Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine
Brief Summary: As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.


Options:
A: Inclusion Criteria:

* Adults 60 years of age and older.
* History of Chickenpox.
* Have given written informed consent prior to enrollment.
* History of varicella or long-term (greater than or equal to 30 years) residence in the continental USA.

Exclusion Criteria:

* No history of shingles, no current history of immune suppression (e.g. malignancy or neoplastic disease, corticosteroid therapy).
* No immunosuppression resulting from disease (e.g., malignancy; HIV infection), corticosteroids (except intermittent topical or inhaled corticosteroid \[greater than 800 mcg/day beclomethasone dipropionate or equivalent\]), or other immunosuppressive/cytotoxic therapy (cancer chemotherapy or organ transplantation).
* No active neoplastic disease (except local skin cancer or other malignancies \[e.g., prostate cancer\] that are stable in the absence of immunosuppressive/cytotoxic therapy).
* No prior Herpes Zoster.
* No prior receipt of varicella vaccine.
* No allergic sensitivity to neomycin.
* No history of anaphylactoid reaction to gelatin.
* No significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 5 years).
* Not ambulatory (must not be bed-ridden or homebound).
* No receipt of immune globulin or any other blood product within 3 months before or planned during the 3-5 year study period.
* No receipt of any other immunizations within one month before study vaccination (2 weeks in the case of inactivated influenza vaccines or other non-replicating immunization products \[e.g., dT, pneumococcal vaccine, hepatitis A vaccine, hepatitis B vaccine\]), or scheduled within 6 weeks after study vaccination.
* Not currently receiving antiviral therapy.
* No other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study.
* No intercurrent illness (e.g., urinary tract infection, influenza) that might interfere with the interpretation of the study.
* No females who are pre-menopausal.
* No subjects unlikely to adhere to protocol follow-up.
* No subjects involved in a conflicting (vaccine or investigational drug) clinical trial.
B: Inclusion Criteria:

* Children must be healthy to participate

Exclusion Criteria:

* Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
* Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study.
* They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
* Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination.
* Children must not have been vaccinated against varicella.
* They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start.
* New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
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-month-old males and females with no active liver disease
* A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

Exclusion Criteria:

* Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
* Any immune deficiency
* History of allergy to any of the vaccine components
* History of any seizure disorder

Answer: B