Phase 3
Completed N=717
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
Pneumonia, Pneumococcal
Source: ClinicalTrials.gov NCT05420961 ↗
Enrolled (actual)
717
Serious AEs
1.8%
Results posted
May 2024
Primary outcomePrimary: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) — 7.4; 7.7; 7.5; 9.4 Percentage of Participants
◆ Published Evidence
Established
33citations · ~17 / year
A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6).
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.
Linked Publications
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A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6).
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.