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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01218451
Eligibility Criteria:
Inclusion Criteria:
* Subject is an infant aged 8 to 11 weeks at the time of first vaccination
* Subject is clinically healthy as determined by the investigator's clinical judgment through collection of medical history and physical examination
* Subject was born at full term of pregnancy (\>= 37 weeks) with a birth weight \>= 2 kg
* The parent(s) or legally authorized representative of the subject provides written consent for participation
* The parent(s) or legally authorized representative of the subject has the ability to understand and comply with the requirements of the protocol
* The parent(s) or legally authorized representative and the subject will be available for the duration of the study
* The parent(s) or legally authorized representative of the subject agrees to keep a subject diary
Exclusion Criteria:
* Subject has a history of severe allergic reactions or anaphylaxis, or has a known sensitivity or allergy to any components of the vaccines
* Subject has had an acute or chronic infection requiring systemic therapy (antibiotic or antiviral) or other prescribed treatment within the 2 weeks prior to the first vaccination in this study
* Subject has a rash or dermatologic condition which may interfere with injection site reaction rating
* Subject currently has, or has a history of, any significant cardiovascular, respiratory, hepatic, renal, metabolic, autoimmune, rheumatic, hematological, neurological, or neurodevelopmental disorder
* Subject has a disease, or is currently undergoing a form of treatment, or was undergoing a form of treatment within 30 days prior to study entry, that could be expected to influence immune response
* Subject has received any blood products or immunoglobulins within 60 days of study entry
* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of the scheduled first vaccination
* Subject has previously been vaccinated against meningococcal C disease
* Subject has a known or suspected immune dysfunction
* Subject has a functional or surgical asplenia (e.g. due to a pathologic hemoglobinopathy, leukemia, lymphoma, etc.)
* Subject was administered an investigational drug within six weeks prior to study entry or is concurrently participating in a clinical study that includes the administration of an investigational product
* Subject or his/her parent(s) / legally authorized representative are in a dependent relationship with the study investigator or with a study team member; dependent relationships include close relatives (i.e. children, partner/spouse, siblings) as well as employees of the investigator or site conducting the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Weeks
Maximum Age:
11 Weeks
Study:
NCT01218451
Study Brief:
Protocol Section:
NCT01218451