Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.
Brief Summary: The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.


Options:
A: Inclusion Criteria:

* Age 6-59 months of age (not yet reached their 5th birthday)
* Parent or guardian available by telephone
* Available for illness visits at clinic or at home during the influenza surveillance period
* Written informed consent (and Health Insurance Portability and Accountability Act \[HIPAA\] authorization for U.S. Participants) obtained from the participant's parent or legal guardian and
* Ability of the parent/guardian to understand and comply with the requirements of the protocol

Exclusion Criteria:

* History of hypersensitivity to any component of CAIV-T or inactivated influenza vaccine, including egg or egg protein
* History of hypersensitivity to gentamicin
* Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy
* History of Guillain-Barre syndrome
* Medically-diagnosed wheezing, bronchodilator use, or steroid use (systemic or inhaled) within the previous 42 days by parent report or chart review (e.g., children with recent persistent asthma are excluded), or history of severe asthma
* Acute febrile (\>100.0 degrees F or \>37.8 degrees C oral or equivalent) illness or acute respiratory illness, including sore throat, within three days prior to enrollment
* Receipt of an investigational product within 30 days prior to enrollment or expected receipt during this study
* Use of aspirin or salicylate-containing products 30 days prior to enrollment or expected receipt during this study
* Use of anti-influenza medications (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment or expected receipt during this study
* Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study
* Administration of any live virus vaccine within 30 days prior to enrollment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination
* Administration of any inactivated vaccine within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days prior to enrollment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination
* Close contact who is severely immunocompromised (e.g., transplant recipient)
* Family member or household contact who is an employee of the research center or otherwise involved with the conduct of the study and
* Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
B: Group A:

Inclusion criteria:

* healthy children and adolescents aged 36 months to 15 years who will be immunized as part of the intervention.

Exclusion criteria:

1. anaphylactic reaction to a previous dose of LAIV or TIV
2. known IgE-mediated hypersensitivity to eggs manifested as hives, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock
3. history of asthma
4. medically diagnosed or treated wheezing within 42 days before enrollment
5. Guillain-Barré syndrome within eight weeks of a previous influenza vaccine
6. anaphylactic reaction to gentamicin
7. anaphylactic reaction to gelatin
8. anaphylactic reaction to neomycin
9. anaphylactic reaction to arginine
10. pregnancy
11. household contact who is severely immunocompromised being cared for in a protective environment (i.e hematopoietic stem cell transplant)
12. use of aspirin or salicylate-containing products within 30 days before enrollment.

Group B:

Inclusion Criteria

* other Hutterite community members that are not in Group A

Exclusion Criteria:

* there are no exclusion criteria for this category of participants
C: Inclusion Criteria:

* Healthy male or non-pregnant female participants aged ≥ 6 calendar months to \< 18 years at the time of the first study vaccination.
* For participants aged ≥ 6 months to \< 9 years, born after a normal gestation period (between 36 and 42 weeks).
* Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

* Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
D: Inclusion Criteria:

* A male or female child \>= 6 months and \< 18 years of age at the time of first vaccination.
* Written informed consent obtained from the subject's parent/guardian.
* Documentation of assent for children 9 to \< 18 years of age (or as deemed mandatory by local practice).
* Satisfactory baseline medical assessment by history and physical examination
* Parent/guardian and subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
* Parents/guardians and subjects who the investigator believes understand the requirements of the protocol and can and will comply with them.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential must

  * have practiced adequate contraception for 30 days prior to vaccination, and
  * have a negative pregnancy test on the day of each vaccination, and
  * have agreed to continue adequate contraception for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Medical history of physician-confirmed infection with an H5N1 virus.
* Previous vaccination at any time with an H5N1 vaccine.
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
* Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
* Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject or parent/guardian unable/unlikely to provide accurate safety reports.
* Evidence of current subject or parent/guardian substance abuse, including alcohol, by medical history.
* Presence of a temperature \>= 38.0ºC by any method, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Receipt of systemic glucocorticoids within 1 month prior to first dose of test article or any other cytotoxic or immunosuppressive drug within 6 months prior to first dose of test article. Receipt of any immunoglobulins and/or any blood products within 3 months of first test article administration or planned administration of any of these products during the study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
* Administration of an inactivated seasonal influenza vaccine within 14 days, or of a live, attenuated seasonal influenza vaccine within 30 days before the first test article dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first test article dose.
* Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the "Day 42" visit.
* Any known or suspected allergy to any constituent of influenza vaccines or history of severe reaction to any previous influenza vaccination.
* Known pregnancy, or a positive urine pregnancy test result prior to each test article dose.
* Lactating or nursing.
* Child in care.

Answer: C