Respiratory Syncytial VirusPhase 2NCT06143046
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
A Phase 2 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 56 sites in 8 countries.
Trial summary
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 to vaccinated mothers. Read more about this study
- Who is it for?
- Ages 0 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- mRNA-1345
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 56 sitesin 8 countries
- Study dates
- 15 Nov 2023to 25 May 2026
- Phase
- Phase 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 0 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Maternal Participants
- Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
- Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report).
- Intend to deliver at a maternity unit where study procedures can be performed.
- Are willing and able to attend all study visits, to undergo all study procedures/or have their infant undergo all study procedures, and to comply with study requirements, including a means of communication (for example, phone, text message or email) with study site staff.
- Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy.
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- Have had an antenatal obstetric ultrasound at ≥18 weeks of pregnancy or be willing to have an antenatal obstetric ultrasound at Screening if not already conducted.
- Specific inclusion criteria for Japanese pregnant women:
- Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
- Infant Participants
- Have consent from infant participant's parent(s)/legally authorized representative (LAR) if required by local regulations.
Who cannot join
- Maternal Participants
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius [℃]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Have conditions in the current pregnancy or in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Received or plans to receive any mRNA vaccine or COVID-19 vaccine within 4 weeks before or after Day 1 and/or any other nonstudy vaccine within 2 weeks before or after Day 1.
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- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
- Intend for their infant to receive RSV monoclonal antibodies after delivery.
- Infant Participants
- Is a child who has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body acting in accordance with powers conferred on them by laws and regulation (for example, foster care). This does not include a child who is adopted or has an appointed LAR.
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
56 sites in 8 countries.
56 sites in 8 countries
United States22 sites
Velocity Clinical Research - Covington - PPDS
Covington, Louisiana, 70433-7237
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, 36305-7376
Matrix Clinical Research - Gardena
Gardena, California, 90247-4956
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
Grand Island, Nebraska, 68803-4327
Boeson Research GTF - Great Falls - ERN - PPDS
Great Falls, Montana, 59405-5316
Velocity Clinical Research (Hastings - Nebraska) - PPDS
Hastings, Nebraska, 68901-2615
DM Clinical Research - Bellaire - ERN - PPDS
Houston, Texas, 77081
Matrix Clinical Research - Huntington Park
Huntington Park, California, 90255-2913
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, 83404-5305
Boeson Research KAL - Kalispell - ERN - PPDS
Kalispell, Montana, 59901-2158
Maximos OB/GYN
League City, Texas, 77573-2681
Applied Research Center of Arkansas - ClinEdge - PPDS
Little Rock, Arkansas, 72212-4169
Matrix Clinical Research, Inc - Corporate Office
Los Angeles, California, 90057-4103
SMS Clinical Research
Mesquite, Texas, 75149
Boeson Research MSO - Missoula - ERN - PPDS
Missoula, Montana, 59804-7401
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
Norfolk, Nebraska, 68701-7701
Abby's Research Institute
Phoenix, Arizona, 85031-3878
Bingham Memorial Hospital
Pocatello, Idaho, 83201
Clinical Research Prime - ClinEdge - Rexburg - PPDS
Rexburg, Idaho, 83440-5390
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604-9533
Maternal Fetal Diagnostics Center
Salt Lake City, Utah, 84132-0001
Watching Over Mothers & Babies
Tucson, Arizona, 85712
South Africa8 sites
Josha Research
Bloemfontein, Free State, 9300
FAM-CRU
Cape Town, Western Cape, 7505
Ubuntu Clinical Research
Krugersdorp, Gauteng, 1739
Merclinico Middelburg
Middelburg, Mpumalanga, 1050
Bothe ke Bontle Health Services-316 Kuit st
Pretoria, Gauteng, 0184
Setshaba Research Centre
Soshanguve, Gauteng, 152
WITS Clinical Research Site - PPDS
Soweto, Gauteng, 2013
Drs. YAK Vahed & Partners
Welkom, Free State, 9459
United Kingdom7 sites
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
Cardiff & Vale University Health Board-PPDS
Cardiff, South Glamorgan, CF14 4XN
Glasgow Clinical Research Facility - PPDS
Glasgow, G51 4TF
The Royal London Hospital
London, London, City of, E1 1FR
The Royal Free Hospital
London, Middlesex, NW3 2QG
St George's Hospital
London, Surrey, SW17 0QT
Southampton General Hospital
Southampton, Hampshire
Panama5 sites
Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
David, Chiriquí Province
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
Panama City
Centro De Vacunacion Internacional, S.A. (Cevaxin)
Panama City
CEVAXIN 24 de diciembre
Panama City
Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
Pueblo Nuevo
Canada4 sites
Dalhousie University - 5820 University Ave
Halifax, Nova Scotia, B3H 1
Sainte Justine Hospital
Montreal, Quebec, H3T 1C5
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Centre Hospitalier de l'Université Laval
Québec, G1V 4G2
Japan4 sites
Shonan Kamakura General Hospital
Kamakura-Shi, Kanagawa, 247-8533
Saitama City Hospital
Saitama-Shi, Saitama, 336-0911
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655
Saiseikai Yokohamashi Nanbu Hospital
Yokohama, Kanagawa, 234-0054
Chile3 sites
Clínica Universidad de los Andes
Las Condes, Región-MetropolitanadeSantiago, 7550000
Centro Internacional de Estudios Clínicos
Recoleta, Región-MetropolitanadeSantiago, 8420000
Red Hospital Clinico de la Universidad de Chile
Santiago, 8380453
Denmark3 sites
Aarhus Universitetshospital
Aarhus, Central Jutland, 8200
Regionshospitalet Gødstrup
Herning, Central Jutland, 7400
Hvidovre Hospital
Hvidovre, Capital, DK-2650
About this study
Official title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity 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 to vaccinated mothers.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- mRNA-1345, Placebo
- Keywords
- mRNA-1345, RSV vaccine, Viral Diseases, Messenger RNA, Moderna
- 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
Sterile liquid for injection
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1345 Dose A | Experimental | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A. Receives: Biological: mRNA-1345 |
| mRNA-1345 Dose B | Experimental | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B. Receives: Biological: mRNA-1345 |
| mRNA-1345 Dose C | Experimental | Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C. Receives: Biological: mRNA-1345 |
| Placebo | Placebo comparator | Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Measured: Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Measured: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
Measured: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
Measured: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
Measured: Day 1 to Month 12 (12 months postdelivery)
Number of Infant Participants with MAAEs
Measured: Day 1 (birth) to Month 12
Number of Infant Participants with AESIs
Measured: Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
Measured: Day 1 (birth) to Month 12
Number of Infant Participants With Birth Outcomes
Birth outcomes will include gestational age and anthropometric measurements.
Measured: Day 1 (birth) to Month 12
Secondary outcomes (6)
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants
Measured: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants
Measured: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants
Measured: Day 29, delivery, and Month 6 (6 months postdelivery)
Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations
Measured: Baseline up to Month 6 (6 months postdelivery)
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants
Measured: Day 1 (birth), and Months 2, 6, and 12
GMC of Serum RSV-F Binding Antibodies in Infant Participants
Measured: Day 1 (birth), and Months 2, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start15 Nov 2023
- Primary completion25 May 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 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
- NCT06143046
- Sponsor's protocol ID
- mRNA-1345-P201
- Other IDs
- 2023-505359-37-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety and Immunogenicity in Infants Born to Vaccinated Mothers
- ClinicalTrials.gov ID
- NCT06143046
- Acronym / sponsor ID
- mRNA-1345-P201
- Conditions
- Respiratory Syncytial Virus
- Keywords
- mRNA-1345, RSV vaccine, Viral Diseases, Messenger RNA, Moderna
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 25 May 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 22 Nov 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 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 to vaccinated mothers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mRNA-1345 Dose A | Experimental | Biological: mRNA-1345Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A. |
| mRNA-1345 Dose B | Experimental | Biological: mRNA-1345Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B. |
| mRNA-1345 Dose C | Experimental | Biological: mRNA-1345Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation. |
Who may qualify
- Ages
- 0 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Maternal Participants
- Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
- Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report).
- Intend to deliver at a maternity unit where study procedures can be performed.
- Are willing and able to attend all study visits, to undergo all study procedures/or have their infant undergo all study procedures, and to comply with study requirements, including a means of communication (for example, phone, text message or email) with study site staff.
Key exclusion criteria (11 listed)
- Maternal Participants
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius [℃]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Have conditions in the current pregnancy or in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
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-1345Sterile liquid for injection | Biological | mRNA-1345 Dose A, mRNA-1345 Dose B, mRNA-1345 Dose C |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | Placebo |
Primary outcome
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
Time frame: Day 1 to Month 12 (12 months postdelivery)
Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
Number of Infant Participants with MAAEs
Time frame: Day 1 (birth) to Month 12
Number of Infant Participants with AESIs
Time frame: Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
Time frame: Day 1 (birth) to Month 12
Number of Infant Participants With Birth Outcomes
Time frame: Day 1 (birth) to Month 12
Birth outcomes will include gestational age and anthropometric measurements.
6 secondary outcomes
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants
Time frame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants
Time frame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants
Time frame: Day 29, delivery, and Month 6 (6 months postdelivery)
Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations
Time frame: Baseline up to Month 6 (6 months postdelivery)
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants
Time frame: Day 1 (birth), and Months 2, 6, and 12
GMC of Serum RSV-F Binding Antibodies in Infant Participants
Time frame: Day 1 (birth), and Months 2, 6, and 12
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 10 Jun 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.
56 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 56 sites in 8 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 11 inclusion and 11 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, South Africa, United Kingdom, Panama, Canada and 3 more countries. 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 phase mean?
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 Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Up to Day 7 (7 days post vaccination)). The study lists 11 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 10 Jun 2026.