A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 240
- 试验地点
- 12
- 主要终点
- Presence of any unsolicited systemic adverse events (aes)
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age.
-Each participant will remain in the study for approximately 6 months.
- The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01).
- The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Investigators, study site staff, laboratory personnel, outcome assessors, and participants will be blinded throughout the study. Study staff preparing and administering the study interventions will be unblinded throughout the study.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 49 years on the day of inclusion
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
- •Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
- •Is of CBP (Child-Bearing Potential) and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.
排除标准
- •Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
RSV Formulation 5
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 5 dose (Biological)
RSV Formulation 1
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 1 dose (Biological)
RSV Formulation 2
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 2 dose (Biological)
RSV Formulation 3
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 3 dose (Biological)
RSV Formulation 4
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 4 dose (Biological)
RSV Formulation 6
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 6 dose (Biological)
Control group 1 dose 1
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 7 dose (Biological)
Control group 2 dose 2
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
干预措施: RSV vaccine formulation 8 dose (Biological)
结局指标
主要结局
Presence of any unsolicited systemic adverse events (aes)
时间窗: Within 30 minutes after each vaccine injection
Number of participants experiencing immediate AEs
Presence of unsolicited AEs
时间窗: Day 1 through day 29
Number of participants experiencing unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
时间窗: Throughout study, approximately 6 months
Number of participants experiencing SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values)
时间窗: Through 7 days after each vaccine injection
number of participants with out-of-range biological tests
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
时间窗: Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site reactions
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
时间窗: Through 7 days after each vaccine injection
Number of participants experiencing solicited systemic reactions
RSV A nAb (Neutralizing Antibodies) titers
时间窗: At day 1 and day 29
次要结局
未报告次要终点