Adverse events of vaccination
Conditions
Interventions
0.2 mL of adsorbed Diphtheria-purified Pertussis-Tetanus Combined Vaccine (DTaP vaccine
KAKETSUKEN, lot number 42A)
0.5 mL of adsorbed Diphtheria-purified Pertussis-Tetanus Combined Vaccine (DTaP vaccine
KAKETSUKEN, lot number 42A)
Sponsors
Saga University
The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible criteria were follows: if they provided written informed consent if their antibodies levels against PT in 2010 were examined.
Exclusion criteria
Exclusion criteria: if their antibody level against PT was equal to or higher than 100 EU/mL in 2010; if they had any history of diphtheria, tetanus, and pertussis; if they had received any other drug or vaccine within 30 days of entry; if they had a history of allergic reactions to any vaccine component; if they had received immunoglobulins or any blood products; if they had an acute disease or a febrile illness at the time of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Booster response rates at 4 weeks after vaccination are at least 80% for PT, FHA, D, and T in both 0.2mL and 0.5mL of DTaP groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Higher geometric mean concentration (GMC) of antibodies in the 0.5-mL group at 4 weeks after booster vaccination. | — |
Countries
Japan
Contacts
Public ContactMegumi Hara
Saga University Preventive Medicine
Outcome results
None listed