Clinical trial NCT05526716: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)
Official title: A Phase 3 Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia, Pneumococcal
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-09-02
Enrollment: 1080
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This a study of V116 in adults ≥50 years of age who concomitantly received Influenza vaccine. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with Quadrivalent Influenza Vaccine (QIV) compared with V116 administered sequentially with QIV. The primary hypotheses state that immune responses to V116 and to QIV are non-inferior when administered concomitantly as compared with sequential administration as measured by serotype-specific opsonophagocytic activity (OPA) for V116 and hemagglutination inhibition (HAI) geometric mean titers (GMTs) for QIV, at 30 days postvaccination.


Eligibility criteria: Inclusion Criteria:

* Any underlying chronic conditions were assessed to be in stable condition per the investigator's judgment
* Females: Not pregnant or a breast feeding and not a woman of childbearing potential (WOCBP) or a WOCBP agrees to use contraception or remain abstinent

Exclusion Criteria:

* History of IPD or other culture-positive pneumococcal disease
* Known or suspected impairment of immunological function
* Receipt of systemic corticosteroids or immunosuppressive therapy
* Received any pneumococcal vaccine \<12 months prior to enrollment
* Prior administration of PCV15 or PCV20
* Received any influenza vaccine \<6 months prior to enrollment

Primary outcomes:
measure: Number of Participants With Solicited Injection-site Adverse Events (AEs)
timeFrame: Up to 5 days post-vaccination
measure: Number of Participants With Solicited Systemic AEs
timeFrame: Up to 5 days post-vaccination
measure: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
timeFrame: Up to ~6 months postvaccination with V116
measure: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Responses
timeFrame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
measure: GMT of Influenza Strain-specific Hemagglutination Inhibition (HAI)
timeFrame: Day 30
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
timeFrame: 30 days after V116 vaccination (Day 30 for concomitant group and Day 59 for sequential group)
measure: Geometric Mean Fold Rise (GMFR) Ratio of Serotype-specific OPA
timeFrame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
measure: GMFR Ratio of Serotype-specific IgG
timeFrame: Baseline (Day 1 for the concomitant group and Day 30 for the sequential group) and Postvaccination (Day 30 for the concomitant group and Day 59 for the sequential group)
measure: GMFR in Influenza Strain-specific HAI
timeFrame: Day 1 (Baseline) and Day 30 (Postvaccination)
measure: Percentage of Participants Who Seroconvert for Influenza Strain-specific HAI Titer ≥1:40
timeFrame: Day 30
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012)
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc. ( Site 0070)
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc ( Site 0024)
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC ( Site 0067)
state: California
city: Newport Beach
country: United States
facility: WR- PRI, LLC ( Site 0044)
state: California
city: North Hollywood
country: United States
facility: Carbon Health - North Hollywood - NoHo West ( Site 0016)
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc. ( Site 0002)
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research ( Site 0023)
state: California
city: San Diego
country: United States
facility: WR-MCCR, LLC ( Site 0033)
state: California
city: San Diego
country: United States
facility: California Research Foundation ( Site 0005)
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc. ( Site 0020)
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0064)
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc ( Site 0029)
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute for Research, LLC ( Site 0013)
state: Florida
city: Jupiter
country: United States
facility: Health Awareness ( Site 0034)
state: Florida
city: Melbourne
country: United States
facility: Optimal Research ( Site 0008)
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research ( Site 0063)
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group-Clinical Department ( Site 0062)
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates ( Site 0041)
state: Florida
city: Miami
country: United States
facility: Alpha Science Research ( Site 0042)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A ( Site 0054)
state: Florida
city: Canton
country: United States
facility: East Coast Institute for Research - Canton ( Site 0004)
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta ( Site 0068)
state: Georgia
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc. ( Site 0072)
state: Illinois
city: Flossmoor
country: United States
facility: Healthcare Research Network - Chicago ( Site 0014)
state: Illinois
city: Elkridge
country: United States
facility: Centennial Medical Group ( Site 0035)
state: Maryland
city: Saint Louis
country: United States
facility: Healthcare Research Network - St. Louis ( Site 0011)
state: Missouri
city: Saint Louis
country: United States
facility: Radiant Research ( Site 0073)
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research-Primary Care ( Site 0066)
state: Nebraska
city: Las Vegas
country: United States
facility: WR-CRCN, LLC ( Site 0018)
state: Nevada
city: Santa Fe
country: United States
facility: Axces Research ( Site 0037)
state: New Mexico
city: Cortland
country: United States
facility: Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019)
state: New York
city: New York
country: United States
facility: Synexus Clinical Research US, Inc - New York ( Site 0053)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc. ( Site 0055)
state: New York
city: Vestal
country: United States
facility: Meridian Clinical Research, LLC ( Site 0032)
state: New York
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research ( Site 0047)
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research Associates ( Site 0040)
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center ( Site 0071)
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research, Medford ( Site 0060)
state: Oregon
city: Hatboro
country: United States
facility: Hatboro Medical Associates / CCT Research ( Site 0065)
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence ( Site 0021)
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson ( Site 0077)
state: South Carolina
city: Columbia
country: United States
facility: Velocity Clinical Research, Columbia ( Site 0058)
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group-Clinical Research ( Site 0028)
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group-Clinical Research ( Site 0009)
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc ( Site 0026)
state: Tennessee
city: Austin
country: United States
facility: Optimal Research ( Site 0015)
state: Texas
city: Brownsville
country: United States
facility: Headlands Research - Brownsville ( Site 0069)
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research ( Site 0025)
state: Texas
city: Houston
country: United States
facility: New Horizon Medical Group ( Site 0078)
state: Texas
city: Houston
country: United States
facility: Innovative Medical Research of Texas ( Site 0079)
state: Texas
city: Pearland
country: United States
facility: LinQ Research ( Site 0074)
state: Texas
city: Murray
country: United States
facility: Synexus Clinical Research US, Inc. ( Site 0001)
state: Utah
city: South Jordan
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0051)
state: Utah
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC ( Site 0059)
state: Washington
city: Spokane
country: United States
facility: Velocity Clinical Research, Spokane ( Site 0050)
state: Washington
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: