UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016570 |
|---|---|
| Receipt number | 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 16:42:29 |
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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
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
4combi-study@c-ctd.co.jp
Sponsor or person
Institute
The Japanese Society for Vaccinology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019218
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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