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

A Phase 2, Placebo-controlled, Randomised, Observer-blinded Trial To Evaluate The Safety, Tolerability And Immunogenicity Of A Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years

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.

Study Overview

• Status: Completed
• Conditions: Clostridium Difficile Associated Disease
• Intervention / Treatment: Biological: Clostridium difficile vaccine; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Nebraska
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research Center of Nevada, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • PMG Research of Charlotte
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research
    • San Angelo, Texas, United States, 76904
      • Benchmark Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Experimental: High dose of C. difficile vaccine	Biological: Clostridium difficile vaccine; 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Experimental: Low dose of C. difficile vaccine	Biological: Clostridium difficile vaccine; 0.5 mL intramuscular injection on day 1, day 8, and day 30.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 1 vaccination to within 7 days after Dose 1
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 2 vaccination to within 14 days after Dose 2
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 3 vaccination to within 14 days after Dose 3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 1 vaccination to within 7 days of Dose 1
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 2 vaccination to within 14 days after Dose 2
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 3 vaccination to within 14 days after Dose 3
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)	An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.	AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 1 vaccination to within 7 days of Dose 1
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 2 vaccination to 14 days after Dose 2
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)	Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.	From Day of Dose 3 vaccination to 14 days after Dose 3
Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 1 vaccination to within 7 days of Dose 1
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 2 vaccination to within 14 days after Dose 2
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)	Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.	From Day of Dose 3 vaccination to within 14 days after Dose 3
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)	An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.	AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: vaccine; Clostridium difficile
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: B5091003; 2013-004764-58 (EudraCT Number)