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Clostridium difficile toxoids A and B

Phase 2

Clostridium Difficile Infection | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jul 18, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment650

FDA Designations

No designations recorded

Clinical trial landscape

Clostridium difficile toxoids A and B · 1 trial · 2 indications

Phase 2 1
NCT01230957Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in AdultsClostridium Difficile Infection
COMPLETED650 Analytics
PHASE2COMPLETED
Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults
Clostridium Difficile Infection
NCT01230957650
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Study Endpoints

Primary Endpoints

Information concerning the safety profile in terms of solicited and unsolicited reactions in participants following vaccination with ACAM-CDIFF™ Vaccine.
6 days after each vaccination and up to 6 months post-vaccination 3
Serum antitoxin IgG concentrations to Clostridium difficile toxins A and B in participants vaccinated with ACAM-CDIFF™.
Up to 6 months post-vaccination 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALParticipants will receive a dose Low-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
Group 2EXPERIMENTALParticipants will receive a dose Low-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
Group 3EXPERIMENTALParticipants will receive a dose High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 30, respectively.
Group 4EXPERIMENTALParticipants will receive a dose High-dose ACAM-CDIFF™ vaccine without adjuvant on Day 0, 7, and 30, respectively.
Group 5PLACEBO_COMPARATORParticipants will receive a dose Placebo (0.9% normal saline) on Day 0, 7, and 30, respectively.
Group 6EXPERIMENTALParticipants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 7, and 180, respectively.
Group 7EXPERIMENTALParticipants will receive a dose of High-dose ACAM-CDIFF™ vaccine with adjuvant on Day 0, 30, and 180, respectively.

Interventions

NameTypeDescription
Clostridium difficile toxoids A and B (Low-dose with adjuvant)BIOLOGICAL0.5 mL, Intramuscular on Days 0, 7, and 30
Clostridium difficile toxoids A and B (Low-dose without adjuvant)BIOLOGICAL0.5 mL, Intramuscular on Days 0, 7, and 30
Clostridium difficile toxoids A and B (high-dose with adjuvant)BIOLOGICAL0.5 mL, Intramuscular on Days 0, 7, and 30
Clostridium difficile toxoids A and B (high-dose without adjuvant)BIOLOGICAL0.5 mL, Intramuscular on Days 0, 7, and 30
Placebo: 0.9% normal salineBIOLOGICAL0.5 mL, Intramuscular on Days 0, 7, and 30
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Eligibility Criteria

Age Range40 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites30

Inclusion Criteria: * Aged 40 to 75 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures * For a woman of childbearing potential, use of an effective method of contraception or abstinence from a...

Countries:United States
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