E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prevention of invasive pneumococcal disease and pneumococcal pneumonia 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 adults. |
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E.1.1.1 | Medical condition in easily understood language |
pneumococcal disease including pneumococcal sepsis, pneumococcal bacteremia, pneumococcal meningitis, and pneumococcal pneumonia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035728 |
E.1.2 | Term | Pneumonia pneumococcal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054047 |
E.1.2 | Term | Pneumococcal sepsis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058886 |
E.1.2 | Term | Pneumococcal bacteremia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027253 |
E.1.2 | Term | Meningitis pneumococcal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that the safety profile of a single dose of V114 is acceptable. To compare serotype-specific IgG geometric mean concentrations (GMCs), as measured by Merck’s pneumococcal electrochemiluminescence (Pn ECL) assay between recipients of a single dose of V114 and a single dose of PNEUMOVAX™ 23 for the 14 shared serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F), as measured at 1 month postvaccination. |
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E.2.2 | Secondary objectives of the trial |
Compare functional pneumococcal capsular polysaccharide antibody Geometric Mean Titers (GMTs) by Multiplex Opsonphagocytic (MOPA-4) assay for the 14 serotypes in common between recipients of a single dose of V114 and a single dose of PNEUMOVAX™ 23 at one month postvaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Man or woman in good health.
2. Age ≥50 years.
3. Informed consent signed and dated prior to any study procedures being performed. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in the Future Biomedical Research.
4. Afebrile (<100.4oF [<38.0oC] oral or equivalent) for 72 hours prior to vaccination.
5. Subject is able to read, understand, and complete the study questionnaires (i.e., the VRC).
6. Subject is able to attend all scheduled visits and to comply with the study procedures.
7. Subject is highly unlikely to conceive at any time from signing the informed consent through 6 weeks after receiving the last dose of the study vaccine, as indicated by at least one “yes” answer to the following questions:
a. Subject is male.
b. Subject is a female who agrees to remain abstinent or use (or have her partner use) 2 acceptable methods of contraception during the time period at any time from signing the informed consent through 6 weeks after receiving the study vaccine. Acceptable methods of birth control are: hormonal contraceptives, diaphragm with spermicide, intrauterine device (IUD), contraceptive sponge, condom, or vasectomy. Note that simultaneous use of 2 reliable forms of contraception is recommended.
c. Subject is a female who is not of reproductive potential. A female subject who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) post-surgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation.
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E.4 | Principal exclusion criteria |
1. Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine.
2. Known hypersensitivity to any component of the pneumococcal conjugate vaccine or of the pneumococcal polysaccharide vaccine.
3. 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), nephrotic syndrome, or other conditions associated with immunosuppression, such as organ or bone marrow transplant.
4. Functional or anatomic asplenia.
5. History of autoimmune disease.
6. Subject has a coagulation disorder contraindicating intramuscular vaccinations.
7. Subject has evidence of dementia or other cognitive impairment.
8. Subject has insufficient muscle mass in the deltoid muscle of either arm or an inability to grade limitation of arm movement as required with postvaccination clinical monitoring.
9. 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., >20 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.
10. Any underlying illness that would complicate evaluation and completion of this study.
11. Any licensed non-live 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.
12. Subject has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine.
13. Subject has received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine.
14. Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
15. Investigational drugs or vaccines received within the 2 months before receipt of study vaccine or is scheduled to receive an investigational drug or vaccines within 30 days of receipt of study vaccine..
16. Subject intends to participate in another interventional clinical study anytime during the duration of the current clinical study (participation in an observational or safety surveillance study is acceptable).
17. 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.
18. Subject has received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine.
19. Subject is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.
20. Subject resides in a nursing home or long-term care facility or requires semi-skilled nursing care. (A resident of a retirement community who is otherwise ambulatory could be eligible.)
21. Any subject who cannot be adequately followed for safety according to the protocol.
22. Subject is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
23. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ratio of serotype-specific pneumococcal capsular polysaccharide IgG GMCs [V114 / PNEUMOVAX™ 23] in the Pn ECL assay at 1 month postvaccination for 14 common serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 prior to vaccination and Day 30 postvaccination |
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E.5.2 | Secondary end point(s) |
Ratio of serotype-specific functional pneumococcal capsular polysaccharide antibody GMTs [V114 / PNEUMOVAX™ 23] in the MOPA-4 assay at 1 month postvaccination for 14 common serotypes ((1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 prior to vaccination and Day 30 postvaccination |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Prevenar 13™, PNEUMOVAX™ 23 |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Israel |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |