BridgeMD
A study to investigate the reactogenicity, safety, and immunogenicity of mRNA-1345 in pregnant women, and safety and immunogenicity in their infants
EU CTIS ID: 2023-505359-37-00
What this study is testing
Maternal Participants- To evaluate the reactogenicity and safety of mRNA-1345 administered during pregnancy. Infant Participants: - To evaluate the safety profile in infants born to women vaccinated with mRNA-1345 during pregnancy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants are eligible to be included in the study only if all of the following criteria apply: Maternal Participants Age 1. Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
- Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy.
- Japanese women specific: Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
- Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations.
- Informed Consent - Are willing and able (on both a physical and cognitive basis) to give written informed consent for themselves and their unborn child prior to study enrollment, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.* *Consent of the individual identified as the co-parent of the unborn child to be obtained in addition, if required by local regulations.
- Infant Participants Informed Consent - Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations.
You likely can't join if
- Maternal Participants Weight - Body mass index of ≥40 kg/m2 at time of the Screening Visit.
- Other Exclusion Criteria Is a study site staff or first-degree relatives/partners of study site staff.
- 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 (eg, foster care). This does not include a child who is adopted or has an appointed LAR.
- Medical Conditions - Acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at the Screening Visit or Day 1. See Section 5.3 for guidance on rescreening.
- 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. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 60 days prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections
See the full eligibility criteria
Who can join
- Participants are eligible to be included in the study only if all of the following criteria apply: Maternal Participants Age 1. Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
- Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy.
- Japanese women specific: Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
- Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations.
- Informed Consent - Are willing and able (on both a physical and cognitive basis) to give written informed consent for themselves and their unborn child prior to study enrollment, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.* *Consent of the individual identified as the co-parent of the unborn child to be obtained in addition, if required by local regulations.
- Infant Participants Informed Consent - Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations.
- Type of Participant and Disease Characteristics 2. Healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests
- Will be 280/7 to 360/7 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report performed at 22 weeks or less; firsttrimester ultrasound is considered the gold standard for pregnancy dating). Details of the method for determination of the gestational age will be provided in the Study Operational Manual.
- Intend to reside within a geographic area in which emergency pediatric care is provided by a study-affiliated site.
- 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 (eg, phone, text message or email) with study site staff.
- Give permission for study site staff to access their/or their infant’s relevant medical information from other healthcare facilities should healthcare be sought at nonstudy facilities postenrollment.
What rules you out
- Maternal Participants Weight - Body mass index of ≥40 kg/m2 at time of the Screening Visit.
- Other Exclusion Criteria Is a study site staff or first-degree relatives/partners of study site staff.
- 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 (eg, foster care). This does not include a child who is adopted or has an appointed LAR.
- Medical Conditions - Acutely ill or febrile (temperature ≥38.0℃ [100.4°F]) within 72 hours prior to or at the Screening Visit or Day 1. See Section 5.3 for guidance on rescreening.
- 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. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 60 days prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections
- Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas).
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
- History of a bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- 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.
- History of myocarditis, pericarditis, or myopericarditis, regardless of the timing of the past medical history.
- Have an infection with HIV, HBV, HCV, syphilis, or laboratory test results at the Screening Visit outside the normal reference value for pregnant women according to their trimester in pregnancy.
- Intend for their infant to receive RSV monoclonal antibodies after delivery.
- Have conditions in the current pregnancy that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including but not limited to (refer to the Study Operational Manual for further details): a. Multiple pregnancies (eg, twins, triplets). b. Congenital malformation or clinically significant abnormalities on obstetric ultrasound. c. Congenital infection, including rubella, cytomegalovirus, toxoplasmosis, HSV (eg, primary genital HSV infection). d. Gestational hypertension, or preeclampsia. e. Antenatal hemorrhage. f. In-utero-growth restriction. g. Placental abnormality. h. Poly/oligohydramnios. i. Gestational diabetes. j. Pregnancy as a result of in vitro fertilization or other assisted reproductive technology. k. Threatened premature labor. l. Cervical insufficiency. m. Confirmed SARS-CoV-2 infection at any time during the pregnancy
- Had conditions in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including but not limited to (refer to the Study Operational Manual for further details): a. Stillbirth. b. Multiple (≥3) miscarriages. c. Cervical insufficiency. d. Grand multiparity (5 or greater previous pregnancies). e. Premature delivery (<34 weeks). f. Fetus or infant with known genetic disorder or congenital malformations. g. Preeclampsia. h. Gestational diabetes. i. Poly/oligohydramnios. j. D (Rhesus) sensitization.
- Prior/Concomitant Therapy - 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
- Received systemic immunosuppressants for >14 consecutive days in total within 180 days prior to the Screening Visit (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
- Received blood or plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt through delivery (excludes Rho[D)] immune globulin (eg, RhoGAM), which can be given at any time).
- Prior/Concurrent Clinical Study Experience Participated in another clinical research study where participant has received a study intervention (drug/biologic/device) within 180 days before Day 1. Current or previous participation in another RSV investigational study is exclusionary.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- United Kingdom
- Chile
- Japan
- Panama
- South Africa
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; United Kingdom; Chile; Japan; Panama; South Africa and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.