Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese In… (NCT03133923) | Clinical Trial Compass
UnknownPhase 2
Phase II of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants
China1,080 participantsStarted 2017-05-20
Plain-language 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. 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 preliminary test results showed that the vaccine possessed good immunogenicity and good antigenic cross-reactivity. The application of this vaccine will provide more effective means to prevent and control of mumps epidemic.
Who can participate
Age range
8 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy males and females (from 8 months to 24 months old) as determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator.
* Provided legal identification for the sake of recruitment.
* Without the routine corticosteroids of vaccination .
* Never has gone down with mumps or taken a vaccine contain mumps.
* parent(s)/legal guardian(s) are able to understand and sign informed consents and be able to read a thermometer and dividing ruler .At the same time,the parent(s)/legal guardian(s)should have the ability and objective to comply with the requirements of the protocol.
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; can persist for a 1-month visit and receive blood sample and throat swab collection according to program requirements.
* Axillary temperature ≤37℃.
Exclusion Criteria:
* Subject who has a medical history of Mumps or taken a vaccine contain mumps.
* Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Convulsant,encephalopathy,psychosis or family histoty of epileptics.
* Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will couse the contraindication of subcutaneous injection
* Any prior administration of attenuated live va…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive conversion rate of Muv hemagglutination inhibition antibody of different single dose of Muv Vaccine
Timeframe: the 0 days（before vaccination） and 28 day after the vaccination
2
Positive conversion rate of Muv neutralization antibody of different single dose of Muv Vaccine
Timeframe: the 0 days（before vaccination） and 28 day after the vaccination
Trial details
NCT IDNCT03133923
SponsorInstitute of Medical Biology, Chinese Academy of Medical Sciences