A Phase 3 Randomized Double-blind Controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of ExPEC9V and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 959
- 试验地点
- 75
- 主要终点
- Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
研究概览
简要总结
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy during the 6 weeks before enrollment and when hospitalization for worsening of the disease is not anticipated. Participants will be included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination
- •Participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- •Must sign an ICF indicating that the participant understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- •Willing and able to adhere to the lifestyle restrictions specified in this protocol
- •Agrees to not donate blood from the time of vaccination until 3 months after receiving the last dose of study vaccine
排除标准
- •History of an underlying clinically significant acute or uncontrolled chronic medical condition or significant cognitive impairment or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- •Known or suspected allergy or history of severe allergic reaction, anaphylaxis, or other serious adverse reactions to vaccines or vaccine excipients
- •History of severe allergic reactions (for example anaphylaxis) to any component of the high-dose (HD) quadrivalent seasonal influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
- •Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the first study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
- •History of acute polyneuropathy (for example, Guillain-Barré syndrome) or chronic inflammatory demyelinating polyneuropathy
研究组 & 干预措施
Group 2: Control Group
Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.
干预措施: HD quadrivalent influenza vaccine (Biological)
Group 2: Control Group
Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.
干预措施: ExPEC9V (Biological)
Group 1: Coadministration (CoAd) Group
Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30.
干预措施: ExPEC9V (Biological)
Group 1: Coadministration (CoAd) Group
Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30.
干预措施: Placebo (Biological)
Group 1: Coadministration (CoAd) Group
Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30.
干预措施: HD quadrivalent influenza vaccine (Biological)
Group 2: Control Group
Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30.
干预措施: Placebo (Biological)
结局指标
主要结局
Hemagglutination Inhibition (HI) Antibody Titers Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of High-Dose (HD) Quadrivalent Seasonal Influenza Vaccine
时间窗: 29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30)
HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-Based Immunoassay 29 Days After Administration of ExPEC9V
时间窗: CoAd Group: 29 days after the administration of ExPEC9V on Day 1 (Day 30); Control Group: 29 days after the administration of ExPEC9V on Day 30 (Day 59)
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 1
时间窗: 29 days after administration of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1 (Day 30)
Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay 29 days after administration of ExPEC9V on Day 1 will be reported.
Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
时间窗: 29 days after High-dose (HD) quadrivalent influenza vaccination on Day 1 (Day 30)
HI antibody titers measured by HI assay against each of the four influenza vaccine strains will be reported.
Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Electrochemiluminescent (ECL)-based Immunoassay 29 days After Administration of ExPEC9V on Day 30
时间窗: 29 days after administration of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 30 (Day 59)
Antibody titers to vaccine O-serotype antigens as determined by multiplex ECL-based immunoassay 29 days after administration of ExPEC9V on Day 30 will be reported.
次要结局
- Percentage of Participants With Seroconversion Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine(29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30))
- Percentage of Participants With Seroprotection Against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza Vaccine Strains 29 Days After the Administration of HD Quadrivalent Seasonal Influenza Vaccine(29 days after the administration of HD quadrivalent seasonal influenza vaccine on Day 1 (Day 30))
- Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination(Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44))
- Percentage of Participants With Solicited Systemic AEs for 14 Days After Each Vaccination(Up to 14 days post-vaccination 1 on Day 1 (Day 1 up to Day 15) and up to 14 days post-vaccination 2 on Day 30 (Day 30 up to Day 44))
- Percentage of Participants With Unsolicited AEs for 29 Days After Each Vaccination(Up to 29 days post-vaccination 1 on Day 1 (Day 1 up to Day 30) and up to 29 days post-vaccination 2 on Day 30 (Day 30 up to Day 59))
- Control Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)(29 days after the administration of ExPEC9V vaccine on Day 30 (Day 59))
- Percentage of Participants With Medically-attended Adverse Events (MAAEs) From Vaccination 1 Until 6 Months After Vaccination 2(From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210))
- Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 Until 6 Months After Vaccination 2(From vaccination 1 on Day 1 up to 6 months after vaccination 2 on Day 30 (up to Day 210))
- Geometric Mean Titers of O-serotype Antigens and EPA as Determined by Multiplex ECL-based Immunoassay(CoAd Group: Day 1 (Day of ExPEC9V vaccination), Day 30 (29 days after ExPEC9V vaccination), Day 59 (58 days after ExPEC9V vaccination); Control Group: Day 30 (Day of ExPEC9V vaccination), Day 59 (29 days after ExPEC9V vaccination))
- CoAd Group: Opsonophagocytic Geometric Mean Titers of O-serotype Antigens as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)(29 days after the administration of ExPEC9V vaccine on Day 1 (Day 30))
- CoAd Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of Urinary Tract Infection (UTI) at Enrollment as Determined by Multiplex ECL-based Immunoassay(29 days after the administration of ExPEC9V on Day 1 (Day 30))
- Control Group: Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex ECL-based Immunoassay(29 days after the administration of ExPEC9V on Day 30 (Day 59))
- CoAd Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)(29 days after the administration of ExPEC9V on Day 1 (Day 30))
- Control Group: Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens in Participants With and Without History of UTI at Enrollment as Determined by Multiplex Opsonophagocytic Killing Assay (MOPA)(29 days after the administration of ExPEC9V on Day 30 (Day 59))
- Percentage of Seroprotected Participants(29 days after HD quadrivalent influenza vaccination on Day 1 (Day 30))
- Antibody Titers to Vaccine O-serotype Antigens and Exotoxin a Derived from Pseudomonas Aeruginosa (EPA) as Determined by Multiplex ECL-based Immunoassay(At days 1, 30, and 59)
- Percentage of Participants with Serious Adverse Events (SAEs) From Vaccination 1 to Until 6 Months After Vaccination 2(From vaccination 1 (on Day 1) till 6 months after vaccination 2 (on Day 30), that is until Day 210)
- Percentage of Seroconverted Participants(29 days after HD quadrivalent influenza vaccination on Day 1 (Day 30))
- Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) for 14 Days After Each Vaccination(14 days post-vaccination 1 on Day 1 (Day 15) and post-vaccination 2 on Day 30 (Day 44))
- Percentage of Participants with Solicited Systemic AEs for 14 Days After Each Vaccination(14 days post-vaccination 1 on Day 1 (Day 15) and post-vaccination 2 on Day 30 (Day 44))
- Percentage of Participants with Unsolicited AEs for 29 Days After Each Vaccination(29 days post-vaccination 1 on Day 1 (Day 30) and post-vaccination 2 on Day 30 (Day 59))
- Percentage of Participants with Medically-attended Adverse Events (MAAEs) From Vaccination 1 to Until 6 Months After Vaccination 2(From vaccination 1 (on Day 1) till 6 months after vaccination 2 (on Day 30), that is until Day 210)
- Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) 29 Days After Administration of ExPEC9V on Day 1 (Day 30)(29 days after administration of ExPEC9V on Day 1 (Day 30))
- Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 1 (Day 30) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment(29 days after administration of ExPEC9V on Day 1 (Day 30))
- Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex Opsonophagocytic Assay (MOPA) 29 Days After Administration of ExPEC9V on Day 30 (Day 59)(29 days after administration of ExPEC9V on Day 30 (Day 59))
- Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by MOPA 29 days after administration of ExPEC9V on Day 1 (Day 30) in participants with or without History of UTI at Enrollment(29 days after administration of ExPEC9V on Day 1 (Day 30))
- Antibody Titers to Vaccine O-serotype Antigens as Determined by Multiplex ECL-based Immunoassay 29 days after administration of ExPEC9V on Day 30 (Day 59) in participants with or without History of Urinary Tract Infection (UTI) at Enrollment(29 days after administration of ExPEC9V on Day 30 (Day 59))
- Opsonophagocytic Antibody Titers to Vaccine O-serotype Antigens as Determined by MOPA 29 days after administration of ExPEC9V on Day 30 (Day 59) in participants with or without History of UTI at Enrollment(29 days after administration of ExPEC9V on Day 30 (Day 59))