Safety and Efficacy of ProQuad® in Children 6-24 Month Being Evaluated for Solid Organ Transplant

Primary Aim:

To measure the antibody response to ProQuad® vaccination given earlier than the current
recommended age in patients from the age of 6 months to 24 months who are being considered
and/or evaluated for any solid organ transplant (heart, liver or kidney) within the next five
years. These subjects would not reach the recommended ages to receive the vaccine before the
transplant.

Hypothesis:

The Investigator proposes the hypothesis that the proposed study population will mount a
clinically significant response to two (2) doses of the ProQuad® vaccine.

Primary Endpoint:

With respect to expected outcomes, the work proposed is expected to provide tools for
optimizing the ProQuad® vaccination strategy in this population.

Secondary Aim:

To determine the safety of ProQuad® vaccination in children aged 6 months to 24 months who
are being considered and/or evaluated for any solid organ transplant (heart, liver, kidney).

Hypothesis :

The Investigator proposes the hypothesis that the study population will have similar safety
profiles compared to children who receive the vaccine at the recommended ages.

Secondary Endpoint:

The secondary outcome measure is represented by the children in the study having either no
adverse effects or minimal adverse effects from the ProQuad® vaccine. Adverse effects will be
monitored via Electronic Medical Records (EMR) for Emergency Department (ED), hospital or
clinic visits, follow-up phone calls to the family/subjects, as well as the vaccination
report card that the parents/legal guardians of the participants in the study will complete
for their child for 7 days after he/she receives each dose of the vaccine.

Inclusion Criteria:

1. Parent and/or legal guardian willing and able to give informed consent.

2. Patients 6 months to 24 months of age who are being considered and/or evaluated for
any solid organ transplant within the next five (5) years who are willing:

- to receive two doses of ProQuad® at least 30 days but no more than 365 days
apart.

- to participate in the three (3) antibody titer blood draws.

Exclusion Criteria:

1. History of allergy to any vaccine component, bleeding disorder, exposure to measles,
mumps, rubella, varicella, or zoster in the 30 days prior to vaccination.

2. Receipt of any blood product or immunoglobulin received in the previous 180 days prior
to vaccination.

3. Previously received any measles, mumps, rubella and/or varicella vaccine either alone
or in combination prior to vaccination.

4. Any condition which causes the investigator to determine that the subject is not
appropriate to enroll.