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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pneumococcal Infection

In brief

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.

Key facts

Study ID

NCT05158140

Run by

Merck Sharp & Dohme LLC

People needed

850

Starts

2022-01-12

Expected to finish

2023-02-21

Last updated by the study team

2025-07-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Carbon Health ( Site 0045) — North Hollywood, California, United States
• Valley Clinical Trials Inc. ( Site 0002) — Northridge, California, United States
• Center for Clinical Trials, LLC ( Site 0022) — Paramount, California, United States
• Artemis Institute for Clinical Research ( Site 0024) — San Diego, California, United States
• California Research Foundation ( Site 0004) — San Diego, California, United States
• Millennium Clinical Trials ( Site 0027) — Simi Valley, California, United States
• Diablo Clinical Research, Inc ( Site 0043) — Walnut Creek, California, United States
• Alliance for Multispecialty Research, LLC ( Site 0036) — Coral Gables, Florida, United States
• Indago Research and Health Center Inc ( Site 0006) — Hialeah, Florida, United States
• Optimal Research LLC ( Site 0019) — Melbourne, Florida, United States
• Advanced Medical Research, LLC ( Site 0030) — Miami, Florida, United States
• Lakes Research LLC ( Site 0012) — Miami Lakes, Florida, United States
• Atlanta Center For Medical Research ( Site 0053) — Atlanta, Georgia, United States
• Optimal Research ( Site 0054) — Peoria, Illinois, United States
• Alliance for Multispecialty Research, LLC ( Site 0018) — Newton, Kansas, United States
• AMR Lexington ( Site 0055) — Lexington, Kentucky, United States
• Centennial Medical Group ( Site 0016) — Elkridge, Maryland, United States
• Community Clinical Research Center ( Site 0032) — Marlborough, Massachusetts, United States
• Alliance for Multispecialty Research, LLC ( Site 0011) — Kansas City, Missouri, United States
• Wake Research Clinical Research Center of Nevada, LLC ( Site 0021) — Las Vegas, Nevada, United States
• AXCES Research Group ( Site 0017) — Santa Fe, New Mexico, United States
• Certified Research Associates ( Site 0042) — Cortland, New York, United States
• Corning Center for Clinical Research ( Site 0052) — Horseheads, New York, United States
• Rochester Clinical Research, Inc. ( Site 0010) — Rochester, New York, United States
• Accellacare - Winston-Salem ( Site 0049) — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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