A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 390
- 试验地点
- 8
- 主要终点
- Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
研究概览
简要总结
The purpose of this phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
详细描述
The study duration will be up to approximately 12 months minus the screening period.
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, Investigator, Outcomes Assessor)
盲法说明
-Investigators, Sponsor and study site staff, laboratory personnel, and participants will be blinded. Study staff preparing/administering the study interventions will be unblinded. Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohorts
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
- •Informed consent form (ICF) has been signed and dated
- •A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- •Note: 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
PIV3 Dose 2
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: parainfluenza virus type 3 vaccine (PIV3) (Biological)
PIV3 Dose 3
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: parainfluenza virus type 3 vaccine (PIV3) (Biological)
PIV3 Dose 4
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: parainfluenza virus type 3 vaccine (PIV3) (Biological)
RSV/hMPV /PIV3 Formulation 1
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: RSV/hMPV/PIV3 vaccine (Biological)
RSV/hMPV Formulation 1
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: RSV/hMPV vaccine (Biological)
PIV3 Dose 1
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: parainfluenza virus type 3 vaccine (PIV3) (Biological)
RSV/hMPV Formulation 2
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: RSV/hMPV vaccine (Biological)
RSV vaccine 1
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: RSV vaccine 1 (Biological)
RSV vaccine 2
Participants will receive a single intramuscular (IM) injection at Day 1
干预措施: RSV vaccine 2 (Biological)
结局指标
主要结局
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
时间窗: Within 30 minutes after each vaccination
Number of participants experiencing immediate unsolicited systemic AEs
Presence of solicited administration site reactions within 7 days after vaccination
时间窗: Within 7 days after vaccination
Number of participants reporting: - injection site reactions: pain, erythema and swelling
Presence of solicited systemic reactions within 7 days after vaccination
时间窗: Within 7 days after vaccination
Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of unsolicited AEs within 28 days after vaccination
时间窗: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of serious adverse events (SAEs)
时间窗: Within 6 months after vaccination
Number of participants experiencing SAEs regardless of causality
Presence of adverse events of special interest (AESIs)
时间窗: Within 6 months after vaccination
Number of participants experiencing AESIs regardless of causality
Presence of related SAEs throughout the study
时间窗: Throughout the study, approximately 12 months
Number of participants experiencing related SAEs regardless of causality
Presence of related AESIs throughout the study
时间窗: Throughout the study, approximately 12 months
Number of participants experiencing related AESIs regardless of causality
Presence of related fatal SAEs throughout the study
时间窗: Throughout the study, approximately 12 months
Number of participants experiencing related fatal SAEs regardless of causality
Presence of out-of-range biological test results (including shift from baseline values)
时间窗: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
次要结局
- RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines(At Day 01 and Day 29)
- RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines(At Day 01 and Day 29)
- hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines(At Day 01 and Day 29)
- PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines(At Day 01 and Day 29)