Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety and Immunogenicity of Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
Brief Summary: This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.


Options:
A: 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.
B: 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.
C: 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.
D: 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

Answer: A