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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
0.5 mL intramuscular injection
0.5 mL intramuscular injection
SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital)
Sumida-ku, Tokyo, Japan
SOUSEIKAI PS Clinic (formerly Medical Co. LTA PS Clinic)
Fukuoka, Japan
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
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
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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