Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

The subjects from this study will participate in one of three cohorts:

- US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and
booster phases will be evaluated in this cohort. These subjects will also contribute to
the safety analyses in the primary and booster phases.

- Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and
booster phases for this cohort.

- Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in
the primary and booster phases will be reported for this cohort. These subjects will
also contribute to the safety analyses in the primary and booster phases.

Treatment allocation:

Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4
treatment groups and with a stratification according to the cohort. Assignment to a cohort
will be based on study site.

Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a
booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will
receive a booster dose of PedvaxHIB.

During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or
rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose
3.

During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and
influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration
of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2
and 3.

The study will be conducted in a double-blind fashion with regard to consistency of the 3
manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine
versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all
data pertaining to the period up to one month after booster vaccination. Therefore, the
extended safety follow-up after the booster dose will be conducted in an unblinded manner.
The person administering the vaccines will ensure that the parent/guardian does not see the
vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations
of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study
personnel who administer the vaccines.

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.