Sample 62 — Human Eval Diff

Ground Truth

Inclusion Criteria:Aged 6 to < 36 months of age on the day of first study vaccination (study product administration).Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg.Note: This inclusion criterion only applies to subjects 6 to < 12 months of age on the day of the first study visit.Informed consent form has been signed and dated by the parent(s) or guardian(s).Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.Exclusion Criteria:Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine.Previous vaccination against influenza (in the 2016-2017 season) with either the trial vaccine or another vaccine.Receipt of immune globulins, blood, or blood-derived products in the past 3 months.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥ 100.4°F [38.0°C]).

A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.Identified as a natural or adopted child of either the Investigator or an employee with direct involvement in the proposed study.History of serious adverse reactions to any influenza vaccine.Personal history of Guillain-Barré Syndrome.Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

Prediction**Eligibility Criteria for Version 1:**
**Inclusion Criteria:**
- **Age:** 6 to < 36 months of age.
- **Birth Weight:** ≥ 2.5 kg.
- **Informed Consent Form:** Signed and dated by the parent(s) or guardian(s).
- **No Previous Vaccination Against Influenza:** Not previously vaccinated against influenza.
- **Receipt of Vaccine in the 30 Days Before First Trial Vaccination:** Not received any vaccine in the 30 days leading up to the first trial vaccination.
- **Previous Vaccination Against Influenza:** Not previously vaccinated against influenza.
- **History of Serious ARs to any influenza vaccine:** Known or suspected congenital or acquired immunodeficiency.
- **History of Guillain-Barré Syndrome:** Known or suspected.
- **Personal History of Neurological Disorder:** Known or suspected.
- **Known Seropositivity for Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C:** Known or suspected.
- **Serum Glomerular Filtration Rate (SGFR):** Not known or suspected.
- **Thrombocytopenia:** May be a contraindication for intramuscular vaccination.
- **Bleeding Disorder:** Not currently interfering with trial conduct or completion.
- **Chronic Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.
- **Moderate or Severe Acute Illness:** In the opinion of the Investigator, at a stage where it might interfere with trial conduct or completion.