Prevention of pneumococcal invasive disease, pneumococcal pneumonia, and otitis media caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, 1, 5, 7F, 3, 6A, 19A, 22F, 33F) in infants and toddlers. MedDRA version: 12.1 Level: LLT Classification code 10054047 Term: Pneumococcal sepsis MedDRA version: 12.1 Level: LLT Classification code 10058886 Term: Pneumococcal bacteremia MedDRA version: 12.1 Level: LLT Classification code 10027253 Term: Meningiti
Conditions
Interventions
Product Name: V114 adjuvanted Pneumococcal 15-valent Conjugate Vaccine (Diphtheria CRM 197 Protein)
Product Code: V114
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified pneum
Sponsors
MSD Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults: Adults =18 to 45 years of age in good health. Afebrile (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Adults: 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, 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. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Subjects 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. Subject 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. 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. Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. Female subjects 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 other reason that in the opinion of the investigator may interfere with the evaluation required by the study. Toddlers: 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. Subject has a history of congenital or acquired immunodeficiency (e.g. splenomegaly). Subject or his/her mother has documented HIV infection. Functional or anatomic asplenia. History of autoimmune disease. 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 subject is receiving less than 2mg/kg per day of prednisone (or its equivalent), or less than 20mg/d if they weigh more than 10kg and are not otherwise immunocompromised. Prior receipt of a blood transfusion or blood products, including immunoglobulins. History of invasive pneumococcal d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Adult Stage: Evaluate the safety profile of a single dose of the aluminum-adjuvanted formulation of V114 pneumococcal conjugate vaccine in healthy adults. Toddler Stage: Evaluate the safety profile of a single booster dose of the aluminum-adjuvanted, and the non-adjuvanted formulation of V114 versus Prevnar™ administered at 12-15 months of age in healthy toddlers. ;Secondary Objective: Immunogenicity: To describe the immunogenicity response to the serotypes contained in V114 in both adults and toddlers as measured by the MSD electrochemiluminescence (ECL) assay for the measurement of serotype-specific pneumococcal capsular polysaccharide IgG antibodies. Sera will also be assayed by a multiplex OPA for opsonophagocytic killing activity. The main immunogenicity measurement is the pneumococcal capsular polysaccharide IgG concentration as measured by the electrochemiluminescence (ECL) assay, and corresponding to the 0.35 µg/mL level as measured by the internationally accepted ELISA. This is a descriptive study; therefore, there is no hypothesis. ;Primary end point(s): Safety: frequency of adverse events. For adults, safety endpoints will also include those based on chemistry, and hematology and urinalysis laboratory values. Immunogenicity: The main summary of immunogenicity will be based on the postvaccination percentage of subjects with =0.35 µg/mL IgG concentration, for all serotypes. Secondary endpoints of interest are the geometric mean concentrations of IgG, the precent of subjects with OPA activity as defined by =1:8 and the geometric mean OPA titers. | — |
Countries
Finland
Outcome results
None listed