A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-… (NCT05420961) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
United States717 participantsStarted 2022-07-12
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stu…
What they're measuring
1
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Timeframe: Up to 5 days post-vaccination
2
Percentage of Participants With Solicited Systemic AEs
Timeframe: Up to 5 days post-vaccination
3
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Timeframe: Up to ~180 days
4
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)