MumpsPhase 4NCT04364399
Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine
A Phase 4 study testing Mumps vaccine and measles, mumps and rubella combined vaccine, live in people with Mumps, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV). Read more about this study
- Who is it for?
- Ages 8 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Mumps
- What is being tested?
- Mumps vaccine and measles, mumps and rubella combined vaccine, live
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2020to 7 Apr 2021
- Phase
- Phase 4
- 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 8 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy volunteers between 8 - 12 months old;
- Proven legal identity;
- Written consent of the guardian(s) of the volunteer
Who cannot join
- Received mumps vaccine or vaccine containing mumps virus;
- History of mumps;
- Axillary temperature > 37.4 °C;
- History of allergy to any vaccine or vaccine ingredient;
- History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Autoimmune disease or immunodeficiency or immunosuppression;
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- Congenital malformation, genetic defects, severe malnutrition;
- Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
- Severe chronic diseases (e.g., severe cardiovascular disease, liver and kidney disease beyond the control of drugs, or cancer)
- Severe neurological disorders (epilepsy, seizures or convulsions) or psychosis;
- History of thyroidectomy, absence of spleen, functional absence of spleen, and any condition resulting from absence of spleen or splenectomy;
- Receipt of any of the following products:
- Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- Any live attenuated vaccine within 28 days prior to study entry;
- Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
- Blood product within 3 months prior to study entry;
- Any immunosuppressant, cytotoxic medicine, or oral corticosteroids;
- Any of the acute disease or attack of the chronic disease within 7 days;
- Pregnant in cohabitants or congenital immune diseases;
- Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded
Trial locations and contacts
1 site in 1 country.
China1 site
Hezhou Center for Disease Prevention and Control
Hezhou, Guangxi, 542699
About this study
Official title: Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.
The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
Read the detailed description
The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
- Conditions
- Mumps
- Being tested
- Mumps vaccine, measles, mumps and rubella combined vaccine, live
- Keywords
- Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants
- Medical subject headings
- Mumps, Measles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mumps vaccineBiological
One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
measles, mumps and rubella combined vaccine, liveBiological
One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Mumps vaccine, one dose Receives: Biological: Mumps vaccine |
| Control group | Active comparator | measles, mumps and rubella combined vaccine, live, one dose Receives: Biological: measles, mumps and rubella combined vaccine, live |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rate of hemagglutination inhibition (HI) antibody
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
Measured: the 30th day after vaccination
Secondary outcomes (4)
The GMT of HI antibody
Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine
Measured: the 30th day after vaccination
The incidence of the solicited local and systemic adverse reactions
Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination
Measured: from day 0 to day 14 after vaccination
The incidence of the unsolicited adverse events
Safety Index
Measured: from day 0 to day 30 after immunization
The incidence of the serious adverse events
Safety Index
Measured: from day 0 to day 30 after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start18 Nov 2020
- Primary completion18 Nov 2020
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lirong Huang, Bachelor, Principal investigator, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364399
- Sponsor's protocol ID
- PRO-MUMPS-4006
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2020
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of Mumps Vaccine in Healthy Infants Aged 8 ~12 Months.
- ClinicalTrials.gov ID
- NCT04364399
- Acronym / sponsor ID
- PRO-MUMPS-4006
- Conditions
- Mumps
- Keywords
- Mumps, Mumps vaccine, measles, mumps and rubella combined vaccine, live, infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 28 Apr 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.
The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
Detailed description
The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Mumps vaccineMumps vaccine, one dose |
| Control group | Active comparator | Biological: measles, mumps and rubella combined vaccine, livemeasles, mumps and rubella combined vaccine, live, one dose |
Who may qualify
- Ages
- 8 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy volunteers between 8 - 12 months old;
- Proven legal identity;
- Written consent of the guardian(s) of the volunteer
Key exclusion criteria (20 listed)
- Received mumps vaccine or vaccine containing mumps virus;
- History of mumps;
- Axillary temperature > 37.4 °C;
- History of allergy to any vaccine or vaccine ingredient;
- History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
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 |
|---|---|---|
| Mumps vaccineOne dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50 | Biological | Experimental group |
| measles, mumps and rubella combined vaccine, liveOne dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50 | Biological | Control group |
Primary outcome
The seroconversion rate of hemagglutination inhibition (HI) antibody
Time frame: the 30th day after vaccination
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
4 secondary outcomes
The GMT of HI antibody
Time frame: the 30th day after vaccination
The incidence of the solicited local and systemic adverse reactions
Time frame: from day 0 to day 14 after vaccination
The incidence of the unsolicited adverse events
Time frame: from day 0 to day 30 after immunization
The incidence of the serious adverse events
Time frame: from day 0 to day 30 after immunization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Lirong Huang, Bachelor principal investigator
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mumps vaccine and measles, mumps and rubella combined vaccine, live in people with Mumps, run by Sinovac (Dalian) Vaccine Technology Co., Ltd. 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 3 inclusion and 20 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: finished, as of the sponsor's last update on 18 Aug 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The seroconversion rate of hemagglutination inhibition (HI) antibody (time frame: the 30th day after vaccination). 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 18 Aug 2021.