Clinical trials: sponsored by 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.
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.
Epstein-Barr Virus Infection
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in…
- Trial name
- NCT05164094
- Testing
- mRNA-1189
- Where
- 65 sites in United States
- Volunteers
- 867 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Methylmalonic Acidemia
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia
This is a study of mRNA-3705 in participants with isolated elevated methylmalonic acid (MMA) due to methylmalonyl-coenzyme A (CoA) mutase (MUT) deficiency.
- Trial name
- NCT04899310
- Testing
- mRNA-3705
- Where
- 11 sites in United States, Canada and 4 more
- Volunteers
- 18 people
- Sponsor
- ModernaTX, Inc.
Cytomegalovirus Infection
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
- Trial name
- NCT04232280
- Testing
- mRNA-1647
- Where
- 9 sites in United States
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Respiratory Syncytial Virus
A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age
The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically…
- Trial name
- NCT07117487
- Testing
- mRNA-1345
- Where
- 11 sites in United States
- Volunteers
- 507 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
COVID-19
A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815…
- Trial name
- NextCOVE (NCT05815498)
- Testing
- mRNA-1283.222, mRNA-1273.222, mRNA-1283.815
- Where
- 230 sites in United States, Canada and 2 more
- Volunteers
- 13,553 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
Post-marketing Surveillance (PMS) Use-Result Surveillance With SPIKEVAX BIVALENT, SPIKEVAX X Injection, SPIKEVAX JN Injection and SPIKEVAX IN PRE-FILLED SYRINGE
The main objective of the surveillance is to evaluate the incidence of the adverse events (AEs), and other safety-related information in South-Korean population.
- Trial name
- NCT06333704
- Testing
- SPIKEVAX Bivalent BA.1, SPIKEVAX Bivalent BA.4/5, SPIKEVAX XBB.1.5
- Where
- 26 sites in South Korea
- Volunteers
- 4,207 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory…
- Trial name
- NCT06585241
- Testing
- mRNA-1273 Variant-containing Formulation
- Where
- 6 sites in United States
- Volunteers
- 1,144 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Epstein-Barr Virus
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
- Trial name
- NCT07478952
- Testing
- mRNA-1189
- Where
- 2 sites in Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.