MumpsPhase 3NCT02692599
Safety and Immunogenicity Study of Live Attenuated Mumps Vaccines in Healthy Infants
A Phase 3 study testing investigational live attenuated mumps vaccine 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 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. Read more about this study
- Who is it for?
- Ages 8 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Mumps
- What is being tested?
- investigational live attenuated mumps vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to 15 Jul 2016
- Phase
- Phase 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 8 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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;
Who cannot join
- 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) about vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- Receipt of any of the following products:
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- Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
- Any live attenuated vaccine within 28 days prior to study entry;
- Any other investigational medicine(s) within 30 days prior to study entry;
- Blood product (e.g., immunoglobulin) within 3 months prior to study entry;
- 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 (such as 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):
- Receipt of any other investigational or unregistered product (drug or vaccine);
- Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for > 14 days consecutively, except for inhalant or locally administrated corticosteroid;
- Receipt of immunoglobulin and/or blood product;
- Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
Trial locations and contacts
1 site in 1 country.
China1 site
Dingxing County Center for Disease Control and Prevention
Baoding, Hebei, 072650
About this study
Official title: 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.
Read the 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.
- Conditions
- Mumps
- Being tested
- investigational live attenuated mumps vaccine, control live attenuated mumps vaccine
- Keywords
- live attenuated mumps vaccine, safety, immunogenicity, infant
- Medical subject headings
- Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigational live attenuated mumps vaccineBiological
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
control live attenuated mumps vaccineBiological
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | * Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
* Intervention: investigational live attenuated mumps vaccine; Receives: Biological: investigational live attenuated mumps vaccine |
| Control Group | Active comparator | * Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
* Intervention: control live attenuated mumps vaccine; Receives: Biological: control live attenuated mumps vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCRs) of susceptible subjects in each group
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.
Measured: 28 days
Secondary outcomes (5)
The incidences of adverse events (AEs) of each group
AEs occurred within 28 days after injection will be collected.
Measured: 28 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 28 days after injection will be collected.
Measured: 28 days
The post-immune geometric mean titers (GMTs) of susceptible subjects in each group
Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible.
Measured: 28 days
The overall SCRs of each group
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.
Measured: 28 days
The overall post-immune GMTs of each group
The GMTs of all the subjects in each group.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completion15 Jul 2016
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingchen Ma, Principal investigator, Hebei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692599
- Sponsor's protocol ID
- PRO-MUMPS-3001
- Status last verified
- Apr 2016
- First submitted
- 23 Feb 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
- ClinicalTrials.gov ID
- NCT02692599
- Acronym / sponsor ID
- PRO-MUMPS-3001
- Conditions
- Mumps
- Keywords
- live attenuated mumps vaccine, safety, immunogenicity, infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: investigational live attenuated mumps vaccine* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated mumps vaccine; |
| Control Group | Active comparator | Biological: control live attenuated mumps vaccine* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated mumps vaccine; |
Who may qualify
- Ages
- 8 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (22 listed)
- 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) about 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 |
|---|---|---|
| investigational live attenuated mumps vaccineThe investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. | Biological | Experimental Group |
| control live attenuated mumps vaccineThe control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd. | Biological | Control Group |
Primary outcome
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.
5 secondary outcomes
The incidences of adverse events (AEs) of each group
Time frame: 28 days
The incidences of serious adverse events (SAEs) of each group
Time frame: 28 days
The post-immune geometric mean titers (GMTs) of susceptible subjects in each group
Time frame: 28 days
The overall SCRs of each group
Time frame: 28 days
The overall post-immune GMTs of each group
Time frame: 28 days
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 26 Oct 2017.
- 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.
Jingchen Ma principal investigator
Hebei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing investigational live attenuated mumps vaccine 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 4 inclusion and 22 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 26 Oct 2017. 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 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?
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 rates (SCRs) of susceptible subjects in each group (time frame: 28 days). 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 26 Oct 2017.