Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix,
Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month
1(Group 2).

All subjects in both groups to provide blood samples prior to vaccination on day 0 and at
month 1 (for Group 2, blood sampling is prior to vaccination with Varivax).

Duration of the study will be approximately 6 months for each subject with a safety telephone
contact 6 months after vaccinations.

Inclusion Criteria:

- Subjects for whom the investigator believes that their parents/ guardians can and will
comply with the requirements of the protocol.

- A male or female child between 4 and 6 years of age, inclusive.

- 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.

- Having received 4 doses of (Diphtheria, Tetanus Acellular Pertussis) DTaP vaccine
using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix
and/or (inactivated poliovirus vaccine, Aventis Pasteur) IPOL in the first 2 years of
life.

- Previously received 1 dose of M-M-RII and Varivax (separate or combined) in the second
year of life.

Exclusion Criteria:

- Use of any investigational or non-registered drug or vaccine other than the study
vaccines within 30 days preceding the administration of study vaccines, 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
non-investigational product or device.

- History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles,
mumps, rubella or varicella disease, or of vaccination against these diseases given
after the second year of life.

- Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.

- Poliovirus vaccination with one or more doses of (oral polio virus) OPV vaccine.

- Administration or planned administration of a vaccine not foreseen by the study
protocol within 30 days of study vaccination and ending at Day 30.

- Chronic administration or planned administration of immunosuppressants or other immune
modifying drugs within six months prior to study vaccination or planned administration
during the study period ending at Day 30.

- Administration of immunoglobulins and/or any blood products at any time prior to study
vaccination or planned administration during the study period ending at Day 30.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection.

- History of seizures or progressive neurological disorder, including infantile spasms,
uncontrolled epilepsy or progressive encephalopathy.

- Major congenital defects or serious chronic illness.

- Acute disease at the time of enrolment.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine(s).

- History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).

- Encephalopathy within 7 days of administration of previous dose of Infanrix or
Pediarix.

- Fever >=40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary)
within 48 hours of previous dose of Infanrix or Pediarix not due to another
identifiable cause.

- Collapse or shock-like state within 48 hours of previous dose of DTaP or
DTaP-containing vaccine.

- Persistent, severe, inconsolable screaming or crying lasting ³3 hours occurring within
48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.

- Thrombocytopenia following a previous dose of M-M-RII or its component vaccines

- Inability to contact a parent/guardian of the subject by telephone.

- Blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone
marrow or lymphatic systems.

- Family history of congenital or hereditary immunodeficiency, unless the immune
competence of the subject has been demonstrated.

- Residence in the same household as the following persons:

- New-born infants (0-4 weeks of age).

- Pregnant mother/women without documented positive history of chickenpox disease or
laboratory evidence of prior varicella vaccination.

- Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination
status or varicella disease history.

- Persons with known immunodeficiency.

- Active untreated tuberculosis.