• Percentage of Participants with a Solicited Injection-Site Adverse Event [ Time Frame: Day 1 to Day 14 post any vaccination ]
  An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be swelling, redness, pain or tenderness, and hard lump.
• Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Day 1 to Day 14 post any vaccination ]
  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be irritability, drowsiness, appetite loss, and hives or welts.
• Percentage of Participants with Vaccine-Related Serious Adverse Event [ Time Frame: Up to 6 months after Dose 3 (up to 194 days) ]
  An SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
• Percentage of Participants Meeting the Serotype Specific Immunoglobulin G (IgG) Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 [ Time Frame: 30 days after Dose 3 ]
  Assess the anti-pneumococcal polysaccharide (PnPs) serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL) for the 15 serotypes contained in V114 as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay.
• Geometric Mean Concentration (GMC) of Serotype-Specific IgG for Each Serotype in V114 [ Time Frame: 30 days after Dose 3 ]
  Assess the anti-PnPs serotype-specific IgG GMCs for the 15 serotypes contained in V114 as measured by the Pn ECL assay.

• Percentage of Participants Meeting the Antigen-Specific Antibody Threshold Value for each Antigen Included in Vaxelis™ [ Time Frame: 30 days after Dose 3 ]
  Assess the antibody responses to each antigen in Vaxelis™: diphtheria toxoid, tetanus toxoid, pertussis toxin (PT), pertussis filamentous hemagglutinin (FHA), pertussis fimbriae 2/3 (FIM 2/3), pertussis pertactin (PRN), Haemophilus influenzae type b polyribosylribitol phosphate (Hib-PRP), hepatitis B surface antigen (HBsAg), and poliovirus serotypes 1, 2, and 3. The percentage of participants administered V114 concomitantly with Vaxelis™ versus participants administered with Prevnar 13™ concomitantly with Vaxelis™ will be assessed.
• Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for each Serotype in V114 [ Time Frame: 30 days after Dose 2 ]
  Assess the anti-PnP serotype-specific IgG responses for the 15 serotypes contained in V114.
• GMC of Serotype-Specific IgG for Each Serotype in V114 [ Time Frame: 30 days after Dose 2 ]
  Assess the anti-PnPs serotype-specific IgG GMCs for the 15 serotypes contained in V114.
• Percentage of Participants Meeting the Serotype-Specific Opsonophagocytic Activity (OPA) Threshold Value for Each Serotype in V114 [ Time Frame: 30 days after Dose 3 ]
  Assess the anti-PnPs serotype-specific OPA responses for the 15 serotypes contained in V114.
• Geometric Mean Titer (GMT) of Serotype-Specific OPA for Each Serotype in V114 [ Time Frame: 30 days after Dose 3 ]
  Assess the anti-PnPs serotype-specific OPA GMTs for the 15 serotypes contained in V114.

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine (PCV) as one of the currently recommended by the World Health Organization (WHO) Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.

The primary hypotheses are that V114 is non-inferior to Prevnar 13® for the 13 shared serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; that V114 is superior to Prevnar 13® for the 2 serotypes unique to V114 based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™ administered concomitantly with Prevnar 13® at 30 days following Dose 3 for each antigen included in Vaxelis™.

• Drug: V114
  15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.
• Drug: Prevnar 13®
  13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
• Drug: Vaxelis™
  Intramuscular 0.5 mL single dose
• Drug: M-M-R®II
  Subcutaneous 0.5 mL single dose
  Other Name: Measles, Mumps, and Rubella Virus Vaccine Live
• Drug: Varivax®
  Subcutaneous 0.5 mL single dose
  Other Name: Varicella Vaccine Live

• Experimental: V114
  Infant participants will receive a single 0.5 mL intramuscular (IM) injection of V114 at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age).
  Interventions:

  • Drug: V114
  • Drug: Vaxelis™
  • Drug: M-M-R®II
  • Drug: Varivax®
• Active Comparator: Prevnar 13®
  Infant participants will receive a single 0.5 mL IM injection of Prevnar 13® at Visit 1, 2 and 4 (approximately 3, 5, and 12 months of age).
  Interventions:

  • Drug: Prevnar 13®
  • Drug: Vaxelis™
  • Drug: M-M-R®II
  • Drug: Varivax®

Inclusion Criteria:

• Is male or female, approximately 3 months of age, from 70 days to 111 days inclusive, at the time of signing the informed consent.
• 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:

• Was born prior to 37 weeks of gestation.
• Has a history of invasive pneumococcal disease (IPD) or known history of other culture positive pneumococcal disease.
• Has a 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.
• Has any contraindication to the concomitant study vaccines being administered in the study.
• Has a known or suspected impairment of immunological function.
• Has a 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.
• Has known or history of functional or anatomic asplenia.
• Has failure to thrive based on the clinical judgement of the investigator.
• Has a bleeding disorder contraindicating intramuscular vaccination.
• Has a 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).
• Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
• Has received a dose of any pneumococcal vaccine prior to study entry.
• Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry.
• Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenza type b conjugate vaccine, poliovirus vaccine, or any other combination thereof, prior to study entry.
• Has received a blood transfusion or blood products, including immunoglobulins.
• Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case by-case basis for approval by the Sponsor.
• Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
• Is or has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.