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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016570
Receipt No. R000019218
Scientific Title Assessment of time course of changes in antibody titers after vaccination with a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Salk vaccine): DTap-wIPV to consider necessity of booster vaccinations.
Date of disclosure of the study information 2015/02/18
Last modified on 2018/02/16

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Basic information
Public title Assessment of time course of changes in antibody titers after vaccination with a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Salk vaccine): DTap-wIPV to consider necessity of booster vaccinations.
Acronym DTap-wIPV to consider necessity of booster vaccinations.
Scientific Title Assessment of time course of changes in antibody titers after vaccination with a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Salk vaccine): DTap-wIPV to consider necessity of booster vaccinations.
Scientific Title:Acronym DTap-wIPV to consider necessity of booster vaccinations.
Region
Japan

Condition
Condition Healthy children
Classification by specialty
Infectious disease Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the durability of acquired immunity after DTaP-wIPV vaccination.
To evaluate the necessity of booster vaccination at the ages of 4-7 years.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Time course of changes in antibody titers
Time course of changes in titers of antibodies to PT, pertussis FHA, diphtheria, tetanus, and highly-virulent polioviruses (types 1, 2, and 3) at the ages of 4-7years after DTaP-wIPV vaccination
2) Prevalence of diseases
Pathological status of pertussis, diphtheria, tetanus, and VAPP until the time of blood collection
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
4 years-old <=
Age-upper limit
7 years-old >=
Gender Male and Female
Key inclusion criteria Children aged 4 years or older meeting the following criteria:
1) Subjects who participated in the preceding clinical trial of DTaP-wIPV (Protocol No.DD 687-A-J301) and were assigned to receive four doses of study vaccine DD-687(DTaP-wIPV).
2) Subjects for whom written informed consent is obtained from the subject's legal representative
Key exclusion criteria Not applicable
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Nakayama
Organization Kitasato Institute for Life Sciences
Division name Laboratory of Viral Infection I
Zip code
Address 5-9-1 Shirokane, Minato-Ku, Tokyo, 108-8641,Japan
TEL 03-3444-6161
Email tetsuo-n@lisci.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Izutsu
Organization CTD Inc.
Division name -
Zip code
Address 3-3-2Tsukiji,Chuo-ku,Tokyo,140-0045,Japan
TEL 03-6228-4835
Homepage URL
Email 4combi-study@c-ctd.co.jp

Sponsor
Institute The Japanese Society for Vaccinology
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Kitasato Daiichi Sankyo Vaccine Co., Ltd.
Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 千葉県、東京都、三重県、福岡県、鹿児島県、北海道

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 18 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
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
2015 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the durability of acquired immunity after DTaP-wIPV vaccination.
To evaluate the necessity of booster vaccination at the ages of 4-7 years.

Management information
Registered date
2015 Year 02 Month 18 Day
Last modified on
2018 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019218

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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