Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of One Dose and Two Doses of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) Compared With Placebo in Healthy Children
Brief Summary: The purpose of this study is to determine the efficacy of the liquid formulation of CAIV-T against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months.


Options:
A: Inclusion Criteria:

* Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to \<72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009) b) aged 6 to \<36 months (Part III of the study; influenza season 2009/2010)
* In good health as determined by: a) medical history, b) physical examination, c) clinical judgment of the investigator

Exclusion criteria:

* Administration of licensed vaccines (including H1N1sw vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol could be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded.
* Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study.
* Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator's judgment.
* Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start.
* Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature equal to or greater than 38.3°C) within the 2 days before enrollment.
* Any serious disease in the opinion of the investigator including, for example: a) cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e) acute or progressive hepatic disease, f) acute or progressive renal disease.
* Known or suspected impairment/alteration of immune function, for example, resulting from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d) high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease).
* Bleeding diathesis.
* History of hypersensitivity to any component of the study medication or chemically related substances.
* History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component.
* Laboratory confirmed influenza disease.
* History of neurological disorder or seizures (febrile seizures allowed).
* Received any influenza vaccine.
* Major surgery planned during the study period.
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study.
B: Inclusion Criteria: (First Season)

* who is aged at least 6 months and less than 36 months of age at the time of enrollment;
* who is in good health as determined by medical history, physical examination and clinical judgement;
* whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained;
* who, along with their parent(s)/legal guardian(s), will be available until the completion of the first season's surveillance phase;
* whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].

(Second Season)

* who was enrolled into the first season of the trial and received at least one vaccination in the primary series;
* who completed the safety and efficacy evaluations during the first season surveillance phase;
* who is in good health as determined by medical history, physical examination and clinical judgement;
* whose parent(s)/legal guardian(s) have provided written informed consent for the second season of the trial after the nature of the study has been explained;
* who, along with their parent(s)/legal guardian(s), will be available until the completion of the second season's surveillance phase;
* whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].

Exclusion Criteria: (First Season)

* whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational);
* who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational);
* with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine;
* with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
* who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.

(Second Season)

* whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
* with Down's syndrome or other known cytogenetic disorders;
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroid of a dose equivalent to 2 mg/kg/day or greater of prednisolone or equivalent to a total of 20 mg/day or greater for children who weigh more than 10 kg, for more than 14 days duration until 2 weeks after corticosteroids have been discontinued;
* who received any blood products, including immunoglobulin, in the period from six months prior to the second season vaccination through to the conclusion of the study;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to the second season vaccination through to the conclusion of the study;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) with the exception of the primary series of study vaccine (CAIV-T/placebo);
* who, in the two weeks prior to receiving the second season vaccination, received a dose of any influenza treatment (commercial or investigational);
* with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine (CAIV-T/placebo);
* with a clinically confirmed respiratory illness with wheezing within two weeks prior to receiving the second season vaccination;
* who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to receiving the second season vaccination or for which use is anticipated during the study;
* who were administered any live virus vaccine within one month prior to receiving the second season vaccination or expected to receive another live virus vaccine within one month of receiving the second season vaccination;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
C: 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
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: B