UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010672
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

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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 or person

Institute

Saga University

Institute

Department

Personal name



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

Value
https://center6.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