Phase 3
N=717
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Pneumonia, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT05420961 ↗Enrolled (actual)
717
Serious AEs
1.8%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) — 7.4; 7.7; 7.5; 9.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V116 (Biological); PCV15 (Biological); PPSV23 (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-site Adverse Events (AEs) |
7.4; 7.7; 7.5; 9.4; 7.6; 35.7 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs |
14.3; 17.1; 19.0; 12.9; 21.9; 7.0 | — |
| PRIMARY Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) |
0.4; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) |
262.1; 226.3; 391.1; 583.1; 318.3; 1653.5 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) |
0.87; 0.80; 0.89; 1.58; 0.85; 4.69 | — |
| SECONDARY Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) |
4.4; 4.0; 6.2; 7.5; 5.0; 6.2 | — |
| SECONDARY Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses |
54.9; 54.9; 64.1; 66.2; 48.7; 57.9 | — |
| SECONDARY Geometric Mean Fold Rise of Serotype-specific IgG |
3.6; 3.1; 3.7; 5.7; 2.9; 5.9 | — |
| SECONDARY Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response |
42.7; 36.8; 40.7; 54.3; 35.4; 56.2 | — |
Summary
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Exclusion Criteria
- Has a history of invasive pneumococcal disease (IPD).
- Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid.
- Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease.
- Has a coagulation disorder contraindicating intramuscular vaccination.
- Has a known malignancy that is progressing or has required active treatment.
- Has received PPSV23 followed by either PCV15 or PCV20.
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
- 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.
- Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
- Has 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.
- Has 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 post-vaccination blood draw is complete.
Data sourced from ClinicalTrials.gov (NCT05420961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.