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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT00858468
Eligibility Criteria:
Inclusion Criteria :
* Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.
* Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.
* Considered to be in good health on the basis of reported medical history and history-directed physical examination.
* Available for the duration of the study.
* Parent/guardian willing and able to provide informed consent.
* Parent/guardian able to attend all scheduled visits and comply with all trial procedures.
* Willingness to permit venipuncture or heel stick for purposes of collecting a blood sample.
Exclusion Criteria :
* Reported allergy to egg proteins, chicken proteins or any other constituent of the vaccine.
* Previous history of influenza vaccination or documented history of influenza infection.
* Receipt of any vaccine in the 7 days prior to enrollment.
* An acute illness with fever (rectal temperature ≥ 38.0 °C \[or ≥ 100.4 °F\]) in the 72 hours preceding enrollment in the trial (defer enrollment).
* Known bleeding disorder.
* Participation in any other clinical trial within 30 days prior to enrollment, or planned participation in another clinical trial prior to termination of the subject's participation in this study.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
* Known HIV-positive or HBsAg-positive mother.
* Known HIV, hepatitis B (HBsAg), or hepatitis C infection.
* Blood or blood-derived products received in the past 2 months.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
9 Months
Study:
NCT00858468
Study Brief:
Protocol Section:
NCT00858468