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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02919293
Eligibility Criteria:
Inclusion Criteria:
* Health infants aged 2 to 5 months.
* Legal guardian has signed written informed consent.
* Guardian may finish the whole visit in the judgment of investigator.
* 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
* Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Exclusion Criteria:
* Fever, body temperature ≥37.1℃.
* History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
* Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
* Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
* Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
* Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
* Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
* Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
5 Months
Study:
NCT02919293
Study Brief:
Protocol Section:
NCT02919293