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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01580033
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects aged 3 to 5 months, normal intelligence.
* The subjects' guardians are able to understand and sign the informed consent.
* Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
* Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
* Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
* Subjects with temperature\<=37°C on axillary setting.
Exclusion Criteria for the first vaccination:
* Subject who has a medical history of Meningitis;
* Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
* Subject who is allergic with tetanus toxoid components;
* Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
* Subject who has a history of allergic reactions;
* Any known immunological dysfunction;
* Had received gamma globulin or immune globulin, in the past two weeks
* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
* Any acute infections in last 7 days
* Any prior administration of immunodepressant or corticosteroids in last 6month
* Any prior administration of other research medicines in last 1 month
* Any prior administration of attenuated live vaccine in last 28 days
* Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
* Subject suffering from congenital malformations, developmental delay or serious chronic disease;
* Any acute infections
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Exclusion Criteria for the second or third vaccination:
* Had any Grade 3 or Grade 4 adverse reactions or events associated with investigational vaccine occurred since the vaccination
* Any situation meets the exclusion criteria for first dose;
* Any condition the investigator believed may affect the evaluation of the vaccine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
5 Months
Study:
NCT01580033
Study Brief:
Protocol Section:
NCT01580033