Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT04591405
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT04591405
Study Brief:
Protocol Section:
NCT04591405