A Phase 2/3 interventional study of Attenuated Mumps vaccine (KMB-17) in phase II and III and Placebo in phase II in Epidemic Parotitis, Mumps, sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences. Active, not recruiting at 1 site in China. Open to participants aged 5 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Institute of Medical Biology, Chinese Academy of Medical Sciences · Phase 2/3, Interventional, and Prevention
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).
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.
83 studies on the registry are indexed under Mumps; 8 are open to participants now.
This study's enrollment of 11,999 is above the median of 897 across 70 interventional studies indexed under Mumps.
Browse Mumps studies →Institute of Medical Biology, Chinese Academy of Medical Sciences is the lead sponsor of 29 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
≥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
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
Biological: Placebo in phase II
≥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
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
Biological: Placebo in phase III
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 360 children (5-11 years old) on 0 day
Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)\[≥4.3 logCCID50/ml\] in 5640 children (5-11 years old) on 0 day
Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
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.
Time frame: 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.
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 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
Time frame: within 12 months after vaccination
Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-14 days after vaccination
Time frame: within 14 days after vaccination
Phase II/III: Adverse reactions/events rate
Occurence of adverse reactions/events within 0-28 days after vaccination
Time frame: within 28 days after vaccination
Phase II/III: Serious adverse events rate
Occurence of serious adverse events within 12 months after vaccination
Time frame: 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
Time frame: 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
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
To compared the the number of cases of mumps in the vaccine group and the placebo group after injection within 12 months after vaccination
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: at 3, 7, 14, 28 days after vaccination
Started Oct 2020 (actual). Primary completion is estimated for Jul 2024, 44 months after the start.
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This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Institute of Medical Biology, Chinese Academy of Medical Sciences