NCT01896830

Brief Summary

The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population. Primary objectives:

  • To describe the safety profile of all subjects who receive at least 1 injection
  • To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

July 8, 2013

Last Update Submit

July 13, 2018

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile infectionClostridium difficile Toxoid Vaccine

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring Throughout the Trial

    Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.

    Day 0 up to Day 60 post-vaccination

  • Serum antibody concentrations to toxins A and B, measured by enzyme-linked immunosorbent assay (ELISA)

    Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)

    Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination

  • Serum antibody titers against toxins A and B, measured by toxin neutralizing assay

    Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)

    Day 0 pre-vaccination, Days 14, 30 and 60 post-vaccination

Study Arms (2)

Vaccine Group

EXPERIMENTAL

Participants will receive the candidate C. difficile toxoid vaccine

Biological: Clostridium difficile Toxoid Vaccine

Placebo Group

PLACEBO COMPARATOR

Participants will receive a placebo vaccine

Biological: 0.9% normal saline

Interventions

Clostridium difficile Toxoid VaccineBIOLOGICAL

0.5 mL, intramuscular

Vaccine Group
0.9% normal salineBIOLOGICAL

0.5 mL, intramuscular

Also known as: NaCl
Placebo Group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

  • Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
  • Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine.
  • Planned receipt of any vaccine between study vaccinations and in the 4 weeks following the last trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
  • Previous vaccination against C. difficile with either the trial vaccine another vaccine, or monoclonal antibodies
  • Self-reported current or prior Clostridium difficile infection (CDI) episode
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components (including aluminum hydroxide, sodium citrate,sucrose, formaldehyde, sodium chloride), or history of a life-threatening reaction to a vaccine containing any of the same substances
  • Known medical history or concomitant disease of thrombocytopenia
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
  • Subjects who have any history of intestinal diverticular bleeding
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Osaka, 532-0003, Japan

Location

Related Publications (1)

  • Matsuoka O, Patel DM, Sasaki S, Oka H, Sasaki T, Pietrobon PJ, Laot T, Bouckenooghe A, Menezes J, de Bruyn G. Safety and immunogenicity of Clostridium difficile toxoid vaccine in Japanese adults. Hum Vaccin Immunother. 2018 Feb 1;14(2):322-328. doi: 10.1080/21645515.2017.1395538. Epub 2017 Dec 6.

    PMID: 29116880RESULT

MeSH Terms

Conditions

Clostridium Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Medical Director

    Sanofi Pasteur K.K

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 11, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

June 1, 2014

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

JP(1)