Healthy Participants
Conditions
Brief summary
This study evaluates an investigational vaccine designed to protect against Escherichia coli (E coli). The primary objective is to assess the safety and tolerability of E coli vaccines administered intramuscularly to healthy adults.
Interventions
DRUGE coli vaccine 1 Dose A
Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval
DRUGE coli vaccine 1 Dose B
Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval
DRUGE coli vaccine 2
Candidate E coli vaccine 2, administered according to a 0, 6-month interval
DRUGE coli vaccine 3
Candidate E coli vaccine 3, administered according to a 0, 6-month interval
DRUGE coli Vaccine 4 Dose A
Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval
DRUGE coli Vaccine 4 Dose B
Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval
DRUGE coli Vaccine 4 Dose C
Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval
DRUGE coli Vaccine 5 Dose A
Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval
DRUGE coli Vaccine 5 Dose B
Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval
DRUGPlacebo
Placebo administered according to a 0, 6-month interval
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Key Inclusion Criteria 1. Adult Participants \>= 18 through \< 64 years of age at the time of enrollment. 2. Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study. Key
Exclusion criteria
1. Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 2. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 3. Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting prespecified local events within 7 days following each vaccination | 7 days after each vaccination | Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination |
| Percentage of participants reporting prespecified systemic events within 7 days following each vaccination | 7 days after each vaccination | Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination |
| Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention | From signing of ICD to 1 month after the last assigned vaccination | Adverse events occurring up to 1 month after the last dose of study intervention |
| Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention | Baseline up to month 18 with final visit being 12 months after last assigned vaccination | MAEs occurring up to 12 months after the last dose of study intervention |
| Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention | Baseline up to month 18 with final visit being 12 months after last assigned vaccination | SAEs occurring up to 12 months after the last dose of study intervention |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed