Please select the eligibility criteria that correspond to the clinical trial below.
Title: Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine Given to Healthy Children in Their Second Year of Life
Brief Summary: This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.


Options:
A: Inclusion Criteria:

* Healthy subject of either gender,
* Age from 12 to 22 months,
* Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
* Informed consent form signed by the parent(s) or by legal representative
* Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

Exclusion Criteria:

* Recent (≤ 3 days) history of febrile illness
* Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
* Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
* Prior known sensitivity/allergy to any component of the vaccine
* Severe chronic disease,
* Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
* Humoral or cellular immunodeficiency,
* Current immunosuppressive therapy
* Family history of congenital or hereditary immunodeficiency
* Hereditary problems of fructose intolerance
* Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
* Known active tuberculosis
* Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
* Receipt of immunoglobulins or blood-derived products in the past 150 days
* Receipt of an inactivated vaccine in the past 14 days
* Receipt of a live vaccine in the past 28 days
* Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
* Participation in another clinical study in the past 30 days
B: Inclusion Criteria:

* 12 to 15 months of age (not reached their 16th month birthday);
* In good health;
* Parent/guardian available by telephone or for home visits;
* Ability of the parent/guardian to understand and comply with the requirements of the protocol;
* Signed informed consent by parent/guardian; and
* Up to date with the primary series of recommended vaccines per standard clinic practice and local vaccine availability.

Exclusion Criteria:

* Previous known measles, mumps, rubella or varicella disease;
* Previous vaccination against measles, mumps, rubella or varicella disease;
* Hypersensitivity to egg or egg protein;
* Signs or symptoms of any immunosuppressive or immune deficiency disease or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
* Acute febrile (\>100.0oF \[37.8°C\] oral) illness or clinically significant upper respiratory illness within the 72 hours prior to enrollment;
* Use of aspirin (acetylsalicylic acid) or aspirin-containing products in the month prior to enrollment, or expected use of aspirin while enrolled in this study;
* Administration of any intranasal medication within two weeks prior to enrollment or expected receipt during this study;
* Administration of any live virus vaccine within one month prior to enrollment through 30 days after Visit 3;
* Administration of any inactivated vaccine within two weeks prior to enrollment through 30 days after Visit 3;
* Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study;
* Receipt of any blood product within three months prior to vaccination or expected receipt within the study duration; and
* Any condition which, in the opinion of the investigator, would interfere with the interpretation or evaluation of the vaccines.
* History of two or more episodes of medically attended wheezing illness by parent/guardian report.
* History of medically attended wheezing illness or bronchodilator medication use within four weeks of enrollment by parent/guardian report.
C: Inclusion Criteria:

* A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion Criteria:

* History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
D: Inclusion Criteria:

* Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
* A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
* Written informed consent obtained from the parents or guardian of the subject,
* Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
* Parents/guardian of the subject must have a telephone or be able to be contacted by telephone

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).
* Previous vaccination against hepatitis A,
* History of hepatitis A,
* Known exposure to hepatitis A,
* Previous vaccination against measles, mumps, rubella and/or varicella,
* History of measles, mumps, rubella and/or varicella,
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,
* Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
* A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
* History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,
* History of anaphylactic or anaphylactoid reactions to egg proteins,
* History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.
* Major congenital defects or serious chronic illness,
* Active untreated tuberculosis,
* History of significant blood dyscrasias
* History of any neurologic disorder (a history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject)
* Acute disease at the time of vaccination
* Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period

Answer: C