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

Clostridium Difficile Associated Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725437
• Other study ID #: B5091010
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Associated Disease

Intervention

Biological:
• Clostridium difficile Vaccine
0.5 mL intramuscular injection
• Placebo
0.5 mL intramuscular injection

Locations

Country	Name	City	State
Japan	SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)	Fukuoka
Japan	SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)	Sumida-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments		7 days or 14 days after each vaccination
Secondary	Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations		Up to 6 months after dose 3
Secondary	Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels		Up to 6 months after dose 3
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels		Up to 6 months after dose 3
Secondary	Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels		Up to 6 months after dose 3
Secondary	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

External Links

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