UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006988 |
|---|---|
| Receipt number | R000008242 |
| Scientific Title | Surveillance for nasopharyungeal carriage of S.pneumoniae in young children of Okinawa. |
| Date of disclosure of the study information | 2012/01/05 |
| Last modified on | 2016/01/08 15:59:39 |
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Basic information
Public title
Surveillance for nasopharyungeal carriage of S.pneumoniae in young children of Okinawa.
Acronym
Surveillance for nasopharyngeal carriage of S.pneumoniae in young children of Okinawa.
Scientific Title
Surveillance for nasopharyungeal carriage of S.pneumoniae in young children of Okinawa.
Scientific Title:Acronym
Surveillance for nasopharyngeal carriage of S.pneumoniae in young children of Okinawa.
Region
| Japan |
Condition
Condition
Nasopharyngeal carriage of S.pneumoniae.
Classification by specialty
| Pneumology | Infectious disease | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current study is designed to show the serotyp of S.pneumoniae from nasopharyngeal carriage of young children in the phase of PCV7 and PCV13 vaccination in Okinawa.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serotyping of S.pneumoniae from nasopharyngeal carriage of healthy young children.
Key secondary outcomes
Risk factor analysis of nasopharyngeal carriage : sibling,childcare attendance.
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
| Not applicable |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nasopharyngeal carriage monitoring: Nasopharyngeal swabs are taken from afebrile 2 to 24 month old children who visit 4 clinics for any vaccination under informed consent.Number of NP swabs target are about 800 in each 2012 and 2015.
Key exclusion criteria
None
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hedeki Akeda |
Organization
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center
Division name
Pediatric general medicine
Zip code
Address
118-1 Arakawa, Haebaru-cho, Okinawa, Japan
TEL
81-98-888-0123
akeda_hideki@hosp.pref.okinawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takanami |
Organization
The Okinawa Society of Child Health
Division name
Okinawa pediatric Pneumococcal disease zero-project office
Zip code
Address
218-11 Arakawa, Haebaru-cho, Okinawa, Japan
TEL
81-98-963-8462
Homepage URL
http://www.osh.or.jp/
vpd@osh.or.jp
Sponsor or person
Institute
Hideki Akeda
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Okinawa Society of Child Health
Name of secondary funder(s)
Health and labor science research grants
{Research on regulatory science of pharmaceuticals and medical devices}
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
| 2012 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Result of surveillance of nasopharyngeal carriage in 2012 was published in 2015 (World Journal Of Vaccine 2015,5,88-95).
Abstract:PCV7 was subsidized by the national funding system from 2011.After that PCV7 were immunized universally. Carriage rate of S.pneumoniae in healthy 2 to 24 month old children was 24.8% (180/725). Carriage of PCV7 serotypes accounted for 21.8%. The result of multivariate data analysis showed that the pneumococcal carriage rate of non-PCV7 serotypes was significantly high in infant with sibling and daycare attendance.On the other hand, carriage rate of PCV7 serotypes had only significantly high risk in infant with siblings and did not have a risk dependent on daycare attendance.
The result demonstrates that PCV7 vaccination decrease the overall nasopharyngeal carriage of PCV7 serotypes in vaccinated children including children at risk such as attending daycare.
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Surveillance of nasopharyngeal carriage in 2015 is ongoing. Effects of PCV13 will be analyzed by the new surveillance.
Management information
Registered date
| 2011 | Year | 12 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008242
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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