Clostridium Difficile Associated DiseasePhase 2NCT02117570

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 study testing Clostridium difficile vaccine in people with Clostridium Difficile Associated Disease, run by Pfizer at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Clostridium Difficile Associated Disease
What is being tested?: Clostridium difficile vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 185 participants
Where: 12 sitesUnited States
Study dates: Jul 2014to Dec 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male and female subjects aged 50 to 85 years

Who cannot join

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

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

Other trials in United States

About this study

Official title: 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

Conditions: Clostridium Difficile Associated Disease
Being tested: Clostridium difficile vaccine, Placebo
Keywords: Clostridium difficile, vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clostridium difficile vaccineBiological
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Clostridium difficile vaccineBiological
0.5 mL intramuscular injection on day 1, day 8, and day 30.
PlaceboBiological
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.

Study groups in NCT02117570
Study group	Role	What they receive
High dose of C. difficile vaccine	Experimental	Not described Receives: Biological: Clostridium difficile vaccine
Low dose of C. difficile vaccine	Experimental	Not described Receives: Biological: Clostridium difficile vaccine
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Dec 2015

First posted21 Apr 2014 (estimated)
Study startJul 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Clostridium Difficile Associated DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02117570
Sponsor's protocol ID: B5091003
Other IDs: 2013-004764-58
Status last verified: Nov 2016
First submitted: 16 Apr 2014
Last updated: 30 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Dysbiosis, Clostridium Difficile
RecruitingObservational study
Natural History of Clostridioides Difficile Infection
Clostridium Difficile Infection, Health Care Associated Infection
RecruitingPhase 2/3
Secondary Prevention of Clostridioides Difficile Using Vancomycin
Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence
RecruitingObservational study
Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis
Ulcerative Colitis

All Clostridium Difficile Associated Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02117570
Acronym / sponsor ID: B5091003
Conditions: Clostridium Difficile Associated Disease
Keywords: Clostridium difficile, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 21 Apr 2014 (estimated)
Results: Posted 30 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High dose of C. difficile vaccine	Experimental	Biological: Clostridium difficile vaccine
Low dose of C. difficile vaccine	Experimental	Biological: Clostridium difficile vaccine
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy male and female subjects aged 50 to 85 years

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clostridium difficile vaccine0.5 mL intramuscular injection on day 1, day 8, and day 30.	Biological	High dose of C. difficile vaccine
Clostridium difficile vaccine0.5 mL intramuscular injection on day 1, day 8, and day 30.	Biological	Low dose of C. difficile vaccine
PlaceboPlacebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.	Biological	Placebo

Primary outcome

Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 1 vaccination to within 7 days after Dose 1
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.
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
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.
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
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.
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)
Time frame: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
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.
Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 2 vaccination to 14 days after Dose 2
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.
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 3 vaccination to 14 days after Dose 3
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.
Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
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.
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)
Time frame: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
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.

Results and safety

Results posted to the registry on 30 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	5
Clostridium Difficile Vaccine, 100 µg	18	15
Clostridium Difficile Vaccine, 200 µg	18	17

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

Time frame: From Day of Dose 1 vaccination to within 7 days after Dose 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo n = 6	Clostridium Difficile Vaccine, 100 µg n = 18	Clostridium Difficile Vaccine, 200 µg n = 18
Pain at injection site: Any	16.7 (0.4 to 64.1)	16.7 (3.6 to 41.4)	50.0 (26.0 to 74.0)
Pain at injection site: Mild	16.7 (0.4 to 64.1)	16.7 (3.6 to 41.4)	50.0 (26.0 to 74.0)
Pain at injection site: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Pain at injection site: Severe	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Pain at injection site: Grade 4	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Redness: Any	0.0 (0.0 to 45.9)	5.6 (0.1 to 27.3)	5.6 (0.1 to 27.3)
Redness: Mild	0.0 (0.0 to 45.9)	5.6 (0.1 to 27.3)	0.0 (0.0 to 18.5)
Redness: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	5.6 (0.1 to 27.3)

Population analysed: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine

Primary outcome: Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)

Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo n = 6	Clostridium Difficile Vaccine, 100 µg n = 18	Clostridium Difficile Vaccine, 200 µg n = 18
Pain at injection site: Any	0.0 (0.0 to 45.9)	61.1 (35.7 to 82.7)	66.7 (41.0 to 86.7)
Pain at injection site: Mild	0.0 (0.0 to 45.9)	44.4 (21.5 to 69.2)	55.6 (30.8 to 78.5)
Pain at injection site: Moderate	0.0 (0.0 to 45.9)	16.7 (3.6 to 41.4)	11.1 (1.4 to 34.7)
Pain at injection site: Severe	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Pain at injection site: Grade 4	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Redness: Any	16.7 (0.4 to 64.1)	11.1 (1.4 to 34.7)	50.0 (26.0 to 74.0)
Redness: Mild	16.7 (0.4 to 64.1)	11.1 (1.4 to 34.7)	27.8 (9.7 to 53.5)
Redness: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	22.2 (6.4 to 47.6)

Population analysed: All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine

Primary outcome: Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)

Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo n = 6	Clostridium Difficile Vaccine, 100 µg n = 17	Clostridium Difficile Vaccine, 200 µg n = 18
Pain at injection site: Any	0.0 (0.0 to 45.9)	23.5 (6.8 to 49.9)	44.4 (21.5 to 69.2)
Pain at injection site: Mild	0.0 (0.0 to 45.9)	23.5 (6.8 to 49.9)	38.9 (17.3 to 64.3)
Pain at injection site: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	5.6 (0.1 to 27.3)
Pain at injection site: Severe	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	0.0 (0.0 to 18.5)
Pain at injection site: Grade 4	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	0.0 (0.0 to 18.5)
Redness: Any	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	44.4 (21.5 to 69.2)
Redness: Mild	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	22.2 (6.4 to 47.6)
Redness: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 19.5)	22.2 (6.4 to 47.6)

Population analysed: All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.

Primary outcome: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)

Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Placebo n = 6	Clostridium Difficile Vaccine, 100 µg n = 18	Clostridium Difficile Vaccine, 200 µg n = 18
Fever: Any	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Fever: Mild	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Fever: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Fever: Severe	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Fever: Grade 4	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)
Vomiting: Any	16.7 (0.4 to 64.1)	5.6 (0.1 to 27.3)	0.0 (0.0 to 18.5)
Vomiting: Mild	16.7 (0.4 to 64.1)	5.6 (0.1 to 27.3)	0.0 (0.0 to 18.5)
Vomiting: Moderate	0.0 (0.0 to 45.9)	0.0 (0.0 to 18.5)	0.0 (0.0 to 18.5)

Population analysed: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine

Adverse events

Time frame: Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (50-64 Year Age Cohort)	1 of 6 (16.7%)	0 of 6 (0%)	Not reported
Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)	2 of 18 (11.1%)	5 of 18 (27.8%)	Not reported
Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)	0 of 18 (0%)	9 of 18 (50%)	Not reported
Placebo (65-85 Year Age Cohort)	3 of 21 (14.3%)	5 of 21 (23.8%)	Not reported
Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)	2 of 61 (3.3%)	22 of 61 (36.1%)	Not reported
Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)	6 of 60 (10%)	22 of 60 (36.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clostridium difficile vaccine in people with Clostridium Difficile Associated Disease, run by Pfizer at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) (time frame: From Day of Dose 1 vaccination to within 7 days after Dose 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02117570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.