Tetanus Clinical Trial
Official title:
Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled
Verified date | November 2020 |
Source | Mitsubishi Tanabe Pharma Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.
Status | Completed |
Enrollment | 267 |
Est. completion date | August 10, 2020 |
Est. primary completion date | September 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 42 Months |
Eligibility | Inclusion Criteria: - Healthy infants aged =2 and <43 months at the first vaccination of the study drug (recommended: =2 and <7 months) - Written informed consent is obtained from a legal guardian (parent) Exclusion Criteria: - Possibility of anaphylaxis due to food or pharmaceuticals - With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis - With experience of Hib, diphteria, pertussis, tetanus or polio vaccination. - Participated in other studies within 12 weeks before obtaining consent - Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment Additional screening criteria check may apply for qualification. |
Country | Name | City | State |
---|---|---|---|
Japan | Investigational Site | Fukuoka-shi | Fukuoka |
Lead Sponsor | Collaborator |
---|---|
Mitsubishi Tanabe Pharma Corporation | The Research Foundation for Microbial Diseases of Osaka University |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody prevalence rate against anti-PRP with 1 µg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus | 4 weeks after the primary immunization (Visit 4) | ||
Secondary | Anti-PRP antibody prevalence rate with 0.15 µg/mL or higher | 4weeks after the primary immunization (Visit 4) | ||
Secondary | Geometric mean antibody titer of anti-PRP antibody | 4weeks after the primary immunization (Visit 4) | ||
Secondary | Anti-PRP antibody prevalence rate with 1 µg/mL or higher | 4weeks after the booster dose (Visit 6) | ||
Secondary | Geometric mean antibody titer of anti-PRP antibody | 4weeks after the booster dose (Visit 6) | ||
Secondary | Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus | 4weeks after the primary immunization (Visit 4) | ||
Secondary | Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus | 4weeks after the booster dose (Visit 6) | ||
Secondary | Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus | 4weeks after the booster dose (Visit 6) | ||
Secondary | Adverse events and adverse reactions | Through study completion, an average of 1 year |
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