UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000494 |
|---|---|
| Receipt number | 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 10:15:44 |
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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
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
Sponsor or person
Institute
The Research Foundation for Microbial Diseases of Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000602
