Epidemic Parotitis, MumpsPhase 2/3NCT04591405
Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
A Phase 2/3 study testing Attenuated Mumps vaccine (KMB-17) in phase II and III and Attenuated Mumps vaccine (KMB-17) in phase III in people with Epidemic Parotitis, Mumps, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Epidemic Parotitis, Mumps
- What is being tested?
- Attenuated Mumps vaccine (KMB-17) in phase II and III and Attenuated Mumps vaccine (KMB-17) in phase III
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,999 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2020to 1 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 ℃.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430079
About this study
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).
Read the 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.
- Conditions
- Epidemic Parotitis, Mumps
- Being tested
- Attenuated Mumps vaccine (KMB-17) in phase II and III, Placebo in phase II, Attenuated Mumps vaccine (KMB-17) in phase III, Placebo in phase III
- Keywords
- Mumps, F-genotype, Live Attenuated Vaccine, Human Diploid Cell
- Medical subject headings
- Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attenuated Mumps vaccine (KMB-17) in phase II and IIIBiological
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
Placebo in phase IIBiological
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Attenuated Mumps vaccine (KMB-17) in phase IIIBiological
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
Placebo in phase IIIBiological
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
| Study group | Role | What they receive |
|---|---|---|
| Attenuated Mumps vaccine (KMB-17) in phase II and III | Experimental | ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day Receives: Biological: Attenuated Mumps vaccine (KMB-17) in phase II and III |
| Placebo in phase II | Placebo comparator | Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day Receives: Biological: Placebo in phase II |
| Attenuated Mumps vaccine (KMB-17) in phase III | Experimental | ≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day Receives: Biological: Attenuated Mumps vaccine (KMB-17) in phase III |
| Placebo in phase III | Placebo comparator | Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day Receives: Biological: Placebo in phase III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Measured: 28 day after the vaccination
Phase II: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Measured: 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
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
Measured: within 12 months after vaccination
Secondary outcomes (11)
Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-14 days after vaccination
Measured: within 14 days after vaccination
Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-28 days after vaccination
Measured: within 28 days after vaccination
Phase II/III: Serious adverse events rate
Occurence of serious adverse events within 12 months after vaccination
Measured: within 12 months after vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Measured: 28 day after the vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 28 days after the vaccination
Measured: 28 day after the vaccination
Phase III: The protective effect of the MuV vaccine group compared with the placebo group in preventing mumps
To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination
Measured: within 12 months after vaccination
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
To compared the positive conversion rate of MuV hemagglutination inhibition antibody at 28 days after vaccination.
Measured: 28 day after the vaccination
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
To compared the positive conversion rate of Muv hemagglutination inhibition antibody at 28 days after vaccination.
Measured: 28 day after the vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
To compared positive rate of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Measured: 12 months after vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
To compared the GMT of the hemagglutination inhibition antibody and neutralizing antibodies against MuV at 12 months after the vaccination
Measured: 12 months after vaccination
Phase II/III: Detoxification
Viral copies in pharyngeal swabs or gargles at 3, 7, 14, 28 days after vaccination were tested by PCR.
Measured: at 3, 7, 14, 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start12 Oct 2020
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemic Parotitis, MumpsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Qihan Li, Study chair, Institute of Medical Biology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591405
- Sponsor's protocol ID
- 20190710
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2020
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
- ClinicalTrials.gov ID
- NCT04591405
- Acronym / sponsor ID
- 20190710
- Conditions
- Epidemic Parotitis, Mumps
- Keywords
- Mumps, F-genotype, Live Attenuated Vaccine, Human Diploid Cell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11,999 participants (actual)
- Lead sponsor
- Institute of Medical Biology, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, double-blind, placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| Attenuated Mumps vaccine (KMB-17) in phase II and III | Experimental | 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 in phase II | Placebo comparator | Biological: Placebo in phase IIFreeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day |
| Attenuated Mumps vaccine (KMB-17) in phase III | Experimental | 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 in phase III | Placebo comparator | Biological: Placebo in phase IIIFreeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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 ℃.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| Placebo in phase IIFreeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day | Biological | Placebo in phase II |
| 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 |
| Placebo in phase IIIFreeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day | Biological | Placebo in phase III |
Primary outcome
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.
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.
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
11 secondary outcomes
Phase II/III: Adverse reactions/events rate
Time frame: within 14 days after vaccination
Phase II/III: Adverse reactions/events rate
Time frame: within 28 days after vaccination
Phase II/III: Serious adverse events rate
Time frame: 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
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time frame: 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
Phase III: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine
Time frame: 28 day after the vaccination
Phase III: Positive conversion rate of MuV neutralization antibody of MuV Vaccine
Time frame: 28 day after the vaccination
Phase II/III: Positive rate of the hemagglutination inhibition antibody and neutralizing antibody
Time frame: 12 months after vaccination
Phase II/III: The GMT of the hemagglutination inhibition antibody and neutralizing antibody
Time frame: 12 months after vaccination
Phase II/III: Detoxification
Time frame: at 3, 7, 14, 28 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qihan Li study chair
Institute of Medical Biology, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Attenuated Mumps vaccine (KMB-17) in phase II and III and Attenuated Mumps vaccine (KMB-17) in phase III in people with Epidemic Parotitis, Mumps, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II: Positive conversion rate of MuV hemagglutination inhibition antibody of Muv Vaccine (time frame: 28 day after the vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.