Phase 2 N=42 Randomized Triple-blind Prevention

A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

Clostridium Difficile Associated Disease

Bottom Line

View on ClinicalTrials.gov: NCT02117570 ↗

Enrolled (actual)

Serious AEs

7.6%

Results posted

Jan 2017

Primary outcome: Primary: Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) — 16.7; 16.7; 50.0; 16.7 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Clostridium difficile vaccine (Biological); Placebo (Biological)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)	16.7; 16.7; 50.0; 16.7; 16.7; 50.0	—
PRIMARY Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)	0.0; 61.1; 66.7; 0.0; 44.4; 55.6	—
PRIMARY Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)	0.0; 23.5; 44.4; 0.0; 23.5; 38.9	—
PRIMARY Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)	0.0; 5.6; 5.6; 0.0; 5.6; 5.6	—
PRIMARY Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)	0.0; 0.0; 5.6; 0.0; 0.0; 0.0	—
PRIMARY Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)	16.7; 33.3; 50.0; 16.7; 11.1; 0	—
PRIMARY Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)	9.5; 24.6; 30.0; 9.5; 21.3; 28.3	—
PRIMARY Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)	5.9; 66.0; 64.0; 5.9; 45.3; 48.0	—
PRIMARY Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)	0.0; 25.0; 25.0; 0.0; 16.7; 16.7	—
PRIMARY Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)	0.0; 0.0; 3.3; 0.0; 0.0; 1.7	—
PRIMARY Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)	0.0; 1.9; 4.0; 0.0; 0.0; 2.0	—
PRIMARY Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
PRIMARY Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)	38.1; 36.1; 41.7; 14.3; 3.3; 10.0	—

Summary

This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Eligibility Criteria

Inclusion Criteria

Healthy male and female subjects aged 50 to 85 years

Exclusion Criteria

Proven or suspected prior episode of Clostridium difficile associated diarrhea.

Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.

Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02117570). 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.