E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (Prevention of invasive extraintestinal pathogenic Escherichia coli (ExPEC) disease) |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers (Prevention of E.coli infections) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Cohort 1: - To evaluate the safety and reactogenicity of different doses of ExPEC10V in participants ≥60 to ≤85 years of age - To evaluate the dose-dependent immunogenicity of ExPEC10V on Day 15 in participants ≥60 to ≤85 years of age
Cohort 2: - To evaluate the safety and reactogenicity of the selected dose of ExPEC10V in participants ≥60 years of age with a history of UTI in the past 5 years - To evaluate the immunogenicity of the selected dose of ExPEC10V on Day 30 in participants ≥60 years of age with a history of UTI in the past 5 years |
|
E.2.2 | Secondary objectives of the trial |
Cohort 1: - To evaluate the correlation between multiplex ECL-based immunoassay (total antibody) and MOPA (functional antibody) serum titers on Day 15 - To evaluate the dose-dependent immunogenicity of ExPEC10V on Days 30 and 181 - To evaluate, in the LTFU period, the safety and immunogenicity of the ExPEC10V dose selected for further clinical development based on the Day 30 primary analysis
Cohort 2: - To evaluate the correlation between multiplex ECL-based immunoassay (total antibody) and MOPA (functional antibody) serum titers on Day 30 - To evaluate the immunogenicity of the selected dose of ExPEC10V on Days 15 and 181 - To evaluate, in the LTFU period, the safety and immunogenicity of the selected dose of ExPEC10V |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Must have a body mass index (BMI) of greater than (>) 18.5 or less than (<) 40 kilogram per meter square (kg/m^2)
- Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
- Must be healthy or medically stable
- Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
- Agrees not to donate blood until 12 weeks after receiving the study vaccine |
|
E.4 | Principal exclusion criteria |
- Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic urinary tract infection (UTI); enrollment at a later date is permitted (provided the screening window of 28 days is respected)
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
- Applicable for Cohort 1 only: known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
- Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
- Abnormal function of the immune system
- Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Cohort 1: 1. Solicited local and systemic AEs collected for 14 days post-vaccination 2. Unsolicited AEs collected from the administration of the study vaccine until 29 days post-vaccination 3. Serious adverse events (SAEs) collected from the administration of the study vaccine until Day 181 4. Antibody titers for ExPEC10V, as determined by multiplex electrochemiluminescent (ECL)-based immunoassay and multiplex opsonophagocytic assay (MOPA) on Day 15
Cohort 2: 5. Solicited local and systemic AEs collected for 14 days post-vaccination 6. Unsolicited AEs collected from the administration of the study vaccine until 29 days post-vaccination 7. SAEs collected from the administration of the study vaccine until Day 181 8. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA on Day 30 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. From Day 1 to Day 15 2. From Day 1 to Day 30 3. From Day 1 to Day 181 4. Day 15 5. From Day 1 to Day 15 6. From Day 1 to Day 30 7. From Day 1 to Day 181 8. Day 30 |
|
E.5.2 | Secondary end point(s) |
Cohort 1: 1. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA on Day 15 2. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA on Days 30 and 181 3. SAEs related to the study vaccine or study procedures collected from Day 182 until the end of the study 4. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA at Year 1 (Day 366), Year 2 (Day 731) and Year 3 (Day 1096)
Cohort 2: 5. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA on Day 30 6. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA on Days 15 and 181 7. SAEs related to the study vaccine or study procedures collected from Day 182 until the end of the study 8. Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA at Year 1 (Day 366), Year 2 (Day 731), and Year 3 (Day 1096) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 15 2. Days 30 and 181 3. From Day 182 until the end of the study 4. At Year 1 (Day 366), Year 2 (Day 731) and Year 3 (Day 1096) 5. Day 30 6. Days 15 and 181 7. From Day 182 until the end of the study 8. At Year 1 (Day 366), Year 2 (Day 731), and Year 3 (Day 1096) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Reactogenicity and Immunogenicity |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
France |
Netherlands |
Spain |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 2 |