Respiratory Syncytial VirusPhase 1NCT04528719
A Dose Escalation Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1345 in Healthy Adults and in Children Who Are Respiratory Syncytial Virus (RSV)-Seropositive
A Phase 1 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 31 sites in United States.
Trial summary
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days… Read more about this study
- Who is it for?
- Ages 12 months to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- mRNA-1345
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 651 participants
- Where
- 31 sitesUnited States
- Study dates
- 30 Sep 2020to 18 Jul 2024
- Phase
- Phase 1
- 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 12 months to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy young adults ≥18 to ≤49 years of age, women of child-bearing potential ≥18 to ≤40 years of age, healthy older adults ≥65 to <80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to < 60 months of age.
- Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.
- Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):
- Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)^2 to ≤35 kg/m^2.
- Female participants of non-child-bearing potential. This criterion does not apply for women of child-bearing potential Cohorts 12, 13, and 14.
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- Female participants of child-bearing potential may be enrolled in the study, if the participant: 1) has a negative urine pregnancy test at Screening and on the day of vaccination; 2) has practiced adequate contraception or has abstained from all activities that could lead to pregnancy for 28 days prior to vaccination; 3) has agreed to continue adequate contraception through 3 months following the last injection; and 4) is not currently breastfeeding.
- Specific inclusion criteria for children 12 to 59 months of age:
- Seropositive for RSV-neutralizing Abs at Screening.
- Has received routine immunizations appropriate for age per local guidance.
- Current height and weight above the third percentile for age.
- Specific inclusion criteria for Japanese older adults:
- Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
Who cannot join
- Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
- Is acutely ill or febrile on the day of the first injection.
- Has a significant medical history, including but not limited to:
- Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection.
- Chronic hepatitis or suspected active hepatitis.
- Bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
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- Dermatologic conditions that could affect local solicited AR assessments.
- Any history of allergic or anaphylactic reactions following a vaccination that required medical intervention.
- Autoimmune disease except for Hashimoto's disease.
- Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrollment. Inhaled, nasal, and topical steroids are allowed.
- Intravenous blood products (red cells, platelets, and immunoglobulins [Ig]) within 3 months prior to enrollment.
- Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Nonstudy vaccinations should not be delayed.
- Has a history of myocarditis, pericarditis, or myopericarditis.
- Specific exclusion criteria for older adults (Cohorts 7-11 and 15):
- Known history of poorly controlled hypertension (per determination of the Investigator) or systolic blood pressure >160 millimeters of mercury (mmHg) at the Screening visit.
- Known history of hypotension or systolic blood pressure <85 mmHg at the Screening visit.
- Poorly controlled diabetes mellitus (per determination of the Investigator).
- Diagnosis of significant chronic pulmonary disease (per determination of the Investigator) (such as, chronic obstructive pulmonary disease, asthma).
- Significant chronic cardiovascular disease (per determination of the Investigator).
- Resides in a nursing home.
- Anticipates the need for immunosuppressive treatment at any time during participation in the study.
- Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer and cervical carcinoma in-situ).
- Specific exclusion criteria for children 12 to 59 months of age (Cohorts 5 and 6):
- Has received any monoclonal antibody at any time prior to Screening.
- Prior hospitalization for RSV disease in the last 2 years.
- Receipt of any prior systemic immunosuppressants or immune-modifying drugs.
- Any history of febrile seizures (inclusive of single simple febrile seizure).
- History of epilepsy.
- History of meningitis.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Velocity Clinical Research (Albuquerque - New Mexico) - PPDS
Albuquerque, New Mexico, 87102-3876
Velocity Clinical Research (Binghamton - New York) - PPDS
Binghamton, New York, 13901-1046
Velocity Clinical Research - Columbia - PPDS
Columbia, South Carolina, 29204
Centricity Research - Roswell - HyperCore - PPDS
Columbus, Georgia, 31904-8946
IResearch Atlanta LLC
Decatur, Georgia, 30030-3438
Accel Research Site - Angel Kids Pediatrics - ERN - PPDS
DeLand, Florida, 32720-0834
Henry Ford Health System
Detroit, Michigan, 48202
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska, 68803
Velocity Clinical Research (Greenville - South Carolina) - PPDS
Greenville, South Carolina, 29615-4833
Velocity Clinical Research (Hastings - Nebraska) - PPDS
Hastings, Nebraska, 68901
East-West Medical Research Institute
Honolulu, Hawaii, 96814-4526
Cyfair Clinical Research Center - ERN - PPDS
Houston, Texas, 77065
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114-4866
Paradigm Clinical Research Institute Inc - ClinEdge - PPDS
La Mesa, California, 91942-3189
Velocity Clinical Research (Lafayette - Louisiana) - PPDS
Lafayette, Louisiana, 70508-5173
Tanner Clinic
Layton, Utah, 84041
Velocity Clinical Research - Medford - ERN - PPDS
Medford, Oregon, 97504-9741
Velocity Clinical Research (Metaire - Louisiana) - PPDS
Metairie, Louisiana, 70006
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, 40517
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska, 68701
Velocity Clinical Research (Omaha - Nebraska) - PPDS
Omaha, Nebraska, 68134
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
Orlando, Florida, 32806-2908
Synexus - Optimal Research - Peoria
Peoria, Illinois, 61614
Clinical Research Partners LLC
Richmond, Virginia, 23226-3787
Flourish Research - San Antonio - PPDS
San Antonio, Texas, 78229-3539
Velocity Clinical Research (Savannah - Georgia) - PPDS
Savannah, Georgia, 31406-2675
Velocity Clinical Research (Sioux City - Iowa) - PPDS
Sioux City, Iowa, 51106-4233
Velocity Clinical Research (Slidell - Louisiana) - PPDS
Slidell, Louisiana, 70458-5334
DM Clinical Research
Tomball, Texas, 77375-6543
Mills Clinical Research
West Hollywood, California, 90046
Palm Beach Research - ClinEdge - PPDS
West Palm Beach, Florida, 33409-3401
About this study
Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
The primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- mRNA-1345, Placebo
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Safety, Pediatric, Vaccines
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1345Biological
Formulation for injection
PlaceboDrug
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose A in Younger Adults | Experimental | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 2: Dose B in Younger Adults | Experimental | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 3: Dose B in Younger Adults | Experimental | Three total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 4: Dose C in Younger Adults | Experimental | Single injection of Dose C of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 5: Dose D in Children | Experimental | Three total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 6: Dose G in Children | Experimental | Three total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 7: Dose A in Older Adults | Experimental | Two total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 8: Dose B in Older Adults | Experimental | Two total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 9: Dose C in Older Adults | Experimental | Two total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 10: Dose E in Older Adults | Experimental | Two total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 11: Dose F in Older Adults | Experimental | Two total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 12: Dose E in Women of Child-Bearing Potential | Experimental | Single injection of Dose E of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 13: Dose F in Women of Child-Bearing Potential | Experimental | Single injection of Dose F of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 14: Dose A in Women of Child-Bearing Potential | Experimental | Single injection of Dose A of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: Placebo |
| Cohort 15: Dose B in Japanese Older Adults | Experimental | Single injection of Dose B of mRNA-1345 or matching-placebo on Day 1. Receives: Biological: mRNA-1345; Drug: 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 Adverse Reactions (ARs)
Measured: Up to Day 737 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 758 (28 days after the last injection)
Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)
Measured: Up to Day 1095 (End of Study)
Secondary outcomes (3)
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
Measured: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Measured: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline
Measured: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start30 Sep 2020
- Primary completion18 Jul 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 651 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
- NCT04528719
- Sponsor's protocol ID
- mRNA-1345-P101
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schnyder Ghamloush S, Fanning S, Essink B, Eder F, Snape MD, Stoszek SK, Guo R, Dhar R, Righi V, Morsy L, Kapoor A, El Asmar L, Shaw CA. Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. Hum Vaccin Immunother. 2025 Dec;21(1):2557676. doi: 10.1080/21645515.2025.2557676. Epub 2025 Sep 15.
PubMed 40953212Fitz-Patrick D, Mihara H, Mills A, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Simorellis AK, Panozzo CA, Reuter C, Wilson E, Chen GL, Stoszek SK, Shaw CA, Goswami J. Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged >/=60 years: A phase 1, randomized, observer-blind, placebo-controlled trial. Respir Investig. 2024 Nov;62(6):1037-1043. doi: 10.1016/j.resinv.2024.08.011. Epub 2024 Sep 9.
PubMed 39255587Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
PubMed 38385566Shaw CA, Mithani R, Kapoor A, Dhar R, Wilson L, El Asmar L, Schnyder-Ghamloush S, Schaefers K, August A, Stoszek SK, Chen GL. Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e637-e646. doi: 10.1093/infdis/jiae035.
PubMed 38298125
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months
- ClinicalTrials.gov ID
- NCT04528719
- Acronym / sponsor ID
- mRNA-1345-P101
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, RSV Seropositive, Safety, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 651 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 27 Aug 2020 (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 primary objectives of this study are to evaluate the tolerability and reactogenicity of a single injection of up to 5 dose levels of mRNA-1345 in younger adults, women of child-bearing potential, and older adults including Japanese older adults; of 3 injections of the middle dose level of mRNA-1345 given 56 days apart in younger adults; of a booster injection of mRNA-1345 given approximately 12 and 24 months after the primary injection in older adults; and of 3 injections of 1 of 2 dose levels of mRNA-1345 given 56 days apart in children who are RSV-seropositive.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose A in Younger Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 2: Dose B in Younger Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 3: Dose B in Younger Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboThree total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 4: Dose C in Younger Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose C of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 5: Dose D in Children | Experimental | Biological: mRNA-1345, Drug: PlaceboThree total injections, 1 injection of either Dose D of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 6: Dose G in Children | Experimental | Biological: mRNA-1345, Drug: PlaceboThree total injections, 1 injection of either Dose G of mRNA-1345 or matching-placebo per day on Day 1, Day 57, and Day 113. |
| Cohort 7: Dose A in Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboTwo total injections, 1 injection of either Dose A of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 8: Dose B in Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboTwo total injections, 1 injection of either Dose B of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 9: Dose C in Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboTwo total injections, 1 injection of either Dose C of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 10: Dose E in Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboTwo total injections, 1 injection of either Dose E of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 11: Dose F in Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboTwo total injections, 1 injection of either Dose F of mRNA-1345 or matching-placebo per day on Day 1 and approximately 12 months later. Participants will receive second booster injection of Dose A of mRNA-1345 at Month 24. |
| Cohort 12: Dose E in Women of Child-Bearing Potential | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose E of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 13: Dose F in Women of Child-Bearing Potential | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose F of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 14: Dose A in Women of Child-Bearing Potential | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose A of mRNA-1345 or matching-placebo on Day 1. |
| Cohort 15: Dose B in Japanese Older Adults | Experimental | Biological: mRNA-1345, Drug: PlaceboSingle injection of Dose B of mRNA-1345 or matching-placebo on Day 1. |
Who may qualify
- Ages
- 12 months to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy young adults ≥18 to ≤49 years of age, women of child-bearing potential ≥18 to ≤40 years of age, healthy older adults ≥65 to <80 years of age, Japanese older adults ≥ 60 years of age, and children ≥12 to < 60 months of age.
- Willing and physically able to comply with protocol-mandated follow-up, including all procedures.
- Adult participant or parent(s)/legal guardian(s) of pediatric participants has provided written informed consent for participation in this study, including all evaluations and procedures as specified by the protocol.
- Specific inclusion criteria for adults (younger adults, women of child-bearing potential, and older adults [including Japanese older adults]):
- Has a body mass index (BMI) from ≥18 kilogram (kg)/meter (m)^2 to ≤35 kg/m^2.
Key exclusion criteria (29 listed)
- Has Screening laboratory values Grade ≥1 (younger adult, women of child-bearing potential, and pediatric participants) or >Grade 1 (older adult participants, including Japanese older adult participants).
- Is acutely ill or febrile on the day of the first injection.
- Has a significant medical history, including but not limited to:
- Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Nonstudy vaccinations should not be delayed.
- Has a history of myocarditis, pericarditis, or myopericarditis.
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-1345Formulation for injection | Biological | Cohort 10: Dose E in Older Adults, Cohort 11: Dose F in Older Adults, Cohort 12: Dose E in Women of Child-Bearing Potential, Cohort 13: Dose F in Women of Child-Bearing Potential, Cohort 14: Dose A in Women of Child-Bearing Potential, Cohort 15: Dose B in Japanese Older Adults, Cohort 1: Dose A in Younger Adults, Cohort 2: Dose B in Younger Adults, Cohort 3: Dose B in Younger Adults, Cohort 4: Dose C in Younger Adults, Cohort 5: Dose D in Children, Cohort 6: Dose G in Children, Cohort 7: Dose A in Older Adults, Cohort 8: Dose B in Older Adults, Cohort 9: Dose C in Older Adults |
| Placebo0.9% sodium chloride (normal saline) injection | Drug | Cohort 10: Dose E in Older Adults, Cohort 11: Dose F in Older Adults, Cohort 12: Dose E in Women of Child-Bearing Potential, Cohort 13: Dose F in Women of Child-Bearing Potential, Cohort 14: Dose A in Women of Child-Bearing Potential, Cohort 15: Dose B in Japanese Older Adults, Cohort 1: Dose A in Younger Adults, Cohort 2: Dose B in Younger Adults, Cohort 3: Dose B in Younger Adults, Cohort 4: Dose C in Younger Adults, Cohort 5: Dose D in Children, Cohort 6: Dose G in Children, Cohort 7: Dose A in Older Adults, Cohort 8: Dose B in Older Adults, Cohort 9: Dose C in Older Adults |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 737 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 758 (28 days after the last injection)
Number of Participants with Serious AEs or Medically Attended AEs (MAAEs)
Time frame: Up to Day 1095 (End of Study)
3 secondary outcomes
Geometric Mean Titer (GMT) of Serum RSV Neutralizing and Binding Antibodies (Abs)
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Geometric Mean Fold-Rise of Postbaseline/Baseline Ab Titers
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
Proportion of Participants with ≥2-fold and ≥4-fold Increases in Ab Titers from Baseline
Time frame: Up to Day 141 (Cohorts 5 and 6), up to Day 169 (Cohorts 1, 2, 4, 12, 13, 14, and 15), up to Day 281 (Cohort 3), and up to Day 1095 (Cohorts 7, 8, 9, 10, and 11)
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 7 Aug 2024.
- Derived from this study: PubMed 40953212Schnyder Ghamloush S, Fanning S, Essink B, Eder F, Snape MD, Stoszek SK, Guo R, Dhar R, Righi V, Morsy L, Kapoor A, El Asmar L, Shaw CA. Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months. Hum Vaccin Immunother. 2025 Dec;21(1):2557676. doi: 10.1080/21645515.2025.2557676. Epub 2025 Sep 15.
- Derived from this study: PubMed 39255587Fitz-Patrick D, Mihara H, Mills A, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Simorellis AK, Panozzo CA, Reuter C, Wilson E, Chen GL, Stoszek SK, Shaw CA, Goswami J. Safety and immunogenicity of an mRNA-based RSV vaccine in Japanese older adults aged >/=60 years: A phase 1, randomized, observer-blind, placebo-controlled trial. Respir Investig. 2024 Nov;62(6):1037-1043. doi: 10.1016/j.resinv.2024.08.011. Epub 2024 Sep 9.
- Derived from this study: PubMed 38385566Shaw CA, Essink B, Harper C, Mithani R, Kapoor A, Dhar R, Wilson L, Guo R, Panozzo CA, Wilson E, Simorellis AK, Reuter C, Stoszek SK, Chen GL, Das R, Goswami J. Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults. J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
- Derived from this study: PubMed 38298125Shaw CA, Mithani R, Kapoor A, Dhar R, Wilson L, El Asmar L, Schnyder-Ghamloush S, Schaefers K, August A, Stoszek SK, Chen GL. Safety, Tolerability, and Immunogenicity of an mRNA-Based Respiratory Syncytial Virus Vaccine in Healthy Young Adults in a Phase 1 Clinical Trial. J Infect Dis. 2024 Sep 23;230(3):e637-e646. doi: 10.1093/infdis/jiae035.
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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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 31 sites in United States.
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 13 inclusion and 29 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Adverse Reactions (ARs) (time frame: Up to Day 737 (7 days after each injection)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528719, which also lists 4 linked publications.
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 7 Aug 2024.