A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

Inclusion Criteria:

- Healthy, based on clinical judgment of the investigator

- Has a legally acceptable representative who understands the study procedures,
alternate treatments available, and risks involved with the study and voluntarily
agrees to participate by giving written informed consent.

Exclusion Criteria:

- History of invasive pneumococcal disease (positive blood culture, positive
cerebrospinal fluid culture, or other sterile site) or known history of other culture
positive pneumococcal disease

- Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV),
any component of the licensed pediatric vaccines to be administered concomitantly in
the study, or any diphtheria toxoid-containing vaccine

- Any contraindication to the concomitant study vaccines being administered in the study

- Known or suspected impairment of immunological function

- History of congenital or acquired immunodeficiency

- Has or his/her mother has a documented human immunodeficiency virus (HIV) infection

- Has or his/her mother has a documented hepatitis B surface antigen - positive test

- Known or history of functional or anatomic asplenia

- Failure to thrive based on the clinical judgment of the investigator

- Known coagulation disorder contraindicating intramuscular vaccination

- History of autoimmune disease (including but not limited to systemic lupus
erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid
disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or
other autoimmune disorders)

- Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis,
acute disseminating encephalomyelitis, pervasive development disorder, and related
disorders

- Received a dose of any pneumococcal vaccine prior to study entry

- Received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination
vaccine prior to study entry

- Received a dose of rotavirus vaccine prior to study entry

- Received a blood transfusion or blood products, including immunoglobulins

- Participated in another clinical study of an investigational product before the
beginning or anytime during the duration of the current clinical study

- Has any other reason that, in the opinion of the investigator, may interfere with the
evaluation required by the study

- Has an immediate family member (e.g., parent/legal guardian or sibling) who is
investigational site or Sponsor staff directly involved with this study.