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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00885105
Eligibility Criteria:
Inclusion Criteria:
* Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
* Available for the duration of the study.
* Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
* Parent/legal acceptable representative willing and able to provide informed consent.
* Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
* Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
* Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.
Exclusion Criteria:
* Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
* Previous history of influenza vaccination (Group 2 subjects only).
* Receipt of any vaccine in the 14 days prior to enrollment.
* An acute illness with or without fever (rectal temperature ≥ 38.0 °C \[or ≥100.4 °F\]) in the 72 hours preceding enrollment in the trial.
* Known bleeding disorder.
* Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional 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 human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
* Known HIV, hepatitis B, or hepatitis C infection.
* Receipt of blood or blood-derived products within 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:
6 Months
Maximum Age:
11 Months
Study:
NCT00885105
Study Brief:
Protocol Section:
NCT00885105