Phase 3
N=850
Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
Pneumococcal Infection
Bottom Line
View on ClinicalTrials.gov: NCT05158140 ↗Enrolled (actual)
850
Serious AEs
1.7%
Results posted
Feb 2024
Primary outcome: Primary: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 — 18.7; 14.7; 74.8; 74.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V110 (Biological); V114 (Biological); mRNA-1273 (Biological); Placebo for V110 (Biological); Placebo for V114 (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 |
18.7; 14.7; 74.8; 74.4; 23.4; 26.5 | — |
| PRIMARY Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 |
15.3; 16.3; 70.8; 76.9; 20.6; 29.3 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 |
15.4; 17.5; 18.7; 17.5; 40.7; 36.5 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 |
16.7; 18.8; 18.7; 18.8; 41.1; 46.6 | — |
| PRIMARY Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110 |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114 |
0.0; 0.0 | — |
| PRIMARY Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 |
236.0; 235.5; 174.3; 284.0; 1384.5; 1704.4 | — |
| PRIMARY Serotype-specific OPA GMT in Participants Administered V114 |
208.3; 265.6; 237.5; 338.4; 1586.0; 1758.6 | — |
| PRIMARY SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 |
824118.4; 861746.4; 1102295.7 | — |
| SECONDARY Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 |
24.8; 24.2; 7.1; 11.6; 12.8; 15.7 | — |
| SECONDARY Serotype-specific OPA GMFR in Participants Administered V114 |
17.3; 24.5; 9.0; 14.5; 13.3; 20.6 | — |
| SECONDARY SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 |
8.6; 8.1; 9.1 | — |
| SECONDARY Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 |
76.0; 75.1; 66.9; 72.5; 66.3; 68.2 | — |
| SECONDARY Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 |
72.7; 73.4; 65.2; 79.3; 68.9; 73.2 | — |
| SECONDARY Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response |
55.1; 52.3; 55.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT05158140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.