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COMPLETEDPHASE3

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

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

NCT05420961•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Detailed Description

Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

Locations (51)

Central Research Associates ( Site 0024)

Birmingham, Alabama, United States

Lenzmeier Family Medicine/CCT Research ( Site 0008)

Glendale, Arizona, United States

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)

Tempe, Arizona, United States

Southland Clinical Research Center ( Site 0026)

Fountain Valley, California, United States

Diablo Clinical Research, Inc. ( Site 0019)

Walnut Creek, California, United States

Alliance for Multispecialty Research, LLC ( Site 0020)

Coral Gables, Florida, United States

Indago Research & Health Center, Inc ( Site 0005)

Hialeah, Florida, United States

Advanced Medical Research Institute ( Site 0018)

Miami, Florida, United States

Solaris Clinical Research ( Site 0025)

Meridian, Idaho, United States

Centennial Medical Group ( Site 0002)

Elkridge, Maryland, United States

Key Dates

Start Date

July 12, 2022

Primary Completion Date

May 16, 2023

Completion Date

May 16, 2023

Last Updated

October 26, 2024

Enrollment

717

ACTUAL participants

Conditions

Pneumonia, Pneumococcal

Interventions

V116

BIOLOGICAL

PCV15

BIOLOGICAL

PPSV23

BIOLOGICAL

Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)

NCT04909268

Pneumonia, PneumococcalHiv

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TERMINATED

Myocardial Injury and Severe Pneumococcal Pneumonia

NCT03058211

Pneumonia, PneumococcalMyocardial Ischemia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

Inclusion Criteria

Exclusion Criteria

Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)

Myocardial Injury and Severe Pneumococcal Pneumonia

An Epidemiological Survey to Establish the Spectrum of Circulating Serotypes of S. Pneumoniae, in Patients Older 18 Years

Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults