Clostridium Difficile Associated DiseasePhase 1NCT02725437
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
A Phase 1 study testing Clostridium difficile Vaccine in people with Clostridium Difficile Associated Disease, run by Pfizer at 2 sites in Japan.
Trial summary
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years. Read more about this study
- Who is it for?
- Ages 65 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
- 100 participants
- Where
- 2 sitesJapan
- Study dates
- Feb 2016to Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy male and female adults
- Aged 65 to 85 years
Who cannot join
- Proven or suspected prior episode of Clostridium difficile associated diarrhea
- Unstable chronic medical condition
- Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
- Serious chronic medical disorders
- Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
- Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
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- Subjects with congenital or acquired immunodeficiency disorders
- Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
- Active or treated leukemia or lymphoma or bone marrow disorder
- Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
- Abnormality in screening hematology and/or blood chemistry laboratory values
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Fukuoka, 812-0025
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, 130-0004
About this study
Official title: A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.
- Conditions
- Clostridium Difficile Associated Disease
- Being tested
- Clostridium difficile Vaccine, Placebo
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
PlaceboBiological
0.5 mL intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Low-dose C. difficile Vaccine (accelerated schedule) | Experimental | Not described Receives: Biological: Clostridium difficile Vaccine |
| High-dose C. difficile Vaccine (accelerated schedule) | Experimental | Not described Receives: Biological: Clostridium difficile Vaccine |
| Placebo (accelerated schedule) | Placebo comparator | Not described Receives: Biological: Placebo |
| Low-dose C. difficile Vaccine (non-accelerated schedule) | Experimental | Not described Receives: Biological: Clostridium difficile Vaccine |
| High-dose C. difficile Vaccine (non-accelerated schedule) | Experimental | Not described Receives: Biological: Clostridium difficile Vaccine |
| Placebo (non-accelerated schedule) | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
Measured: Up to 14 days after each vaccination
Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
Measured: Up to 14 days after each vaccination
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: From the first vaccination up to 28 days after the last vaccination
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: From the first vaccination until 6 months after the last vaccination
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
Measured: 7 days or 14 days after each vaccination
Secondary outcomes (8)
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations
Measured: Up to 6 months after dose 3
Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels
Measured: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels
Measured: Up to 6 months after dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725437
- Sponsor's protocol ID
- B5091010
- Status last verified
- Jul 2018
- First submitted
- 29 Jan 2016
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.
PubMed 30962095
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.
- ClinicalTrials.gov ID
- NCT02725437
- Acronym / sponsor ID
- B5091010
- Conditions
- Clostridium Difficile Associated Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Low-dose C. difficile Vaccine (accelerated schedule) | Experimental | Biological: Clostridium difficile Vaccine |
| High-dose C. difficile Vaccine (accelerated schedule) | Experimental | Biological: Clostridium difficile Vaccine |
| Placebo (accelerated schedule) | Placebo comparator | Biological: Placebo |
| Low-dose C. difficile Vaccine (non-accelerated schedule) | Experimental | Biological: Clostridium difficile Vaccine |
| High-dose C. difficile Vaccine (non-accelerated schedule) | Experimental | Biological: Clostridium difficile Vaccine |
| Placebo (non-accelerated schedule) | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy male and female adults
- Aged 65 to 85 years
Key exclusion criteria (11 listed)
- Proven or suspected prior episode of Clostridium difficile associated diarrhea
- Unstable chronic medical condition
- Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
- Serious chronic medical disorders
- Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
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 | Biological | High-dose C. difficile Vaccine (accelerated schedule), High-dose C. difficile Vaccine (non-accelerated schedule), Low-dose C. difficile Vaccine (accelerated schedule), Low-dose C. difficile Vaccine (non-accelerated schedule) |
| Placebo0.5 mL intramuscular injection | Biological | Placebo (accelerated schedule), Placebo (non-accelerated schedule) |
Primary outcome
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
Time frame: Up to 14 days after each vaccination
Proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries
Time frame: Up to 14 days after each vaccination
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Time frame: From the first vaccination up to 28 days after the last vaccination
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])
Time frame: From the first vaccination until 6 months after the last vaccination
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments
Time frame: 7 days or 14 days after each vaccination
8 secondary outcomes
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations
Time frame: Up to 6 months after dose 3
Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels
Time frame: Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels
Time frame: Up to 6 months after dose 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Derived from this study: PubMed 30962095Inoue M, Yonemura T, de Solom R, Yamaji M, Aizawa M, Knirsch C, Pride MW, Jansen KU, Gruber W, Webber C. A phase 1 randomized study assessing safety and immunogenicity of two 3-dose regimens of a Clostridium difficile vaccine in healthy older Japanese adults. Vaccine. 2019 May 1;37(19):2600-2607. doi: 10.1016/j.vaccine.2019.03.014. Epub 2019 Apr 5.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clostridium difficile Vaccine in people with Clostridium Difficile Associated Disease, run by Pfizer at 2 sites in Japan.
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 2 inclusion and 11 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries (time frame: Up to 14 days after each vaccination). The study lists 5 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 NCT02725437, which also lists 1 linked publication.
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 13 Jul 2018.