Unique ID issued by UMIN | UMIN000010672 |
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Receipt number | R000012479 |
Scientific Title | Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan |
Date of disclosure of the study information | 2013/05/08 |
Last modified on | 2013/05/08 16:58:52 |
Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan
Immunogenicity and safety after booster vaccination of DTP in young adults
Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan
Immunogenicity and safety after booster vaccination of DTP in young adults
Japan |
Adverse events of vaccination
Infectious disease |
Others
NO
To evaluate the immunogenicity and safety of booster vaccination of DTaP vaccine in young adults in Japan.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
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
Higher geometric mean concentration (GMC) of antibodies in the 0.5-mL group at 4 weeks after booster vaccination.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Dose comparison
YES
NO
Institution is not considered as adjustment factor.
YES
Pseudo-randomization
2
Treatment
Vaccine |
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)
18 | years-old | <= |
20 | years-old | >= |
Male and Female
Eligible criteria were follows:
if they provided written informed consent
if their antibodies levels against PT in 2010 were examined.
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.
100
1st name | |
Middle name | |
Last name | Megumi Hara |
Saga University
Department of Medicine
5-1-1 Nabeshima Saga-city, Saga, Japan
0952-34-2289
1st name | |
Middle name | |
Last name | Megumi Hara |
Saga University
Preventive Medicine
5-1-1 Nabeshima Saga-city, Saga, Japan
0952-34-2289
harameg@cc.saga-u.ac.jp
Saga University
Health and Labour Science Research Grants
Japan
The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
None
NO
佐賀大学医学部(佐賀県)
2013 | Year | 05 | Month | 08 | Day |
Unpublished
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%.
Completed
2011 | Year | 06 | Month | 15 | Day |
2011 | Year | 08 | Month | 01 | Day |
2012 | Year | 03 | Month | 31 | Day |
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
Both GMCs and GMCRs against all antigens were significantly higher in the 0.5-mL group than in the 0.2-mL group.
2013 | Year | 05 | Month | 08 | Day |
2013 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012479
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