Clinical trial NCT05464420: A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Official title: A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 2162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.

The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.


Eligibility criteria: The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has underlying chronic conditions but assessed to be stable as per investigator
* Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator

Exclusion Criteria:

* Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Has a coagulation disorder contraindicating intramuscular vaccination
* Has a recent illness with fever
* Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
* Is expected to receive any pneumococcal vaccine during the study outside of the protocol
* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
* 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 study vaccine
* Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots
timeFrame: Up to 5 days
measure: Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23
timeFrame: Up to 5 days
measure: Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots
timeFrame: Up to 5 days
measure: Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23
timeFrame: Up to 5 days
measure: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots
timeFrame: Up to 194 days
measure: Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23
timeFrame: Up to 194 days
measure: Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Day 30
Secondary outcomes:
measure: GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
timeFrame: Day 30
measure: Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Day 30
measure: GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
timeFrame: Day 30
measure: Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Baseline (Day 1) and Day 30
measure: Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Baseline (Day 1) and Day 30
measure: GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Baseline (Day 1) and Day 30
measure: Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
timeFrame: Baseline (Day 1) and Day 30
measure: GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots
timeFrame: Day 30
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Desert Clinical Research/ CCT Research ( Site 0019)
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research ( Site 0015)
state: Arkansas
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc. ( Site 0023)
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research ( Site 0027)
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials ( Site 0004)
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc. ( Site 0022)
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver ( Site 0003)
state: Colorado
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0011)
state: Florida
city: Miami
country: United States
facility: L&C Professional Medical Research Institute ( Site 0012)
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando ( Site 0017)
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida ( Site 0001)
state: Florida
city: Rexburg
country: United States
facility: Clinical Research Prime Rexburg ( Site 0040)
state: Idaho
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago ( Site 0006)
state: Illinois
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research ( Site 0036)
state: Kentucky
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0031)
state: Missouri
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research ( Site 0029)
state: Nebraska
city: Las Vegas
country: United States
facility: Healor Primary Care / CCT Research ( Site 0028)
state: Nevada
city: Santa Fe
country: United States
facility: Axces Research ( Site 0034)
state: New Mexico
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc. ( Site 0033)
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research Associates ( Site 0035)
state: North Carolina
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute ( Site 0014)
state: Oklahoma
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence ( Site 0018)
state: Rhode Island
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville ( Site 0021)
state: South Carolina
city: Nashville
country: United States
facility: Clinical Research Associates Inc ( Site 0039)
state: Tennessee
city: Longview
country: United States
facility: DCOL Center for Clinical Research ( Site 0025)
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio ( Site 0020)
state: Texas
city: Tomball
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research ( Site 0013)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0002)
state: Virginia
city: Graz
country: Austria
facility: Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck ( Site 0301)
state: Tirol
city: Vienna
country: Austria
facility: Tropeninstitut Wien 1060 ( Site 0300)
state: Wien
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 0302)
city: Truro
country: Canada
facility: Colchester Research Group ( Site 0202)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group ( Site 0208)
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc. ( Site 0201)
state: Ontario
city: Toronto
country: Canada
facility: Manna Research Toronto ( Site 0209)
state: Ontario
city: Mirabel
country: Canada
facility: Manna Research Mirabel ( Site 0207)
state: Quebec
city: Pointe-Claire
country: Canada
facility: Manna Research Montreal ( Site 0203)
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc. ( Site 0204)
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Diex Recherche Trois-Rivieres ( Site 0206)
state: Quebec
city: Herlev
country: Denmark
facility: Sanos Clinic-Sanos Clinic ( Site 0402)
state: Hovedstaden
city: Soborg
country: Denmark
facility: Danske Lægers Vaccinations Service - Søborg ( Site 0404)
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Danske Lægers Vaccinations Service - Århus ( Site 0403)
state: Midtjylland
city: Aalborg
country: Denmark
facility: Sanos Clinic - Nordjylland ( Site 0401)
state: Nordjylland
city: Vejle
country: Denmark
facility: Sanos Clinic - Syddanmark ( Site 0400)
state: Syddanmark
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka ( Site 0501)
state: Pohjois-Pohjanmaa
city: Pori
country: Finland
facility: FVR, Porin rokotetutkimusklinikka ( Site 0508)
state: Satakunta
city: Seinajoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)
state: Sodra Osterbotten
city: Espoo
country: Finland
facility: FVR, Espoon rokotetutkimusklinikka ( Site 0509)
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)
state: Uusimaa
city: Helsinki
country: Finland
facility: Helsinki East Vaccine Research Clinic ( Site 0502)
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka ( Site 0500)
state: Varsinais-Suomi
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0603)
city: Jerusalem
country: Israel
facility: Maccabi Healthcare Services ( Site 0606)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center ( Site 0600)
city: Kfar Saba
country: Israel
facility: Meir Medical Center ( Site 0601)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)
city: Sakhnin
country: Israel
facility: Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)
city: Bydgoszcz
country: Poland
facility: IN VIVO ( Site 0711)
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun ( Site 0706)
state: Kujawsko-pomorskie
city: Skierniewice
country: Poland
facility: Clinmedica OMC ( Site 0701)
state: Lodzkie
city: Lublin
country: Poland
facility: Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)
state: Lubelskie
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk ( Site 0704)
state: Podkarpackie
city: Centelles
country: Spain
facility: EBA CENTELLES ( Site 0800)
state: Cataluna
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)
state: Madrid
city: València
country: Spain
facility: Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)
city: Barcelona
country: Spain
facility: EAP Sardenya ( Site 0802)
city: Madrid
country: Spain
facility: Hospital La Princesa-Clinical Pharmacology ( Site 0815)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: