Clinical trials: sponsored by ModernaTX, Inc.
Seasonal Influenza
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to <18 years of age).
- Trial name
- NCT07870330
- Testing
- mRNA-1010, Fluarix Trivalent
- Where
- 6 sites in United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
- Trial name
- NCT07863635
- Testing
- mRNA-1273, mRNA-1283
- Where
- 5 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
This study will evaluate 2 dose levels of mRNA-1283 in participants ≥6 months to <12 years to determine the optimal dose level per age group.
- Trial name
- NCT07808697
- Testing
- mRNA-1283, mRNA-1273
- Where
- 31 sites in United States, Argentina and 4 more
- Volunteers
- 300 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.
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.
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.
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.
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.
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.
Propionic Acidemia
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).
- Trial name
- NCT05130437
- Testing
- mRNA-3927
- Where
- 22 sites in United States, Canada and 6 more
- Volunteers
- 50 people
- Sponsor
- ModernaTX, Inc.
Propionic Acidemia
A Retrospective Study to Characterize Participants With Propionic Acidemia
This is a non-interventional, observational, global, multicenter, study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).
- Trial name
- NCT05769621
- Where
- 29 sites in United States, Australia and 7 more
- Volunteers
- 60 people
- Sponsor
- ModernaTX, Inc.
Healthy Volunteers
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
The primary objective of this study is to assess cardiac troponin I (cTnI) values in participants who received mRNA-1273.712 or placebo.
- Trial name
- NCT06634797
- Testing
- mRNA-1273.712
- Where
- 24 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Propionic Acidemia
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
This 3-part, Phase 1/2 study is designed to characterize the safety, tolerability, and pharmacological activity (as assessed by biomarker measurements) and to determine the selected dose of mRNA-3927 in participants with…
- Trial name
- NCT04159103
- Testing
- mRNA-3927
- Where
- 35 sites in United States, Canada and 6 more
- Volunteers
- 77 people
- Sponsor
- ModernaTX, Inc.
Methylmalonic Acidemia
An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705
The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT)…
- Trial name
- NCT05295433
- Testing
- mRNA-3705
- Where
- 12 sites in United States, Canada and 4 more
- Volunteers
- 56 people
- Sponsor
- ModernaTX, Inc.
Cytomegalovirus Infection
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants.
- Trial name
- NCT05085366
- Testing
- mRNA-1647
- Where
- 296 sites in United States, Australia and 11 more
- Volunteers
- 7,454 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.