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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 56
- 主要终点
- Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Observer-blind study
入排标准
- 年龄范围
- 0 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Placebo
Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.
干预措施: Placebo (Biological)
mRNA-1345 Dose B
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.
干预措施: mRNA-1345 (Biological)
mRNA-1345 Dose C
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.
干预措施: mRNA-1345 (Biological)
mRNA-1345 Dose A
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.
干预措施: mRNA-1345 (Biological)
结局指标
主要结局
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
时间窗: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
时间窗: Day 1 to Month 12 (12 months postdelivery)
Number of Infant Participants with MAAEs
时间窗: Day 1 (birth) to Month 12
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
时间窗: Up to Day 7 (7 days post vaccination)
Number of Infant Participants with AESIs
时间窗: Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
时间窗: Day 1 (birth) to Month 12
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
时间窗: Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
时间窗: Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
时间窗: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
时间窗: 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 Birth Outcomes
时间窗: Day 1 (birth) to Month 12
Birth outcomes will include gestational age and anthropometric measurements.
次要结局
- Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants(Day 1, Day 29, delivery, and Month 6 (6 months postdelivery))
- GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants(Day 1 (birth), and Months 2, 6, and 12)
- GMC of Serum RSV-F Binding Antibodies in Infant Participants(Day 1 (birth), and Months 2, 6, and 12)
- Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants(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(Baseline up to Month 6 (6 months postdelivery))
- Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants(Day 1, Day 29, delivery, and Month 6 (6 months postdelivery))