臨床研究等提出・公開システム

Date of registration	July. 04, 2024
Last modified on	May. 14, 2025
Trial ID	jRCT2061240030

Scientific Title	Use-result survey of GOBIK Aqueous Suspension Syringes
Public Title	Use-result survey of GOBIK Aqueous Suspension Syringes

Contact for Scientific Queries	Name	Fujii Takeshi
	Affiliation	The Research Foundation for Microbial Diseases of Osaka University
	Address	4-1-70,SETO-CHO,KAN-ONJI,KAGAWA
	Telephone	+81-875-25-4835
	E-mail	gpsp@mail.biken.or.jp
Contact for Public Queries	Name	Fujii Takeshi
	Affiliation	The Research Foundation for Microbial Diseases of Osaka University
	Address	4-1-70,SETO-CHO,KAN-ONJI,KAGAWA
	Telephone	+81-875-25-4835
	E-mail	gpsp@mail.biken.or.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 22, 2024
Target sample size		1500
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Children who have received the vaccine as primary immunization or booster immunization
	Exclusion Criteria	none
	Age Minimum	0age 2month old over
	Age Maximum	15age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Prevention of pertussis,diphtheria,tetanus,poliomyelitis and invasive disease due to Hib infections
Primary Outcome(s)		safety:Rate of vaccine-related adverse event, Factors that may influence safety, Rate of serious vaccine-related adverse event

Primary Sponsor	The Research Foundation for Microbial Diseases of Osaka University

Name of Certified Review Board	none
Address	4-1-70,SETO-CHO,KAN-ONJI,KAGAWA, Kagawa

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	May. 14, 2025	(this page)	Changes
1	July. 04, 2024	Detail

List of change history