A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Multivalent Influenza and Respiratory Syncytial Virus (RSV)/Human Metapneumovirus (hMPV)/Parainfluenza Virus Type 3 (PIV3) Vaccines 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
- 270
- 试验地点
- 6
- 主要终点
- Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
研究概览
简要总结
The objective of this study is to evaluate the safety and immunogenicity of different vaccines of hemagglutinin formulations of trivalent influenza vaccine or of a combined respiratory syncytial virus / human metapneumovirus / parainfluenza virus type 3 vaccine in healthy participants 18 to 49 years of age. A lipid nanoparticle will be used in this study.
Overall, the study is designed to:
- Assess the safety profile of the candidate formulations
- Describe the immunogenicity profile of the candidate formulations
- Eligible participants will be randomized to receive a single intramuscular injection of either one of the vaccine formulations.
Participants will be provided with a diary to solicit reporting of injection site reactions and systemic reactions, unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest AESIs).
Participants will also be required to record their daily temperature on the diary.
详细描述
The duration of study participation will be approximately 6 months for each participant.
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)
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 one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile OR
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
排除标准
- •- Any medical condition or circumstance 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
Group 1 trivalent influenza vaccine-hemagglutinin (TIV-HA) formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
干预措施: TIV-HA formulation 1 at high dose (Biological)
Group 2 TIV-HA formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
干预措施: TIV-HA formulation 2 at high dose (Biological)
Group 3 TIV-HA formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
干预措施: TIV-HA Vaccine formulation 1 at low dose (Biological)
Group 4 TIV-HA formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the TIV-HA vaccines according to their randomization schedule.
干预措施: TIV-HA formulation 2 at low dose (Biological)
Group 5 RSV/hMPV/PIV3 formulation 1 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
干预措施: RSV/hMPV/PIV3 formulation 1 at high dose (Biological)
Group 6 RSV/hMPV/PIV3 formulation 2 at high dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
干预措施: RSV/hMPV/PIV3 formulation 2 at high dose (Biological)
Group 7 RSV/hMPV/PIV3 formulation 1 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
干预措施: RSV/hMPV/PIV3 formulation 1 at low dose (Biological)
Group 8 RSV/hMPV/PIV3 formulation 2 at low dose
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV/PIV3 vaccines according to their randomization schedule.
干预措施: RSV/hMPV/PIV3 formulation 2 at low dose (Biological)
Group 9 recombinant influenza vaccine quadrivalent (RIV4)
Participants will receive a single IM (Intramuscular) injection on day 1 of the RIV4 vaccine according to their randomization schedule.
干预措施: RIV4 (Supemtek®) (Biological)
结局指标
主要结局
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
时间窗: Within 30 minutes after each vaccination
Number of participants with unsolicited systemic AEs
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
时间窗: Through 7 days after each vaccination
Number of participants with solicited injection site and systemic reactions
Presence of unsolicited AEs reported through 28 days after vaccination
时间窗: Through 28 days after each vaccination
Number of participants with unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study
时间窗: Throughout study, approximately 6 months
: Number of participants with SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
时间窗: Through 7 days after vaccination
: Number of participants with out-of-range biological tests
Hemagglutinin Inhibition Assay (HAI) antibody (Ab) response to each homologous influenza strain at Day 1 and Day 29
时间窗: Day 1 and Day 29
RSV A, hMPV A and PIV3 serum neutralizing antibodies (nAb) titers at Day 1 and Day 29
时间窗: Day 1 and Day 29
次要结局
- RSV B and hMPV A nAb titers at Day 1 and Day 29(Day 1 and Day 29)
- Neutralization Test (NT) Ab response to each homologous influenza strain at Day 29(Day 29)