Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of M-M-R™II Manufactured With Recombinant Human Albumin (rHA) and VARIVAX® When Administered Concomitantly by Intramuscular (IM) Route or Subcutaneous (SC) Route at Two Separate Injection Sites in Healthy Subjects 12 to 18 Months of Age
Brief Summary: Primary objective:

To compare if, when given concomitantly with VARIVAX® by the same route at 12-18 months of age using separate injection sites, a single dose of M-M-RTMII administered by IM route is as immunogenic as a single dose of M-M-RTMII administered by SC route in terms of response rates to measles, mumps and rubella at 42 days following the vaccination.

AND/OR

To compare if, when given concomitantly with M-M-RTMII by the same route at 12-18 months of age using separate injection sites, a single dose of VARIVAX® administered by IM route is as immunogenic as a single dose of VARIVAX® administered by SC route in terms of response rate to varicella at 42 days following the vaccination

Secondary objectives:

* To summarise the antibody titres to measles, mumps, rubella and varicella at 42 days following the vaccination in children immunised with M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC,
* To evaluate the safety profiles of M-M-R™II and VARIVAX® administered concomitantly at two separate injection sites by the same route IM or SC.


Options:
A: Inclusion Criteria:

* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol
* A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after 36 weeks gestation.
* Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
* Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® \[palivizumab, MedImmune\], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
* Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
* History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at time of enrollment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply:

* History of measles, mumps, rubella or varicella.
* Previous vaccination against measles, mumps, rubella or varicella.
* Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
* Patients receiving immunosuppressive therapy.
* Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
* Individuals with primary and acquired immunodeficiency states.
* Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* Individuals with active tuberculosis.
* Acute disease at time of booster vaccination.
B: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
* Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
* Written informed consent obtained from the subject;
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
* Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
* Previous vaccination against HZ, except the study vaccine administered in the primary study;
* History of HZ (shingles);
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.
C: Inclusion Criteria:

* Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
* Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
* Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria:

* Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
D: Inclusion Criteria:

1. Healthy subject of either gender,
2. Age 12 to 18 months ,
3. Consent form signed by both parent(s) or by the legal representative properly informed about the study,
4. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

1. Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
2. Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
3. Any recent (≤30 days) exposure to measles, mumps or rubella,
4. Any recent (≤30 days) exposure to varicella or zoster involving:
5. Any recent (≤3 days) history of febrile illness
6. Any severe chronic disease,
7. Active untreated tuberculosis,
8. Known personal history of seizures,
9. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
10. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed
12. Any recent tuberculin test (≤7 days) or scheduled tuberculin test through visit 2,
13. Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 2,
14. Any recent receipt of an inactivated or a live vaccine (≤30 days) or scheduled vaccination through visit 2

Answer: D