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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
11,999
≥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
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
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
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