UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of rotavirus vaccine in infants admitting NICU; comparison between RV1 and RV5.
Title of the study (Brief title)	Safety and efficacy of rotavirus vaccine in infants admitting NICU.
Region	Japan

Condition
Condition	Infants in NICU
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To elucidate safety and efficacy of rotavirus vaccine in infants admitting NICU.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Spreading of rotavirus vaccine strains in NICU.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Vaccine
Interventions/Control_1	RV1 rotavirus vaccine
Interventions/Control_2	RV5 rotavirus vaccine
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	Not applicable
Age-upper limit	32 weeks-old >=
Gender	Male and Female
Key inclusion criteria	Infants in NICU that meet to the requirements for rotavirus vaccine.
Key exclusion criteria	Underlying diseases associated with gastrointestinal disease.
Target sample size	40

Research contact person
Name of lead principal investigator	Tetsushi Yoshikawa
Organization	Fujita Health University School of Medicine
Division name	Dept. of Pediatrics
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL	+81-562-93-9251
Email	tetsushi@fujita-hu.ac.jp

Public contact
Name of contact person	Tetsushi Yoshikawa
Organization	Fujita Health University School of Medicine
Division name	Dept. of Pediatrics
Address	1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi.Japan
TEL	+81-562-93-9251
Homepage URL
Email	tetsushi@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University School of Medicine. Dept. of Pediatrics
Institute
Department

Funding Source
Organization	Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 06 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019117