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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000494
Receipt No. R000000602
Scientific Title Clinical study of influenza vaccine in infants; dose and immunogenicity
Date of disclosure of the study information 2006/09/29
Last modified on 2007/10/01

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Basic information
Public title Clinical study of influenza vaccine in infants; dose and immunogenicity
Acronym Clinical study of influenza vaccine in infants; dose and immunogenicity
Scientific Title Clinical study of influenza vaccine in infants; dose and immunogenicity
Scientific Title:Acronym Clinical study of influenza vaccine in infants; dose and immunogenicity
Region
Japan

Condition
Condition influenza
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess dose and immunogenicity of influenza vaccine by measuring antibody titer before and after vaccination in infants under 4 years old.
Dosage: Infants 6months and older to under 3 years old; 0.25mL
Infants 3 years and older to under 4 years old; 0.5mL
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HI titers before and after vaccination.
Survey on side reaction after vaccination.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Influenza HA vaccine is inoculated twice at 4 weeks interval. Side reaction survey and antibody titer measurement are conducted after inoculations.
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
6 months-old <=
Age-upper limit
48 months-old >
Gender Male and Female
Key inclusion criteria Infants who visit a medical institution to have vaccination and who fulfill all of the following criteria:
1.Healthy infants under 4 years old at the time of acquisition of consent.
2.Infants whose acceptable representatives consent to participate in this research in written.
Key exclusion criteria 1.Infants with a fever at the time of planned vaccination.
2.Infants with serious acute diseases.
3.Infants who has induced anaphylaxis by the substances of the vaccine.
4.Infants considered inappropriate to be inoculated vaccine.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Irie
Organization Medical Co. LTA Kyushu Clinical Pharmacology Research Clinic
Division name Clinical Pharmacology Department
Zip code
Address 2-13-16 Jigyo Chuo-ku, Fukuoka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Medical Co. LTA Kyushu Clinical Pharmacology Research Clinic
Division name Clinical Pharmacology Department
Zip code
Address 2-13-16 Jigyo Chuo-ku, Fukuoka
TEL
Homepage URL
Email

Sponsor
Institute The Research Foundation for Microbial Diseases of Osaka University
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2006 Year 09 Month 29 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
2006 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2007 Year 05 Month 01 Day
Date of closure to data entry
2007 Year 10 Month 01 Day
Date trial data considered complete
2007 Year 10 Month 01 Day
Date analysis concluded
2007 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 09 Month 29 Day
Last modified on
2007 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000602

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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