Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Prevnar™; V114, Aluminum Adjuvanted; V114, Aluminum Nonadjuvanted
Intervention description: 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 150.0
Sex: All
Minimum age: 12 Months
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pneumococcal vaccines

Summary:

      This study is being conducted to evaluate the safety, tolerability, and immunogenicity of
      15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and
      toddlers.
    

Eligibility criteria:

        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 (<100.4°F [<38.0°C] oral or equivalent) on day of vaccination.

          -  Participant is able to read, understand, and complete study questionnaires (i.e., the
             Vaccine Report Card).

          -  Participant is able to attend all scheduled visits and to comply with the study
             procedures.

          -  Participant has access to a telephone.

          -  Females must have a negative urine pregnancy test.

        Toddler Stage:

          -  Healthy toddlers, 12-15 months of age who have previously completed a documented full
             3 dose infant series of Prevnar™ at 2, 4, and 6 months of age.

          -  Participant's parent/legal guardian understands the study procedures, alternate
             treatments available and risks involved with the study, and voluntarily agrees to
             participate by giving written informed consent.

          -  Afebrile, with a rectal temperature <38.1°C (<100.5°F) or axillary temperature <37.8°C
             (<100.0°F) on day of vaccination.

          -  Participant's parent/legal guardian is able to read, understand, and complete study
             questionnaires (i.e., the Vaccination Report Card).

          -  Participant is able to attend all scheduled visits and to comply with the study
             procedures.

          -  Participant's parent/legal guardian has access to a telephone.

        Exclusion criteria:

        Adult Stage:

          -  Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of
             polysaccharide conjugate vaccine after the second year of life.

          -  Known hypersensitivity to any component of the pneumococcal conjugate vaccine.

          -  Known or suspected immunocompromised persons, including persons with congenital
             immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma,
             Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure
             (most recent serum creatinine values in medical record ≥3 mg/dL), nephritic syndrome,
             or other conditions associated with immunosuppression such as organ or bone marrow
             transplant.

          -  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.

          -  History of chronic fatigue syndrome.

          -  Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS),
             MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis (ADEM),
             pervasive developmental disorder, and related disorders.

          -  Participant has a coagulation disorder contraindicating IM vaccination.

          -  Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are
             permitted). Participants on corticosteroids should be excluded if they are receiving
             or are expected to receive, in the period from 30 days prior to Visit 1 through Visit
             2, systemic doses greater than required for physiological replacement, i.e., >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 inhaled/nebulized steroids
             may participate in the study.) Use of systemic steroids are only permitted when the
             participant is receiving less than 2 mg/kg per day of prednisone (or its equivalent),
             or less than 20 mg/d if they weigh more than 10 kg and are not otherwise
             immunocompromised.

          -  Participant has received other licensed non-live vaccines administered within the 14
             days before receipt of study vaccine.

          -  Participant has received a licensed live virus vaccine within 30 days prior of receipt
             of study vaccine (Exception: Influenza virus vaccine given according to recommended
             guidelines within 7 days of receiving study vaccine).

          -  Prior receipt of a blood transfusion or blood products, including immunoglobulins.

          -  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.

          -  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.

          -  A recent (<72 hours) febrile illness (rectal temperature ≥38.1°C [≥100.5°F]) occurring
             within 48 hours before receipt of study vaccine.

          -  History of failure to thrive.

          -  Participant has a coagulation disorder contraindicating IM vaccination.

          -  Participant and his/her mother is documented hepatitis B surface antigen-positive.

          -  Any toddler who cannot be adequately followed for safety according to the protocol
             plan.

          -  Participant's parent/legal guardian 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.