Clinical trial NCT05158140: Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Concomitant Administration of Either 23-Valent Pneumococcal Polysaccharide Vaccine or 15-Valent Pneumococcal Conjugate Vaccine With a Booster Dose of SARS-CoV-2 mRNA Vaccine in Healthy Adults 50 Years of Age or Older.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 850
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: The purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mRNA) mRNA-1273, the nucleoside-modified mRNA vaccine for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), with a 23-valent pneumococcal polysaccharide vaccine (V110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (V114) indicated for the prevention of invasive pneumococcal disease.


Eligibility criteria: Inclusion Criteria:

* Is in good health
* Any underlying chronic illness must be documented to be in stable condition
* Has received a 2-dose primary series of the Moderna mRNA SARS-CoV-2 vaccine ≥5 months before receipt of study vaccine at Visit 1
* May have received either: a) A first booster dose of the Moderna mRNA SARS-CoV-2 vaccine ≥4 months before receipt of study vaccine at Visit 1, or b) No booster dose of the Moderna mRNA SARS-CoV-2 vaccine
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using an acceptable contraceptive method, or is abstinent from heterosexual intercourse

Exclusion Criteria:

* Has a current SARS-CoV-2 infection or a known history of SARS-CoV-2 infection \<3 months before receipt of study vaccine at Visit 1
* Has a history of myocarditis and/or pericarditis
* 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 vaccinations
* Had a recent illness with fever (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\]; axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for an 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 receipt of study vaccine at Visit 1
* Received prior administration of a pneumococcal polysaccharide vaccine \<5 years before study enrollment or is expected to receive a pneumococcal polysaccharide vaccine during the study outside the protocol
* Received prior administration of a PCV \<1 year before receipt of study vaccine at Visit 1 or is expected to receive a PCV during the study outside the protocol
* Received prior administration of any SARS-CoV-2 vaccine other than the 2-dose primary series of the Moderna mRNA vaccine with or without a first booster dose, or is expected to receive any SARS-CoV-2 vaccine during the study outside the protocol
* Received prior monoclonal antibody treatment for SARS-CoV-2 infection
* Received antiviral treatment for SARS-CoV-2 infection \<3 months before receipt of study vaccine at Visit 1
* Received systemic corticosteroids for ≥14 consecutive days and has not completed intervention ≥30 days before receipt of study vaccine at Visit 1
* Received systemic corticosteroids exceeding physiologic replacement doses ≤14 days before receipt of study vaccine
* Is currently receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
* 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. Exception: Inactivated influenza vaccine allowed if given ≥7 days before or ≥15 days after receipt of study vaccine
* 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
* Received a blood transfusion or blood products (including globulin) ≤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
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study

Primary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110
timeFrame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
measure: Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114
timeFrame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
measure: Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110
timeFrame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
measure: Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114
timeFrame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
measure: Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110
timeFrame: Up to Month 6
measure: Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114
timeFrame: Up to Month 6
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110
timeFrame: Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: Serotype-specific OPA GMT in Participants Administered V114
timeFrame: Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114
timeFrame: Up to 30 days postvaccination with mRNA-1273 (Study Day 30)
Secondary outcomes:
measure: Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110
timeFrame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: Serotype-specific OPA GMFR in Participants Administered V114
timeFrame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114
timeFrame: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
measure: Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110
timeFrame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114
timeFrame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
measure: Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response
timeFrame: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
Other outcomes:
Locations:
city: North Hollywood
country: United States
facility: Carbon Health ( Site 0045)
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials Inc. ( Site 0002)
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC ( Site 0022)
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research ( Site 0024)
state: California
city: San Diego
country: United States
facility: California Research Foundation ( Site 0004)
state: California
city: Simi Valley
country: United States
facility: Millennium Clinical Trials ( Site 0027)
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc ( Site 0043)
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0036)
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Inc ( Site 0006)
state: Florida
city: Melbourne
country: United States
facility: Optimal Research LLC ( Site 0019)
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research LLC ( Site 0012)
state: Florida
city: Miami
country: United States
facility: Advanced Medical Research, LLC ( Site 0030)
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center For Medical Research ( Site 0053)
state: Georgia
city: Peoria
country: United States
facility: Optimal Research ( Site 0054)
state: Illinois
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0018)
state: Kansas
city: Lexington
country: United States
facility: AMR Lexington ( Site 0055)
state: Kentucky
city: Elkridge
country: United States
facility: Centennial Medical Group ( Site 0016)
state: Maryland
city: Marlborough
country: United States
facility: Community Clinical Research Center ( Site 0032)
state: Massachusetts
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0011)
state: Missouri
city: Las Vegas
country: United States
facility: Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)
state: Nevada
city: Santa Fe
country: United States
facility: AXCES Research Group ( Site 0017)
state: New Mexico
city: Cortland
country: United States
facility: Certified Research Associates ( Site 0042)
state: New York
city: Horseheads
country: United States
facility: Corning Center for Clinical Research ( Site 0052)
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc. ( Site 0010)
state: New York
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem ( Site 0049)
state: North Carolina
city: Cleveland
country: United States
facility: Velocity Clinical Research- Cleveland ( Site 0023)
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research-Providence ( Site 0015)
state: Rhode Island
city: North Charleston
country: United States
facility: Coastal Carolina Research Center ( Site 0044)
state: South Carolina
city: Austin
country: United States
facility: Benchmark Research ( Site 0007)
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research ( Site 0033)
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research ( Site 0039)
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston ( Site 0037)
state: Texas
city: Houston
country: United States
facility: Texas Center For Drug Development ( Site 0013)
state: Texas
city: McKinney
country: United States
facility: Wellness Clinical Research Associates ( Site 0051)
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group ( Site 0001)
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research ( Site 0025)
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research LLC ( Site 0020)
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0035)
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC ( Site 0008)
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc. ( Site 0014)
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC. ( Site 0005)
state: Virginia
city: Bayamon
country: Puerto Rico
facility: Cooperativa de Facultad Medica SANACOOP ( Site 0104)
city: Ponce
country: Puerto Rico
facility: CAIMED Center - Ponce School of Medicine ( Site 0103)
city: Rio Grande
country: Puerto Rico
facility: Caparra Internal Medicine Research Center. PSC ( Site 0102)
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico ( Site 0105)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: