Clinical trials: sponsored by ModernaTX, Inc.
Healthy Participants
A Study to Investigate Safety and Tolerability of mRNA-0184 Administered Subcutaneously in Healthy Participants
The purpose of this study is to test the safety of mRNA-0184 in healthy participants.
- Trial name
- NCT06655870
- Testing
- mRNA-0184
- Where
- Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Melanoma
An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of…
- Trial name
- NCT03897881
- Testing
- mRNA-4157, Pembrolizumab
- Where
- 23 sites in United States, Australia
- Volunteers
- 267 people
- Sponsor
- ModernaTX, Inc.
Solid Tumors
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
The purpose of this study is to assess the safety, tolerability, and immunogenicity of mRNA-4157 alone and in combination in participants with solid tumors.
- Trial name
- KEYNOTE-603 (NCT03313778)
- Testing
- mRNA-4157, Pembrolizumab, SoC Treatment
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 161 people
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
- Trial name
- NCT06067230
- Testing
- mRNA-1345
- Where
- 44 sites in United States, Canada and 2 more
- Volunteers
- 1,153 people
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus (RSV), Human Metapneuomovirus (hMPV)
A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
- Trial name
- NCT07764237
- Testing
- mRNA-1365 (Profile 2), mRNA-1345 (Profile 1), mRNA-1345 (Profile 3)
- Where
- 10 sites in Canada, United Kingdom
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of…
- Trial name
- NCT06097299
- Testing
- mRNA-1345
- Where
- 50 sites in United States, Panama
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza
A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults
The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
- Trial name
- NCT07496450
- Testing
- mRNA-1018-H5
- Where
- 35 sites in United States, United Kingdom
- Volunteers
- 4,050 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Cytomegalovirus Infection
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV…
- Trial name
- NCT05683457
- Testing
- mRNA-1647
- Where
- 3 sites in United States
- Volunteers
- 84 people
- Sponsor
- ModernaTX, Inc.
Herpes Zoster
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age
The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
- Trial name
- NCT05701800
- Testing
- mRNA-1468, Shingrix
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Lyme Disease
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)
This clinical study will evaluate the safety, reactogenicity, and immunogenicity of monovalent mRNA-1982, a messenger ribonucleic acid (mRNA) vaccine to prevent Lyme disease in healthy adults aged 18 to 70 years old.
- Trial name
- NCT07561294
- Testing
- mRNA-1982
- Where
- 8 sites in Canada
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Lyme Disease
A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age
The purpose of this study is to evaluate the safety and immunogenicity in parallel of heptavalent mRNA-1975 and monovalent mRNA-1982 against Lyme disease in healthy adult participants.
- Trial name
- NCT05975099
- Testing
- mRNA-1975, mRNA-1982
- Where
- 20 sites in United States
- Volunteers
- 807 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Advanced Solid Tumors
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.
- Trial name
- NCT05533697
- Testing
- mRNA-4359, Pembrolizumab, Ipilimumab
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 361 people
- Sponsor
- ModernaTX, Inc.
Renal Cell Carcinoma
A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).
The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the…
- Trial name
- INTerpath-004 (NCT06307431)
- Testing
- Intismeran autogene, Pembrolizumab
- Where
- 63 sites in United States, Argentina and 12 more
- Volunteers
- 272 people
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19
A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations
The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
- Trial name
- NCT07089706
- Testing
- mRNA-1283.251 Variant-containing Formulation
- Where
- 5 sites in United States
- Volunteers
- 832 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus, Human Metapneumovirus
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in…
- Trial name
- NCT05743881
- Testing
- mRNA-1345, mRNA-1365, Nimenrix
- Where
- 17 sites in United States, Panama and 1 more
- Volunteers
- 186 people
- Sponsor
- ModernaTX, Inc.
Multiple Sclerosis
A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years
The primary objective of this trial is to evaluate the safety and reactogenicity of mRNA-1195 in participants with multiple sclerosis.
- Trial name
- NCT06735248
- Testing
- mRNA-1195
- Where
- 17 sites in United States, Australia and 1 more
- Volunteers
- 180 people
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born…
- Trial name
- NCT06143046
- Testing
- mRNA-1345
- Where
- 56 sites in United States, Canada and 6 more
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Cytomegalovirus
A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15…
- Trial name
- NCT05575492
- Testing
- mRNA-1647
- Where
- 57 sites in United States, Canada and 1 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Acute Gastroenteritis, Norovirus Acute Gastroenteritis
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE)…
- Trial name
- Nova 301 (NCT06592794)
- Testing
- mRNA-1403
- Where
- 283 sites in United States, Australia and 5 more
- Volunteers
- 37,864 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Genital Herpes
A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.
- Trial name
- NCT06033261
- Testing
- mRNA-1608, BEXSERO
- Where
- 23 sites in United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.