Norovirus Acute GastroenteritisPhase 1/2NCT05992935
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
A Phase 1/2 study testing mRNA-1403 and mRNA-1405 in people with Norovirus Acute Gastroenteritis, run by ModernaTX, Inc. at 16 sites in 2 countries.
Trial summary
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Norovirus Acute Gastroenteritis
- What is being tested?
- mRNA-1403 and mRNA-1405
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,407 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 25 Aug 2023to 7 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A Phase 1: Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at the time of consent.
- Part B Phase 2 and Part C Phase 2: Adults 18 to 80 years of age at the time of consent.
- Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit.
- Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest/body feeding.
- A person of childbearing potential is using a highly effective contraceptive method.
- Participant has provided written informed consent for participation in this study.
Who cannot join
- Is acutely ill or febrile (temperature ≥38.0°C [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1.
- Part B Phase 2 booster extension period: acute disease or febrile 72 hours prior to or on Day 365.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Has a medical, psychiatric, or occupational condition, including reported history of substance abuse, which may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- Has a current or previous diagnosis of immunosuppressive condition, to include human immunodeficiency virus, or immune-mediated (autoimmune) disease that requires immunosuppressive therapies.
- (drugs or biologics). The use of topical corticosteroids or other immunosuppressive agents (for example, topical calcineurin inhibitor) may be eligible for participation at the discretion of the Investigator.
Show all 19Show fewer
- History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine or intervention that includes one or more of the same components contained in the study vaccine.
- Part A Phase 1 and Part B Phase 2 base period: Any history of myocarditis or pericarditis.
- Part B Phase 2 booster extension period and Part C Phase 2: Any history of myocarditis, pericarditis, or Guillain-Barré Syndrome.
- Coagulopathy or bleeding disorder considered a contraindication to IM injection or phlebotomy.
- Dermatologic conditions that could affect local solicited AR assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
- Has received systemic immunosuppressive therapies (drugs or biologics) for >14 days in total within 6 months prior to Screening or Day 365 (Part B Phase 2 booster extension period only) (for corticosteroids ≥10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, intra-articular, and topical steroids are allowed.
- Has received or plans to receive any licensed/authorized vaccine (to include severe acute respiratory syndrome-related coronavirus-2 vaccine) ≤28 days prior to or within 28 days after each study intervention, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study intervention.
- Has received systemic immunoglobulins or blood products within 3 months prior to Screening or Day 365 (Part B Phase 2 booster extension period only) or plans for receipt during the study.
- Has donated protocol-specified volume of blood products within protocol-specified timeframe.
- Participated or plans to participate in an interventional clinical study within protocol-specified timeframe.
- Part B Phase 2: Individuals who are participating/have participated in the Part A Phase 1 part of the study are excluded.
- Part A Phase 1: Any individual with laboratory abnormalities achieving thresholds defined in the protocol.
- Part C Phase 2: Individuals who have received an experimental NoV vaccine are excluded, including but not limited to individuals who are participating/have participated in Part A Phase 1 or Part B Phase 2 of the current study, or who are participating/have participated in mRNA-1403-P.301.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites
Accel Research Sites Network
Decatur, Georgia, 30030
Research Centers of America
Hollywood, Florida, 33024
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, 66219
ARK Clinical Research, LLC
Long Beach, California, 90815
Tekton Research, Inc - Longmont Center
Longmont, Colorado, 80501
Velocity Clinical Research - Boise
Meridian, Idaho, 83642
Velocity Clinical Research
Norfolk, Nebraska, 68701
Velocity Clinical Research
Omaha, Nebraska, 68134
Optimal Research
Peoria, Illinois, 61614
Epic Medical Research, LLC
Red Oak, Texas, 75154
Rochester Clinical Research, Inc
Rochester, New York, 14609
Velocity Clinical Research
Rockville, Maryland, 20854
JBR Clinical Research
Salt Lake City, Utah, 84107
Velocity Clinical Research
Sioux City, Iowa, 51106
Australia2 sites
Emeritus Research Camberwell
Camberwell
Nucleus Network
Melbourne
About this study
Official title: A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
- Conditions
- Norovirus Acute Gastroenteritis
- Being tested
- mRNA-1403, mRNA-1405, Placebo
- Keywords
- mRNA-1403, mRNA-1405, Norovirus, Viral Gastroenteritis, Acute Gastroenteritis, Norovirus Acute Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1403Biological
Sterile liquid for injection
mRNA-1405Biological
Sterile liquid for injection
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Part A: mRNA-1403 Dose Level 1 | Experimental | Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1. Receives: Biological: mRNA-1403 |
| Phase 1 Part A: mRNA-1403 Dose Level 2 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2. Receives: Biological: mRNA-1403 |
| Phase 1 Part A: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3. Receives: Biological: mRNA-1403 |
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4. Receives: Biological: mRNA-1403 |
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. Receives: Biological: mRNA-1403; Biological: Placebo |
| Phase 1 Part A: mRNA-1405 Dose Level 1 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1. Receives: Biological: mRNA-1405 |
| Phase 1 Part A: mRNA-1405 Dose Level 2 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2. Receives: Biological: mRNA-1405 |
| Phase 1 Part A: mRNA-1405 Dose Level 3 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3. Receives: Biological: mRNA-1405 |
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4. Receives: Biological: mRNA-1405 |
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2 | Experimental | Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. Receives: Biological: mRNA-1405; Biological: Placebo |
| Phase 1 Part A: Placebo | Placebo comparator | Participants will receive 2 IM injections of study vaccine-matching placebo. Receives: Biological: Placebo |
| Phase 2 Part B: mRNA-1403 Dose Level 1 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1. Receives: Biological: mRNA-1403 |
| Phase 2 Part B: mRNA-1403 Dose Level 2 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of study vaccine-matching placebo 12-15 months after first dose. Receives: Biological: mRNA-1403; Biological: Placebo |
| Phase 2 Part B: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 12-15 months after first dose. Receives: Biological: mRNA-1403; Biological: Placebo |
| Phase 2 Part B: Placebo | Placebo comparator | Participants will receive 1 IM injection of study vaccine-matching placebo. Receives: Biological: Placebo |
| Phase 2 Part C: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3. Receives: Biological: mRNA-1403 |
| Phase 2 Part C: Placebo | Placebo comparator | Participants will receive 1 IM injection of study vaccine-matching placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Measured: Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
Measured: Day 1 up to a maximum of Day 546
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study, and Adverse Events of Special Interest (AESIs)
Measured: Day 1 up to a maximum of Day 730
Secondary outcomes (6)
Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Measured: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 169, 365, and 393
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers
Measured: Phase 1: Days 29, and 57; Phase 2: Days 29, 169, 365, and 393
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers
Measured: Phase 1: Days 29, and 57; Phase 2: Days 29, 169, and 393
Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Measured: Days 1, 29, and 57
GMFR of bAb Levels
Measured: Days 29 and 57
Percentage of Participants with Seroresponse Based on bAb Levels
Measured: Days 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start25 Aug 2023
- Primary completion7 Oct 2026
- Study completion7 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Norovirus Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992935
- Sponsor's protocol ID
- mRNA-1403/1405-P101
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
- ClinicalTrials.gov ID
- NCT05992935
- Acronym / sponsor ID
- mRNA-1403/1405-P101
- Conditions
- Norovirus Acute Gastroenteritis
- Keywords
- mRNA-1403, mRNA-1405, Norovirus, Viral Gastroenteritis, Acute Gastroenteritis, Norovirus Acute Gastroenteritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,407 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 7 Oct 2026 (actual)
- Study completion
- 7 Oct 2026 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Part A: mRNA-1403 Dose Level 1 | Experimental | Biological: mRNA-1403Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1. |
| Phase 1 Part A: mRNA-1403 Dose Level 2 | Experimental | Biological: mRNA-1403Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2. |
| Phase 1 Part A: mRNA-1403 Dose Level 3 | Experimental | Biological: mRNA-1403Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3. |
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1 | Experimental | Biological: mRNA-1403Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4. |
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2 | Experimental | Biological: mRNA-1403, Biological: PlaceboParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. |
| Phase 1 Part A: mRNA-1405 Dose Level 1 | Experimental | Biological: mRNA-1405Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1. |
| Phase 1 Part A: mRNA-1405 Dose Level 2 | Experimental | Biological: mRNA-1405Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2. |
| Phase 1 Part A: mRNA-1405 Dose Level 3 | Experimental | Biological: mRNA-1405Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3. |
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1 | Experimental | Biological: mRNA-1405Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4. |
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2 | Experimental | Biological: mRNA-1405, Biological: PlaceboParticipants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. |
| Phase 1 Part A: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive 2 IM injections of study vaccine-matching placebo. |
| Phase 2 Part B: mRNA-1403 Dose Level 1 | Experimental | Biological: mRNA-1403Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1. |
| Phase 2 Part B: mRNA-1403 Dose Level 2 | Experimental | Biological: mRNA-1403, Biological: PlaceboParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of study vaccine-matching placebo 12-15 months after first dose. |
| Phase 2 Part B: mRNA-1403 Dose Level 3 | Experimental | Biological: mRNA-1403, Biological: PlaceboParticipants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 12-15 months after first dose. |
| Phase 2 Part B: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive 1 IM injection of study vaccine-matching placebo. |
| Phase 2 Part C: mRNA-1403 Dose Level 3 | Experimental | Biological: mRNA-1403Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3. |
| Phase 2 Part C: Placebo | Placebo comparator | Biological: PlaceboParticipants will receive 1 IM injection of study vaccine-matching placebo. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Part A Phase 1: Adults 18 to 49 years of age at the time of consent or adults 60 to 80 years of age at the time of consent.
- Part B Phase 2 and Part C Phase 2: Adults 18 to 80 years of age at the time of consent.
- Body mass index of 18 to 39 kilogram/meter^2 (inclusive) at the Screening Visit.
- Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest/body feeding.
- A person of childbearing potential is using a highly effective contraceptive method.
Key exclusion criteria (19 listed)
- Is acutely ill or febrile (temperature ≥38.0°C [100.4°F]) 72 hours prior to or at the Screening Visit or Day 1.
- Part B Phase 2 booster extension period: acute disease or febrile 72 hours prior to or on Day 365.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Has a medical, psychiatric, or occupational condition, including reported history of substance abuse, which may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the Investigator's judgment.
- Has a current or previous diagnosis of immunosuppressive condition, to include human immunodeficiency virus, or immune-mediated (autoimmune) disease that requires immunosuppressive therapies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1403Sterile liquid for injection | Biological | Phase 1 Part A: mRNA-1403 Dose Level 1, Phase 1 Part A: mRNA-1403 Dose Level 2, Phase 1 Part A: mRNA-1403 Dose Level 3, Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1, Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2, Phase 2 Part B: mRNA-1403 Dose Level 1, Phase 2 Part B: mRNA-1403 Dose Level 2, Phase 2 Part B: mRNA-1403 Dose Level 3, Phase 2 Part C: mRNA-1403 Dose Level 3 |
| mRNA-1405Sterile liquid for injection | Biological | Phase 1 Part A: mRNA-1405 Dose Level 1, Phase 1 Part A: mRNA-1405 Dose Level 2, Phase 1 Part A: mRNA-1405 Dose Level 3, Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1, Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2 |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | Phase 1 Part A: Placebo, Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2, Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2, Phase 2 Part B: Placebo, Phase 2 Part B: mRNA-1403 Dose Level 2, Phase 2 Part B: mRNA-1403 Dose Level 3, Phase 2 Part C: Placebo |
Primary outcome
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
Time frame: Day 1 up to a maximum of Day 546
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study, and Adverse Events of Special Interest (AESIs)
Time frame: Day 1 up to a maximum of Day 730
6 secondary outcomes
Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Time frame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 169, 365, and 393
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers
Time frame: Phase 1: Days 29, and 57; Phase 2: Days 29, 169, 365, and 393
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers
Time frame: Phase 1: Days 29, and 57; Phase 2: Days 29, 169, and 393
Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Time frame: Days 1, 29, and 57
GMFR of bAb Levels
Time frame: Days 29 and 57
Percentage of Participants with Seroresponse Based on bAb Levels
Time frame: Days 29 and 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mRNA-1403 and mRNA-1405 in people with Norovirus Acute Gastroenteritis, run by ModernaTX, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to a maximum of Day 36 (7 days after each study injection)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.