A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

• Pneumococcal Vaccines
• Pneumococcal Conjugate Vaccine

• Biological: 13-valent pneumococcal conjugate vaccine
  A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
  Other Name: 13vPnC
• Biological: 23-valent pneumococcal polysaccharide vaccine
  A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
  Other Name: 23VPS

• Experimental: >= 65-year age group-13vPnC
  Intervention: Biological: 13-valent pneumococcal conjugate vaccine
• Active Comparator: >= 65-year age group-23vPS
  Intervention: Biological: 23-valent pneumococcal polysaccharide vaccine

Inclusion Criteria:

1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria:

1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
3. Documented Streptococcus pneumoniae infection within the past 5 years.
4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.