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 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT00808392
Eligibility Criteria:
Inclusion Criteria:
* Infants of either sex, aged 2 - 4 months
* In good health as determined by:
* medical history
* physical examination
* clinical judgment of the investigator;
* Available for all visits scheduled in the study and able to comply with all study regulations
* For whom written informed consent has been obtained from at least one parent or legal guardian
Exclusion Criteria:
* Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
* Infants who have received any other Haemophilus influenzae type b immunization dose before
* Infants who presented a previous disease potentially related to Haemophilus influenzae type b
* Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
* Premature (before 37th week of gestation) or birth weight less than 2500 g
* History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
* Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
* Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
* Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
* Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
* Subjects with a clinically significant genetic anomaly
* Treatment with corticosteroids or other immunosuppressive drugs
* Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
* Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
* Participation in any other investigational trial simultaneously
* Planned surgery during the study period
* Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
4 Months
Study:
NCT00808392
Study Brief:
Protocol Section:
NCT00808392