Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

Inclusion criteria

Adult Stage:

• Adults ≥18 to 45 years of age in good health.
• Signed and dated informed consent prior to receipt of vaccine.
• Afebrile ( 5 mg of prednisone (or equivalent) daily and for >2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease.
• Any underlying illness that would complicate evaluation and completion of this study.
• Any licensed non-live virus vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.)
• Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive vaccination with a licensed live virus vaccine within 30 days of receipt of study vaccine.
• Participant has received diphtheria toxoid within 6 months prior to receipt of study vaccine.
• Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine.
• Investigational drugs or vaccines received within the 2 months before receipt of study vaccine.
• Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study.
• Recent hospitalization for acute illness within the 3 months before receipt of study vaccine.
• 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.
• History of febrile illness (≥100.40 F [≥38.00 C] oral or equivalent) occurring within 72 hours before receipt of study vaccine.
• Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. Female participants of reproductive potential must have been using 2 acceptable methods of birth control for 2 weeks prior to enrollment, and agree to use 2 acceptable methods of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence).
• Any participant who cannot be adequately followed for safety according to the protocol plan.
• Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
• Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.

Toddler Stage:

• Have received less than the full 3-dose infant series of Prevnar™ or 3rd dose less than 2 months before study vaccine.
• Known hypersensitivity to any component of the pneumococcal conjugate vaccine.
• Known or suspected impairment of immunological function.
• Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly).
• Participant or his/her mother has documented HIV infection.
• Functional or anatomic asplenia.
• History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders.
• Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders.
• Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note: Toddlers on topical and inhal