Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Label: Month 0, 1 and 3 Schedule | Experimental |
| |
| Day 1, 8, and 30 Schedule | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. difficile vaccine with adjuvant | Biological | C. difficile vaccine with adjuvant administered at Month 0, 1, and 3. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries. | 7 days after vaccination | |
| Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries. | 7 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s). | Up to 12 months post-dose 3 | |
| Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States | ||
| Vince & Associates Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Biological | Placebo administered at Month 0, 1, and 3. |
|
| C. difficile vaccine with adjuvant | Biological | C. difficile vaccine with adjuvant administered at day 1, 8, 30. |
|
| placebo | Biological | Placebo administered at Day 1, 8, and 30. |
|
| Up to 12 months post-dose 3 |
| Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL). | Up to 12 months post-dose 3 |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | United States |
| Carolina Phase I Research, LLC | Raleigh | North Carolina | 27612 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | United States |
| Manna Research Inc. | Toronto | Ontario | M9W 4L6 | Canada |
| Diex Research Montreal Inc | Montreal | Quebec | H4N 3C5 | Canada |
| Clinique Medicale St-Louis (recherche) Inc. | Québec | Quebec | G1W4R4 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided