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Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older

NCT05569954•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

Detailed Description

Selected participants may be eligible for optional immunogenicity or PBMC substudies extension that will investigate the exploratory objectives.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy

Exclusion Criteria

•Has a history of invasive pneumococcal disease (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)
•Has a known hypersensitivity to any component of V116 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 IM vaccination
•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
•Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
•Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
•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
•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
•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 (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
+2 more criteria

Locations (55)

Fundacion Estudios Clinicos ( Site 0200)

Rosario, Santa Fe Province, Argentina

Paratus Clinical Research Western Sydney ( Site 1500)

Blacktown, New South Wales, Australia

Northern Beaches Clinical Research ( Site 1502)

Brookvale, New South Wales, Australia

Paratus Clinical Research Brisbane ( Site 1501)

Albion, Queensland, Australia

IPS Centro Científico Asistencial S.A.S ( Site 0407)

Barranquilla, Atlántico, Colombia

Fundacion Valle del Lili- CIC ( Site 0415)

Cali, Valle del Cauca Department, Colombia

klinikum rechts der isar der technischen universität münchen ( Site 0904)

München, Bavaria, Germany

InfektioResearch ( Site 0903)

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Koeln ( Site 0900)

Cologne, North Rhine-Westphalia, Germany

Medizentrum Essen Borbeck ( Site 0902)

Essen, North Rhine-Westphalia, Germany

Key Dates

Start Date

November 7, 2022

Primary Completion Date

October 30, 2023

Completion Date

February 7, 2025

Last Updated

March 2, 2026

Enrollment

1,484

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

V116

BIOLOGICAL

PPSV23

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

View study

ACTIVE_NOT_RECRUITING

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: March 2, 2026Data 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.

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Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age