A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A VACCINE AGAINST E COLI IN HEALTHY ADULTS
Pfizer
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.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- Yes
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…
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
Locations (11)
- Anaheim Clinical Trials, LLCAnaheim, California
- Orange County Research CenterLake Forest, California
- Diablo Clinical Research, Inc.Walnut Creek, California
- Miami Eye InstituteHollywood, Florida
- Research Centers of AmericaHollywood, Florida
- NYU Langone HealthNew York, New York