Last updated on March 2019

Clostridium Difficile Vaccine Efficacy Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions: Clostridium Difficile | Clostridium difficile
• Age: Between 60 - 100 Years
• Gender: Male or Female

• Other:
  Evidence of a personally signed and dated informed consent document.
  Willing and able to comply with study procedures.
  Subjects with an increased risk of future contact with healthcare systems or subjects
  who have received systemic antibiotics in the previous 12 weeks.
  Ability to be contacted by telephone during study participation.
  Negative urine pregnancy test for female subjects of childbearing potential.
  

You may not be eligible for this study if the following are true:

• 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
  ubjects 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
  tudy results
  Pregnant or breastfeeding female subjects; male subjects and female subjects who are
  exually active and at risk for pregnancy and will not/cannot use 2 methods of
  contraception