A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infan… (NCT06143046) | Clinical Trial Compass
CompletedPhase 2
A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
United States, Canada, Chile360 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range
0 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
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.
* 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.
Key Exclusion Criteria:
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: Up to Day 7 (7 days post vaccination)
2
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 28 (28 days post vaccination)
3
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Timeframe: Day 1 to Month 6 (6 months postdelivery)
4
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 to Month 12 (12 months postdelivery)
5
Number of Maternal Participants with Serious Adverse Events (SAEs)
Timeframe: Day 1 to Month 12 (12 months postdelivery)
6
Number of Maternal Participants with AEs Leading to Discontinuation
Timeframe: Day 1 to Month 12 (12 months postdelivery)
7
Number of Maternal Participants With Pregnancy Outcomes