001-SN

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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