Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine
Brief Summary: An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: Inclusion Criteria:

* Healthy 2-month-old infants.
* Available for the entire study period.

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study.
* Known contraindication to vaccination.
B: Inclusion criteria:

* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study.
* Male or female subject between 12 and 22 months of age at the time of the first vaccination.
* Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
* Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
* Subjects whose parents/guardians have direct access to telephone/mobile phone.
* Subjects:

  1. with at least one sibling (with negative history of varicella disease/vaccination) at home, or
  2. attending day care center, or
  3. attending childminders, i.e. someone taking care of several children, or
  4. who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.

Exclusion criteria:

* Previous vaccination against measles, mumps, rubella and/or varicella.
* History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.
* Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical.
* Family history of congenital or hereditary immunodeficiency.
* History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
* Major congenital defects or serious chronic illness.
* Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella.
* History of any neurologic disorders or seizures.
* Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.

Additional exclusion criteria for subjects included in the subset:

- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
C: 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
D: 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.

Answer: B