Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDI... | NCT00772343

Studies
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

NCT00772343

Sponsor

Sanofi Pasteur, a Sanofi Company

Status

Completed

Last Update Posted

Sep 17, 2013Estimated

Enrollment

116Actual

Phase

Phase 2

Conditions

Diarrhea
Clostridium Difficile Infection

Interventions

0.9% Normal Saline
Clostridium difficile toxoid vaccine
Clostridium difficile toxoid vaccine with adjuvant
Clostridium difficile toxoid vaccine

Countries

United States
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2008-004907-69	EudraCT Number
28439/0001/001	Other Identifier	MHRA

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 10, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jun 28, 2012

Certification/Extension First Submitted that Passed QC Review

Jun 28, 2012

Certification/Extension First Posted Date

Jul 2, 2012Estimated

Last Update Submitted Date

Sep 6, 2013

Last Update Posted Date

Sep 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care.

Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

Detailed Description

This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their first event of CDI and are being treated with the antibiotic standard of care. This study will be conducted in the United States and United Kingdom. Adult subjects with limited chronic disease, who are currently receiving treatment for their first episode of CDI will be enrolled in this trial. Subjects will be required to be able to take oral antibiotics.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo Vaccine	Placebo Comparator	0.9% Normal saline	Biological: 0.9% Normal Saline
Low dose	Experimental	Low dose vaccine with adjuvant	Biological: Clostridium difficile toxoid vaccine
High dose 1	Experimental	High-dose vaccine with adjuvant	Biological: Clostridium difficile toxoid vaccine with adjuvant
High dose 2	Experimental	High-dose vaccine without adjuvant	Biological: Clostridium difficile toxoid vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.9% Normal Saline	Biological	0.5 mL, intramuscular on Days 0, 7, and 28	Placebo Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence of Clostridium difficile infection.		Approximately 13 weeks after last injection

Secondary Outcomes

Measure	Description	Time Frame
Safety and immunogenicity		Approximately 13 weeks after last injection.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
Subjects who are medically stable.
Subjects who are willing and able to comply with the study procedures and visit schedules outlined.

Exclusion Criteria:

Subjects who are currently on treatment for a recurrence of CDI.
Subjects who are currently or have recently been treated with immunoglobulin therapy.
Pregnant or breast feeding females.
Concurrent, acutely life-threatening diseases.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Sanofi Pasteur Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Tampa	Florida	33614	United States

Label	URL
Related Info	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D000077330	Saline Solution
D000277	Adjuvants, Pharmaceutic

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D010592	Pharmaceutic Aids
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses