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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: V110
* Biological: V114
* Biological: mRNA-1273
* Biological: Placebo for V110
* Biological: Placebo for V114


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V110 + concomitant mRNA-1273<br>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<br>* 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<br>* Other names: PNEUMOVAX™23;Biological: mRNA-1273<br>* Single IM dose of 50 μg/0.25 mL mRNA-1273<br>Biological: Placebo for V110<br>* Single IM dose of 0.5 mL placebo for V110<br>|
| Experimental: V110 + non-concomitant mRNA-1273<br>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<br>* 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<br>* Other names: PNEUMOVAX™23;Biological: mRNA-1273<br>* Single IM dose of 50 μg/0.25 mL mRNA-1273<br>Biological: Placebo for V110<br>* Single IM dose of 0.5 mL placebo for V110<br>|
| Experimental: V114 + concomitant mRNA-1273<br>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<br>* 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<br>* Other names: VAXNEUVANCE™;Biological: mRNA-1273<br>* Single IM dose of 50 μg/0.25 mL mRNA-1273<br>Biological: Placebo for V114<br>* Single IM dose of 0.5 mL placebo for V114<br>|
| Experimental: V114 + non-concomitant mRNA-1273<br>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<br>* 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<br>* Other names: VAXNEUVANCE™;Biological: mRNA-1273<br>* Single IM dose of 50 μg/0.25 mL mRNA-1273<br>Biological: Placebo for V114<br>* Single IM dose of 0.5 mL placebo for V114<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants with solicited injection-site adverse events (AEs) | Percentage of participants with solicited injection-site AEs | Up to Day 7 after any vaccination | 
| Participants with solicited systemic AEs | Percentage of participants with solicited systemic AEs | Up to Day 7 after any vaccination | 
| Participants with vaccine-related serious AEs (SAEs) | Percentage of participants with vaccine-related SAEs | Up to Month 6 | 
| Opsonophagocytic activity (OPA) Geometric mean titer (GMT) with V110 | Serotype-specific OPA GMT with V110 | Up to Day 60 | 
| OPA GMT with V114 | Serotype-specific OPA GMT with V114 | Up to Day 60 | 
| SARS-CoV-2-specific binding antibody (bAb) GMT | SARS-CoV-2-specific bAb GMT | Up to Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OPA geometric mean fold rise (GMFR) with V110 | Serotype-specific OPA GMFR with V110 | Baseline and up to Day 60 | 
| OPA GMFR with V114 | Serotype-specific OPA GMFR with V114 | Baseline and up to Day 60 | 
| Participants with a change from baseline in OPA with V110 | Percentage of participants with a ≥4-fold change from baseline in serotype-specific OPA with V110 | Baseline and up to Day 60 | 
| Participants with a change from baseline in OPA with V114 | Percentage of participants with a ≥4-fold change from baseline in serotype-specific OPA with V114 | Baseline and up to Day 60 | 
| SARS-CoV-2-specific bAb GMFR | SARS-CoV-2-specific bAb GMFR | Baseline and Day 30 | 
| Participants with a change from baseline in SARS-CoV-2-specific bAb GMFR | Percentage of participants with a ≥4-fold change from baseline in SARS-CoV-2-specific bAB GMFR | Baseline and Day 30 |