UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Tetsuo Nakayama
Organization	Kitasato Institute for Life Sciences
Division name	Laboratory of Viral Infection I
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	Miwa Izutsu
Organization	CTD Inc.
Division name	-
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019218