Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

Phase 1

Completed

• Conditions: Clostridium Difficile Associated Disease
• Interventions: Biological: Clostridium difficile Vaccine; Biological: Placebo

• Registration Number: NCT02725437
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-29
• Study Start: 2016-02
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-11
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Healthy male and female adults
2. Aged 65 to 85 years

Exclusion Criteria

1. Proven or suspected prior episode of Clostridium difficile associated diarrhea
2. Unstable chronic medical condition
3. Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
4. Serious chronic medical disorders
5. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
6. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
7. Subjects with congenital or acquired immunodeficiency disorders
8. Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
9. Active or treated leukemia or lymphoma or bone marrow disorder
10. Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
11. Abnormality in screening hematology and/or blood chemistry laboratory values

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose C. difficile Vaccine (accelerated schedule)	Clostridium difficile Vaccine	-
Low-dose C. difficile Vaccine (accelerated schedule)	Clostridium difficile Vaccine	-
Placebo (accelerated schedule)	Placebo	-
Low-dose C. difficile Vaccine (non-accelerated schedule)	Clostridium difficile Vaccine	-
High-dose C. difficile Vaccine (non-accelerated schedule)	Clostridium difficile Vaccine	-
Placebo (non-accelerated schedule)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])	From the first vaccination up to 28 days after the last 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	Up to 14 days after each vaccination
Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])	From the first vaccination until 6 months after the last vaccination
Proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries	Up to 14 days after each vaccination
Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments	7 days or 14 days after each vaccination

Secondary Outcome Measures

Name	Time	Method
Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels	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	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	Up to 6 months after dose 3
Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations	Up to 6 months after dose 3
Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels	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	Up to 6 months after dose 3
Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels	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	Up to 6 months after dose 3

Trial Locations

Locations (2)

SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital); 🇯🇵 Sumida-ku, Tokyo, Japan

SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic); 🇯🇵 Fukuoka, Japan