Pneumococcal disease MedDRA version: 20.0 Level: LLT Classification code 10035644 Term: Pneumococcal infection NOS System Organ Class: 100000004862
Conditions
Sponsors
Merck Sharp & Dohme LLC
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 male or female, =18 years of age, at the time of informed consent. 3. 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. 4. 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. 5. 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 1450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1150
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 or PCV20, 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 IM 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 <72 hours before receipt of study vaccine. 6. Has a known malignancy that is progressing or has required active treatment <3 years before enrollment. 7. Received prior administration of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol. Exception: participants with childhood pneumococcal vaccination prior to the age of 5 will be permitted. 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 =14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine =30 days after receipt of study vaccine. Exception: inactivated influenza vaccine and SARS-CoV-2 mRNA or SARS-CoV-2 protein subunit vaccine may be administered but must be given =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 whe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To evaluate the safety and tolerability of V116 as assessed by the proportion of participants with adverse events (AEs) [Cohorts 1 and 2 separately] 2.To compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) at 30 days postvaccination with V116 versus PCV20 (Cohort 1) 3.To compare the proportions of participants with a =4-fold rise in serotype-specific OPA responses from baseline to 30 days postvaccination with V116 versus PCV20 for the unique serotypes in V116 (Cohort 1);Secondary Objective: 1.To compare the serotype-specific OPA GMTs in adults 18 to 49 years of age from Cohort 2 versus adults 50 to 64 years of age from Cohort 1 at 30 days postvaccination with V116 (Cohort 2) 2.To evaluate serotype-specific cross-reactive OPA responses at 30 days postvaccination with V116 in adults =50 years of age from Cohort 1 and adults 18 to 49 years of age from Cohort 2 for serotypes within a serogroup (Cohorts 1 and 2) 3.To evaluate the serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days postvaccination with V116 compared with PCV20 (Cohort 1) 4.To evaluate the serotype-specific geometric mean fold rise (GMFR) and proportions of participants with a =4-fold rise in serotype-specific OPA and IgG responses from baseline to 30 days postvaccination with V116 and separately for PCV20 (Cohort 1);Primary end point(s): 1. Percentage of participants with injection-site AEs 2. Percentage of participants with systemic AEs 3. Percentage of participants with vaccine-related serious AE (SAE) 4. Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohort 1 5. Percentage of participants with =4-fold rise from baseline in serotype-specific OPAs in Cohort 1;Timepoint(s) of evaluation of this end point: 1. Up to 5 days postvaccination 2. Up to 5 days postvaccination 3. Up to 194 days postvaccination 4. Day 30 postvaccination 5. Baseline and Day 30 postvaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Serotype-specific OPA GMTs in adults 18 to 49 years of age in Cohort 2 2. Serotype-specific cross-reactive OPA GMTs in adults =50 years of age (Cohort 1) and adults 18 to 49 years of age (Cohort 2) 3. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1 4. Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs (Cohort 1) 5. GMFR from baseline in serotype-specific IgG GMCs (Cohort 1) 6. Percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs 7. Percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs;Timepoint(s) of evaluation of this end point: 1. Day 30 postvaccination 2. Day 30 postvaccination 3. Day 30 postvaccination 4. Baseline and Day 30 postvaccination 5. Baseline and Day 30 postvaccination 6. Baseline and Day 30 postvaccination 7. Baseline and Day 30 postvaccination | — |
Countries
Australia, Belgium, Chile, Germany, Korea, Republic of, New Zealand, Puerto Rico, Sweden, Taiwan, Turkey, United States
Outcome results
None listed