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:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02481232
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants unimmunized Group A\&C meningococcal conjugate vaccine or Group A meningococcal polysaccharide vaccine which is above 2\~11 months-old, and healthy toddler more than 1-year-old without booster immunization.
* The guardian or himself informed consent, and signed the informed consent form;
* The guardian and family agreed to abide by the requirements of clinical trial scheme;
* Participants has no history of immunoglobulin vaccination in the last 2 months / 2 months-old infants has no history of immunoglobulin vaccination after born, there is no history of other live vaccine inoculation before vaccination in 14 days, within 7 days without other inactivated vaccine immunization history;
* the axillary temperature \< 37.1 ℃;
* 2-months-old group in the age of 61-90 days;
* 7-months-old group in the age of 211-300 days;
* 1-year-old group in age of one full year of life.
Exclusion Criteria:
* Have allergies, convulsions, seizures, encephalopathy and psychiatric history or family history;
* Neomycin, streptomycin and polymyxin B allergies;
* With immunodeficiency, immunosuppressant therapy;
* History of meningitis;
* Women in lactation or pregnant;
* Acute febrile diseases and infectious diseases;
* History of labor abnormalities, choking rescue, congenital malformations, developmental disorders or serious chronic disease patients;
* Had a severe allergic reaction of vaccination in the past;
* Took oral steroids more than 14 days in last month;
* Had high fever (axillary temperature≥38.0℃ or higher)in the past three days;
* Prepare to attend or is in any other drug clinical study;
* Meningococcal vaccine contraindications and any situation which researchers think that may affect test evaluation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
55 Years
Study:
NCT02481232
Study Brief:
Protocol Section:
NCT02481232