Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age
Brief Summary: The primary study objectives are:

* To demonstrate that a 2-dose regimen of ProQuad® manufactured with recombinant Human Albumin (rHA) administered at a 3-month interval to healthy children of 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
* To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 9 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1.
* To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well-tolerated compared to children of 12 months of age at the time of Dose 1.

The first primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 11 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.

If the first primary hypothesis was demonstrated, the second primary hypothesis was that a 2-dose regimen of ProQuad® rHA, administered at a 3-month interval to children of 9 months of age, would be non-inferior in terms of antibody response rates to measles, mumps, rubella, and varicella at Day 42 following Dose 2, to the same regimen in children of 12 months of age at the time of Dose 1.

The secondary study objectives are:

* To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
* To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.


Options:
A: Inclusion Criteria:

1. Healthy subject of either gender of 9 months of age
2. Negative clinical history of measles, mumps, rubella, varicella or zoster
3. Informed consent form signed by both parents or legal representative
4. Parent(s) or legal representative able to attend all the scheduled visits with the subject and to understand and comply with the study procedures
5. Both parent or legal representative are over 18 years of age
6. Subject is affiliated to a health social security system

Exclusion Criteria:

1. Febrile illness in the previous 3 days
2. Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
3. Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days
4. Tuberculin test done in the previous 2 days
5. Severe chronic disease
6. Known active tuberculosis
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
8. Hereditary problems of fructose intolerance
9. Prior known sensitivity or allergy to any component of the vaccine
10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
11. Humoral or cellular immunodeficiency,
12. Immunosuppressive therapy \[including systemic corticosteroids (a), given daily or on alternate days at high doses (\>=2 mg/kg/day prednisone equivalent or \>=20 mg/day if the subject's weight was \>10 kg) during at least 14 days in the previous 30 days\]
13. Family history of congenital or hereditary immunodeficiency
14. Receipt of immunoglobulins or blood-derived products in the previous 150 days or scheduled to be administered through Visit 5
15. Receipt of an inactivated vaccine in the previous 14 days
16. Receipt of a live non-study vaccine in the previous 28 days
17. Any medical condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives
18. Current participation or scheduled participation in any other clinical study through Visit 5
B: Inclusion Criteria:

* Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.
* Male or female between 12 and 14 months of age at the time of first vaccination.
* Written informed consent obtained from the parent/guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Concurrently participating 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
* Previous vaccination against measles, mumps, rubella and/or varicella.
* Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
* History of measles, mumps, rubella and/or varicella/zoster diseases.
* Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
* Residence in the same household as the following persons:

  * New-born infants (0-4 weeks of age).
  * Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
  * Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
  * Persons with known immunodeficiency.
* Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
* Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
* Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).
C: 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
D: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
* A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure.
* Free of obvious healthy 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) 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 within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose.
* Previous vaccination against measles, mumps, rubella and/or varicella.
* History of measles, mumps, rubella and/or varicella/zoster diseases.
* Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Rectal temperature ≥38°C or axillary temperature \>=37.5°C at the time of vaccination.
* Residence in the same household as a high risk person e.g.:
* New-born infants (0-4 weeks of age)
* Pregnant women who have a negative history of chickenpox
* Persons with known immunodeficiency

Answer: A