E. coli infection invasive extraintestinal pathogenic E. coli (ExPEC) disease
Conditions
Interventions
Cohort 2:
- 1 administration of the study vaccine EXPEC10V (selected dose from cohort 1)
on day 1 of the study.
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Must have a body mass index (BMI) of >18.5 to
Exclusion criteria
Exclusion criteria: - Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >=38.0ºC (100.4°F) within 24 hours prior to the administration of study vaccine, or, applicable for Cohort 2 only, an ongoing or suspected symptomatic UTI; enrollment at a later date is permitted (provided the screening window of 28days 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 (refer to Investigator's Brochure); - Contraindication to IM injections and blood draws eg, bleeding disorders; - Abnormal function of the immune system - Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited local and systemic AEs collected for 14 days post-vaccination (Solicited (local and systemic) AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the participant ediary) Unsolicited AEs collected from the administration of the study vaccine until 29 days post-vaccination (Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participantediary). SAEs collected from the administration of the study vaccineuntil Day 181 Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassayand MOPA on Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassayand MOPA on Day30 Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay on Days15 and 181 and MOPA on Day 181 SAEs related to the study vaccine or study procedures collected from Day 182 until the end of the study Antibody titers for ExPEC10V, as determined by multiplex ECL-based immunoassay and MOPA at Year 1 (Day 366) | — |
Countries
Netherlands
Outcome results
None listed