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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010672
Receipt No. 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

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Basic information
Public title Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan
Acronym Immunogenicity and safety after booster vaccination of DTP in young adults
Scientific Title Immunogenicity and safety after booster vaccination of diphtheria, tetanus, and acellular pertussis in young adults: an open randomized controlled trial in Japan
Scientific Title:Acronym Immunogenicity and safety after booster vaccination of DTP in young adults
Region
Japan

Condition
Condition Adverse events of vaccination
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the immunogenicity and safety of booster vaccination of DTaP vaccine in young adults in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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
Key secondary outcomes Higher geometric mean concentration (GMC) of antibodies in the 0.5-mL group at 4 weeks after booster vaccination.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 0.2 mL of adsorbed Diphtheria-purified Pertussis-Tetanus Combined Vaccine (DTaP vaccine; KAKETSUKEN, lot number 42A)
Interventions/Control_2 0.5 mL of adsorbed Diphtheria-purified Pertussis-Tetanus Combined Vaccine (DTaP vaccine; KAKETSUKEN, lot number 42A)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria Eligible criteria were follows:
if they provided written informed consent
if their antibodies levels against PT in 2010 were examined.
Key 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.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Hara
Organization Saga University
Division name Department of Medicine
Zip code
Address 5-1-1 Nabeshima Saga-city, Saga, Japan
TEL 0952-34-2289
Email

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Hara
Organization Saga University
Division name Preventive Medicine
Zip code
Address 5-1-1 Nabeshima Saga-city, Saga, Japan
TEL 0952-34-2289
Homepage URL
Email harameg@cc.saga-u.ac.jp

Sponsor
Institute Saga University
Institute
Department

Funding Source
Organization Health and Labour Science Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 佐賀大学医学部(佐賀県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 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%.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information Both GMCs and GMCRs against all antigens were significantly higher in the 0.5-mL group than in the 0.2-mL group.

Management information
Registered date
2013 Year 05 Month 08 Day
Last modified on
2013 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012479

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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