Pneumococcal disease MedDRA version: 20.0 Level: LLT Classification code 10035644 Term: Pneumococcal infection NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: PNEUMOVAX® 23 (pneumococcal vaccine polyvalent)
Product Name: -
Product Code: [-]
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: -
Concentration un
Sponsors
MERCK SHARP & DOHME LLC. UNA SUSSIDIARIA DI MERCK & CO. INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant may have underlying chronic conditions if they are assessed to be stable as per the investigator’s judgment. 2. Is pneumococcal vaccine-experienced, defined as prior receipt (>=1 year before enrollment) of PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23. 3. Is male or female, >=50 years of age, at the time of informed consent. 4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Not a WOCBP OR • A WOCBP and: - Uses an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 6 weeks after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. - Medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy. 5. The participant (or legally acceptable representative) has provided documented informed consent for the study. The participant may also provide documented informed consent for FBR and/or assay development sample collection. However, the participant may be enrolled in the study without providing consent for FBR or assay development sample collection. 6. The participant has the ability to complete eVRC data collection without assistance based on judgment of the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1. Has a history of IPD (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1). 2. Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid. 3. Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented HIV infection, functional or anatomic asplenia, or history of autoimmune disease. 4. Has a coagulation disorder contraindicating intramuscular vaccination. 5. *Had a recent febrile illness (defined as oral or tympanic temperature >=100.4°F [>=38.0°C] or axillary or temporal temperature >=99.4°F [>=37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine. 6. Has a known malignancy that is progressing or has required active treatment within the 3 years prior to signing the informed consent. 7. Received PPSV23 followed by either PCV15 or PCV20. 8. *Received systemic corticosteroids (prednisone equivalent of >=20 mg/day) for >=14 consecutive days and has not completed intervention >=14 days before receipt of study vaccine. 9. Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. 10. *Received any nonlive vaccine =7 days before or >=15 days after receipt of study vaccine. 11. *Received any live virus vaccine <=30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine <=30 days after receipt of study vaccine. 12. Received a blood transfusion or blood products, including immunoglobulin <=6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete. Autologous blood transfusions are not considered an exclusion criterion. 13. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. 14. In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities. 15. Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study. 16. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1 may be rescheduled for a time when these criteria are not met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate the serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days postvaccination for all serotypes included in V116 2. To evaluate the serotype-specific geometric mean fold rise (GMFR) and the proportion of participants who achieve a serotype-specific >=4-fold increase from baseline to 30 days postvaccination for both OPA and IgG responses for all serotypes included in V116;Primary end point(s): 1. Number of Participants With a Solicited Injection-site Adverse Event (AE) From Day 1 Through Day 5 Postvaccination 2. Number of Participants With a Solicited Systemic Adverse Event (AE) From Day 1 Through Day 5 Postvaccination 3. Number of Participants With a Vaccine-related Serious Adverse Event (SAE) 4. Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30 Postvaccination;Timepoint(s) of evaluation of this end point: 1. Up to 5 days postvaccination 2. Up to 5 days postvaccination 3. Up to 180 days postvaccination 4. Day 30 postvaccination;Main Objective: 1. To evaluate the safety and tolerability of V116 as assessed by the proportion of participants with adverse events (AEs) 2. To evaluate the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days postvaccination for all serotypes included in V116 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30 Postvaccination 2. Number of Participants With a >=4 Fold Increase From Baseline to Day 30 Postvaccination in Serotype-specific Opsonophagocytic Activity (OPA) Titer 3. Number of Participants With >=4 Fold Increase From Baseline to Day 30 Postvaccination in Serotype specific Immunoglobulin G (IgG) Concentration 4. Geometric Mean Fold Rise (GMFR) From Baseline to Day 30 Postvaccination in Serotype-specific Opsonophagocytic Activity (OPA) Titer 5. Geometric Mean Fold Rise (GMFR) From Baseline to Day 30 Postvaccination in Serotype-specific Immunoglobulin G (IgG) Concentration;Timepoint(s) of evaluation of this end point: 1. Day 30 postvaccination 2. Day 1 (baseline) and Day 30 postvaccination 3. Day 1 (baseline) and Day 30 postvaccination 4. Day 1 (baseline) and Day 30 postvaccination 5. Day 1 (baseline) and Day 30 postvaccination | — |
Countries
Canada, France, Israel, Italy, Japan, Korea, Republic of, Spain, Taiwan, United States
Contacts
Public ContactDivisione Ricerca Clinica
MSD Italia Srl
Outcome results
None listed