Phase 1
N=48
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Clostridium Infections
Bottom Line
View on ClinicalTrials.gov: NCT00214461 ↗Enrolled (actual)
48
Serious AEs
4.2%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine. — 3; 8; 4; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Vaccine diluent buffer (Placebo) (Biological); C. difficile toxoid vaccine (2 µg) (Biological); C. difficile toxoid vaccine (10 µg) (Biological); C. difficile toxoid vaccine (50 µg) (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine. |
3; 8; 4; 8; 4; 5 | — |
| SECONDARY Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine. |
0; 0; 1; 3; 0; 2 | — |
Summary
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Eligibility Criteria
Inclusion Criteria
- Adult males or females, > or = 65 years
- In good general health
- Clinical lab tests within normal range
- Females must be post-menopausal
- Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Exclusion Criteria
- Evidence of C. difficile infection
- Evidence of any previous antibiotic-associated diarrhea
- Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
- History of malignancy within 5 years
- History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
- Known or suspected history of immunodeficiency
- Active or inactive immune-mediated or inflammatory disease
- History of drug or alcohol abuse disorders;
- Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Receipt of antibiotic therapy or an investigational drug within prior 30 days
- Blood or organ donation within prior 30 days.
Data sourced from ClinicalTrials.gov (NCT00214461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.