Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japa
Not Applicable
- Conditions
- Adverse events of vaccination
- Registration Number
- JPRN-UMIN000010672
- Lead Sponsor
- Saga University
- Brief Summary
Significant increases were found in the antibodies against pertussis toxin, filamentous hemagglutinin, diphtheria toxoid, and tetanus toxoid after booster vaccination in both groups, and the booster response rates for all reached 100%.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Higher geometric mean concentration (GMC) of antibodies in the 0.5-mL group at 4 weeks after booster vaccination.