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Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05158140
Collaborator
(none)
1,300
Enrollment
46
Locations
4
Arms
17.9
Anticipated Duration (Months)
28.3
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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 for the prevention of pneumococcal disease (V110) and, a 15-valent pneumococcal conjugate vaccine (PCV) indicated for the prevention of invasive pneumococcal disease (V114).

Condition or Disease Intervention/Treatment Phase
  • Biological: V110
  • Biological: V114
  • Biological: mRNA-1273
  • Biological: Placebo for V110
  • Biological: Placebo for V114
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Jul 11, 2023
Anticipated Study Completion Date :
Jul 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: V110 + concomitant mRNA-1273

Single dose vaccination of V110 concomitantly with a single dose vaccination of mRNA-1273 on Day 1, followed by a single dose vaccination of placebo for V110 on Day 30

Biological: V110
Single intramuscular (IM) dose of 0.5 mL V110 a pneumococcal polysaccharide vaccine containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
Other Names:
  • PNEUMOVAX™23

    • Biological: mRNA-1273
    Single IM dose of 50 μg/0.5 mL mRNA-1273

    Biological: Placebo for V110
    Single IM dose of 0.5 mL placebo for V110
    Experimental: V110 + non-concomitant mRNA-1273

    Single dose vaccination of placebo for V110 on Day 1 concomitantly with a single dose vaccination of mRNA-1273, followed by a single dose vaccination of V110 on Day 30

    Biological: V110
    Single intramuscular (IM) dose of 0.5 mL V110 a pneumococcal polysaccharide vaccine containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
    Other Names:
  • PNEUMOVAX™23

    • Biological: mRNA-1273
    Single IM dose of 50 μg/0.5 mL mRNA-1273

    Biological: Placebo for V110
    Single IM dose of 0.5 mL placebo for V110
    Experimental: V114 + concomitant mRNA-1273

    Single dose vaccination of V114 concomitantly with a single dose vaccination of mRNA-1273 on Day 1, followed by a single dose vaccination of placebo for V114 on Day 30

    Biological: V114
    Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
    Other Names:
  • VAXNEUVANCE™

    • Biological: mRNA-1273
    Single IM dose of 50 μg/0.5 mL mRNA-1273

    Biological: Placebo for V114
    Single IM dose of 0.5 mL placebo for V114
    Experimental: V114 + non-concomitant mRNA-1273

    Single dose vaccination of placebo for V114 on Day 1 concomitantly with a single dose vaccination of mRNA-1273, followed by a single dose vaccination of V114 on Day 30

    Biological: V114
    Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
    Other Names:
  • VAXNEUVANCE™

    • Biological: mRNA-1273
    Single IM dose of 50 μg/0.5 mL mRNA-1273

    Biological: Placebo for V114
    Single IM dose of 0.5 mL placebo for V114

    Outcome Measures

    Primary Outcome Measures

    1. Participants with solicited injection-site adverse events (AEs) [Up to Day 7 after any vaccination]

      Percentage of participants with solicited injection-site AEs

    2. Participants with solicited systemic AEs [Up to Day 7 after any vaccination]

      Percentage of participants with solicited systemic AEs

    3. Participants with vaccine-related serious AEs (SAEs) [Up to Month 6]

      Percentage of participants with vaccine-related SAEs

    4. Opsonophagocytic activity (OPA) Geometric mean titer (GMT) with V110 [Up to Day 60]

      Serotype-specific OPA GMT with V110

    5. OPA GMT with V114 [Up to Day 60]

      Serotype-specific OPA GMT with V114

    6. SARS-CoV-2-specific binding antibody (bAb) GMT [Up to Day 30]

      SARS-CoV-2-specific bAb GMT

    Secondary Outcome Measures

    1. OPA geometric mean fold rise (GMFR) with V110 [Baseline and up to Day 60]

      Serotype-specific OPA GMFR with V110

    2. OPA GMFR with V114 [Baseline and up to Day 60]

      Serotype-specific OPA GMFR with V114

    3. Participants with a change from baseline in OPA with V110 [Baseline and up to Day 60]

      Percentage of participants with a ≥4-fold change from baseline in serotype-specific OPA with V110

    4. Participants with a change from baseline in OPA with V114 [Baseline and up to Day 60]

      Percentage of participants with a ≥4-fold change from baseline in serotype-specific OPA with V114

    5. SARS-CoV-2-specific bAb GMFR [Baseline and Day 30]

      SARS-CoV-2-specific bAb GMFR

    6. Participants with a change from baseline in SARS-CoV-2-specific bAb GMFR [Baseline and Day 30]

      Percentage of participants with a ≥4-fold change from baseline in SARS-CoV-2-specific bAB GMFR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Carbon Health ( Site 0045) North Hollywood California United States 91606
    2 Valley Clinical Trials Inc. ( Site 0002) Northridge California United States 91325
    3 Center for Clinical Trials, LLC ( Site 0022) Paramount California United States 90723
    4 Artemis Institute for Clinical Research ( Site 0024) San Diego California United States 92103
    5 California Research Foundation ( Site 0004) San Diego California United States 92123
    6 Millennium Clinical Trials ( Site 0027) Simi Valley California United States 93065
    7 Diablo Clinical Research, Inc ( Site 0043) Walnut Creek California United States 94598
    8 Alliance for Multispecialty Research, LLC ( Site 0036) Coral Gables Florida United States 33134
    9 Indago Research and Health Center Inc ( Site 0006) Hialeah Florida United States 33012
    10 Optimal Research LLC ( Site 0019) Melbourne Florida United States 32934
    11 Lakes Research LLC ( Site 0012) Miami Lakes Florida United States 33014
    12 Advanced Medical Research, LLC ( Site 0030) Miami Florida United States 33174
    13 Atlanta Center For Medical Research ( Site 0053) Atlanta Georgia United States 30331
    14 Optimal Research ( Site 0054) Peoria Illinois United States 61614
    15 Alliance for Multispecialty Research, LLC ( Site 0018) Newton Kansas United States 67114
    16 AMR Lexington ( Site 0055) Lexington Kentucky United States 40509
    17 Centennial Medical Group ( Site 0016) Elkridge Maryland United States 21075
    18 Community Clinical Research Center ( Site 0032) Marlborough Massachusetts United States 01752
    19 Alliance for Multispecialty Research, LLC ( Site 0011) Kansas City Missouri United States 64114
    20 Wake Research Clinical Research Center of Nevada, LLC ( Site 0021) Las Vegas Nevada United States 89106
    21 AXCES Research Group ( Site 0017) Santa Fe New Mexico United States 87505
    22 Certified Research Associates ( Site 0042) Cortland New York United States 13045
    23 Corning Center for Clinical Research ( Site 0052) Horseheads New York United States 14845
    24 Rochester Clinical Research, Inc. ( Site 0010) Rochester New York United States 14609
    25 Accellacare - Winston-Salem ( Site 0049) Winston-Salem North Carolina United States 27103
    26 Velocity Clinical Research- Cleveland ( Site 0023) Cleveland Ohio United States 44122
    27 Velocity Clinical Research-Providence ( Site 0015) East Greenwich Rhode Island United States 02818
    28 Coastal Carolina Research Center ( Site 0044) North Charleston South Carolina United States 29405
    29 Benchmark Research ( Site 0007) Austin Texas United States 78705
    30 South Texas Clinical Research ( Site 0033) Corpus Christi Texas United States 78413
    31 Benchmark Research ( Site 0039) Fort Worth Texas United States 76135
    32 University of Texas Medical Branch at Galveston ( Site 0037) Galveston Texas United States 77555-1115
    33 Texas Center For Drug Development ( Site 0013) Houston Texas United States 77081
    34 Wellness Clinical Research Associates ( Site 0051) McKinney Texas United States 75071
    35 Diagnostics Research Group ( Site 0001) San Antonio Texas United States 78229
    36 DM Clinical Research ( Site 0025) Tomball Texas United States 77375
    37 Crossroads Clinical Research LLC ( Site 0020) Victoria Texas United States 77901
    38 Velocity Clinical Research, Salt Lake City ( Site 0035) West Jordan Utah United States 84088
    39 Charlottesville Medical Research Center, LLC ( Site 0008) Charlottesville Virginia United States 22911
    40 Health Research of Hampton Roads, Inc. ( Site 0014) Newport News Virginia United States 23606
    41 Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057) Norfolk Virginia United States 23502
    42 Clinical Research Partners, LLC. ( Site 0005) Richmond Virginia United States 23226
    43 Cooperativa de Facultad Medica SANACOOP ( Site 0104) Bayamon Puerto Rico 00961
    44 CAIMED Center - Ponce School of Medicine ( Site 0103) Ponce Puerto Rico 00716
    45 Caparra Internal Medicine Research Center. PSC ( Site 0102) Rio Grande Puerto Rico 00745
    46 Clinical Research Puerto Rico ( Site 0105) San Juan Puerto Rico 00909

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT05158140
    Other Study ID Numbers:
    • V110-911
    • V110-911
    • 2021-003414-39
    First Posted:
    Dec 15, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pneumococcal Infections
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    No Results Posted as of Aug 12, 2022