Diphtheria, pertussis, and tetanus
Conditions
Interventions
Additional inoculation of DPT (diphtheria, pertussis, and tetanus) vaccine is conducted for the infant participants who have received routine vaccinations of diphtheria, pertussis, tetanus, inactivate
Sponsors
Shizuo Shindo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy volunteers* of Japanese infants whose antibody titer after the study drug inoculation was measured in the BK1310 J03 study (excluding early terminated participants in the BK1310 J03 study) * Healthy volunteers: Those who did not have any active diseases (acute disease, chronic disease, or aggravated chronic progressive disease) requiring treatment or follow-up, and those receiving medication(s) to control active disease(s) well. (2)Candidate participants whose legally acceptable representative has consented to the study participation and those who have provided their assent to the study participation. (3) Participants who are compliant with the clinical research in receiving physical exams and tests, and reporting symptoms, etc.
Exclusion criteria
Exclusion criteria: (1) Those who have ever received any vaccine, other than the BK1310 J03 study, that includes the active ingredient of inactivated Polio, pertussis, diphtheria, tetanus, or Hemophilus influenzae type b (excluding a vaccine with an ingredient of either one of the above as carrier protein). (2) Those who have experienced anaphylaxis due to ingredients of TRIBIK as documented. (3) Those who have or as a complication of severe (i.e., extremely bad health conditions requiring long-term treatment or follow-up) cardiovascular, hematologic, hepatic, nephritic, gastroenterological, metabolic, or psychoneurotic diseases. (4) Those who have any disease related to an apparent immune abnormality, or those who have received any treatment leading to immunosuppression* as documented. * Any treatment leading to immunosuppression: Immunosuppressive agent/ therapy, anti-rheumatic agent, hematopoietic agent (excluding ion pill or other agent without immunosuppressive effect), adrenal corticosteroid (excluding topical agent, ophthalmic solution, and inhaler), interferon, carcinostatic agent, radiation therapy, etc. (5) Those who have received a transfusion or gamma globulin agent within 90 days of the research drug inoculation, or those who have received a high-dose therapy of gamma globulin agent (more than 200mg/kg) within 180 days of the research drug inoculation. (6) Those who have received unapproved drug/therapy within 120 days of the research drug inoculation. (7) Those who are deemed ineligible for the research by the Research PI/Sub-I.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of antibody prevalence rate against diphtheria toxin, tetanus toxin, and Bordetella pertussis protective antigen (PT, FHA) before and after the research drug inoculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of booster response rate against diphtheria toxin, tetanus toxin, and Bordetella pertussis protective antigen (PT, FHA) before and after the research drug inoculation. Comparison of antibody seroconversion rate, GMT (geometric mean titers), and amplitude of GMT variation against diphtheria toxin, tetanus toxin, and Bordetella pertussis protective antigen (PT, FHA) before and after the research drug inoculation | — |
Contacts
Public ContactTakada Ryuta
MEDISCIENCE PLANNING, Inc.
Outcome results
None listed