Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
Phase II/III of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Healthy Children Aged 5-11
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.
Inclusion Criteria:

 -  Healthy people aged 5-11 years (including boundary values), both men and women.

 -  Proven legal identity.

 -  Participants and parent(s)/legal guardian(s) should understand the contents of the
 informed consent form, the vaccine in this trial, voluntarily sign the informed
 consent form, and be capable of using thermometers, scales, and filling in diary cards
 and contact cards as required.

 -  Participants and parent(s)/legal guardian(s) should be able to communicate well with
 investigators, understand and comply with the requirements of this trial.

 -  Axillary temperature ≤37.0 ℃.

 Exclusion Criteria:

 -  Contraindications for vaccination.

 -  History of allergy to vaccines or drugs

 -  Have a history of mumps disease

 -  Except for one dose of vaccine containing mumps at the age of 18~24 months before
 enrollment, any vaccine containing mumps has been vaccinated.

 -  Any prior administration of attenuated live vaccine in last 15 days;Any prior
 administration of subunit or inactivated vaccines in last 7 days

 -  Convulsant,encephalopathy,psychosis or family history of epileptics.

 -  Those who developed acute disease within 2 weeks, or had symptoms of fever or upper
 respiratory tract infection within 7 days.

 -  For any reason, the spleen was removed partially or completely

 -  Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation
 disorders, platelet abnormalities), significant bruising or blood clotting disorder,it
 will cause the contraindication of subcutaneous injection

 -  Suffering from congenital deformity or serious chronic disease(congenital heart
 disease，Down's syndrome,diabetes,sickle cell anemia,nervous
 illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin
 diseases)

 -  Any prior administration of blood products(immunoglobulin etc.) in last 1 month;Any
 prior administration of immunodepressant, cytotoxic drugs or corticosteroids in last 6
 months(except the corticosteroids spray can treat irritability rhinitis or
 corticosteroids to cure noncomplication acute dermatitis ).

 -  Receipt of immunosuppressive therapy within 6 months before signing the informed
 consent form, such as long-term systemic glucocorticoid therapy (with systemic
 glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone or
 similar drugs) ), but local administration (such as ointment, eye drops, inhalation,
 or nasal spray) is allowed. The local administration should not exceed the dosage
 recommended in the instructions or have any signs of systemic exposure.

 -  Any prior administration of other research medicines during the same period.

 -  Any other situations judged by investigators as not suitable for participating in this
 study