Clostridium Difficile Vaccine Efficacy Trial

Exclusion Criteria

• •Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• •Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
• •Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
• •Prior episode of CDI..
• •Receipt of blood products or immunoglobulins within 6 months before enrollment.
• •Subjects who may be unable to respond to vaccination due to:
• •* Metastatic malignancy; or
• •* End-stage renal disease; or
• •* Any serious medical disorder likely to be fatal within the next 12 months; or
• •* Congenital or acquired immunodeficiency; or
• •* Receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or
• •* Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.
• •Known infection with human immunodeficiency virus (HIV).
• •Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.
• •Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
• •Prior small- or large-bowel resection.
• •Any condition or treatment resulting in frequent diarrhea.
• •Other acute or chronic condition or abnormality that may increase the risk associated with study participation or IP administration or may interfere with interpretation of study results
• •Pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception