Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11

October 8, 2023 updated by: Institute of Medical Biology, Chinese Academy of Medical Sciences
Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland suppurative swelling and pain with fever. The pathological changes and harm caused by mumps was not only confined to the parotid gland, on the contrary, the social harm caused by serious complications cannot be ignored. As mumps is a vaccine-preventable infectious disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13 genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain of MuV in China was the F genotype. The commonly used vaccine strains represented only a small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A strain, which was the first separation and preparation of the attenuated mumps viruses in China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much safer to use. The results of phase I and II clinical trials showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity in infants (8-24 months old).

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 will recruit 12,000 subjects and be divided into two stages. The first stage will evaluate the immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 720 healthy children aged 5-11 years, and explore the detoxification in 144 subjects, who randomly selected from these 720 subjects. The second stage will evaluate the clinical protective efficacy, immunogenicity and safety of F-genotype mumps live attenuated vaccine (human diploid cells) after vaccination in 11280 healthy children aged 5-11 years.

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.
11999

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 2
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Provincial 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

5 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy people aged 5-11 years (including boundary values), both men and women.
  • Proven legal identity.
  • Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required.
  • Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial.
  • Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

  • Contraindications for vaccination.
  • History of allergy to vaccines or drugs
  • Have a history of mumps disease
  • Except for one dose of vaccine containing mumps at the age of 18~24 months before enrollment, any vaccine containing mumps has been vaccinated.
  • Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days
  • Convulsant,encephalopathy,psychosis or family history of epileptics.
  • Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
  • For any reason, the spleen was removed partially or completely
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection
  • Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases)
  • Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any prior administration of immunodepressant, cytotoxic drugs or corticosteroids in last 6 months(except the corticosteroids spray can treat irritability rhinitis or corticosteroids to cure noncomplication acute dermatitis ).
  • Receipt of immunosuppressive therapy within 6 months before signing the informed consent form, such as long-term systemic glucocorticoid therapy (with systemic glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or similar drugs) ), but local administration (such as ointment, eye drops, inhalation, or nasal spray) is allowed. The local administration should not exceed the dosage recommended in the instructions or have any signs of systemic exposure.
  • Any prior administration of other research medicines during the same period.
  • Any other situations judged by investigators as not suitable for participating in this study

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: Quadruple

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: Attenuated Mumps vaccine (KMB-17) in phase II and III
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Biological: Attenuated Mumps vaccine (KMB-17) in phase II and III
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Placebo Comparator: Placebo in phase II
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Biological: Placebo in phase II
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Experimental: Attenuated Mumps vaccine (KMB-17) in phase III
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Biological: Attenuated Mumps vaccine (KMB-17) in phase III
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Placebo Comparator: Placebo in phase III
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
Biological: Placebo in phase III
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day

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
Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
Time Frame: 28 day after the vaccination
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
28 day after the vaccination
Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
Time Frame: 28 day after the vaccination
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
28 day after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps according with the protocol
Time Frame: within 12 months after vaccination
To compared the the number of cases of mumps in the vaccine group and the placebo group after 29-day-post injection within 12 months after vaccination
within 12 months after vaccination

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
Phase II/III: Adverse reactions/events rate
Time Frame: within 14 days after vaccination
Occurence of adverse reactions/events within 0-14 days after vaccination
within 14 days after vaccination
Phase II/III: Adverse reactions/events rate
Time Frame: within 28 days after vaccination
Occurence of adverse reactions/events within 0-28 days after vaccination
within 28 days after vaccination
Phase II/III: Serious adverse events rate
Time Frame: within 12 months after vaccination
Occurence of serious adverse events within 12 months after vaccination
within 12 months after vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
Time Frame: 28 day after the vaccination
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
28 day after the vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time Frame: 28 day after the vaccination
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
28 day after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps
Time Frame: within 12 months after vaccination
To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination
within 12 months after vaccination
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
Time Frame: 28 day after the vaccination
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
28 day after the vaccination
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
Time Frame: 28 day after the vaccination
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
28 day after the vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
Time Frame: 12 months after vaccination
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
12 months after vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time Frame: 12 months after vaccination
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
12 months after vaccination
Phase II/III: Detoxification
Time Frame: at 3, 7, 14, 28 days after vaccination
Viral copies in pharyngeal swabs or gargles at 3, 7, 14, 28 days after vaccination were tested by PCR.
at 3, 7, 14, 28 days after vaccination

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.
Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hubei Provincial Center for Disease Control and Prevention

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.
  • Study Chair: Qihan Li, Institute of Medical Biology, Chinese Academy of Medical Sciences

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.
October 12, 2020

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.
July 1, 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.
July 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).
September 27, 2020

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.
October 12, 2020

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 19, 2020

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 11, 2023

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.
October 8, 2023

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.
October 1, 2023

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.
  • 20190710

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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