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, from 18 years to 49 years of age inclusive, 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 2040 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 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 <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 of 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 vaccine =30 days before receipt of study vaccine or is scheduled to receive any live 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety and tolerability profile of V116 as assessed by the proportion of participants with adverse events (AEs). 2. To compare the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination across 3 different lots of V116 for all serotypes included in V116.;Secondary Objective: 1. To evaluate the serotype-specific OPA GMTs at 30 days postvaccination in combined lots of V116 compared with PPSV23 for all serotypes included in V116. 2. To evaluate the serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days postvaccination compared across the 3 different lots of V116 and evaluate combined lots of V116 compared with PPSV23 for all serotypes included in V116. 3. To evaluate the serotype-specific geometric mean fold rises (GMFRs) and proportions of participants with a =4-fold rise from baseline to 30 days postvaccination for both OPA and IgG responses separately for 3 different lots of V116 for all serotypes included in V116. 4. To evaluate the serotype-specific OPA GMTs at 30 days postvaccination separately for 3 different lots of V116 for cross-reactive immune responses to serotypes within a serogroup.;Primary end point(s): 1. Percentage of participants with solicited injection-site adverse events (AEs) 2. Percentage of participants with solicited systemic AEs 3. Percentage of participants with vaccine-related serious adverse events (SAEs) 4. Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with 1 of 3 different lots of V116;Timepoint(s) of evaluation of this end point: 1. Up to ~5 days 2. Up to ~5 days 3. Up to ~6 months 4. Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAXTM 2. Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots 3. GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PNEUMOVAXTM 4. Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots 5. Percentage of participants with =4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots 6. GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots 7. Percentage of participants with =4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots 8. GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots;Timepoint(s) of evaluation of this end point: 1. Day 30 2. Day 30 3. Day 30 4. Baseline (Day 1) and Day 30 5. Baseline (Day 1) and Day 30 6. Baseline (Day 1) and Day 30 7. Baseline (Day 1) and Day 30 8. Day 30 | — |
Countries
Austria, Canada, Denmark, Finland, Israel, Poland, Spain, United States
Contacts
Public ContactPaul Scott
Merck Sharp & Dohme LLC
Outcome results
None listed