UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010996 |
|---|---|
| Receipt number | R000012797 |
| Scientific Title | Nasopharyngeal Colonization, Distribution of Serotypes, and Antimicrobial Drug Susceptibility among Streptococcus pneumoniae / Haemophilus influenzae before and after Introducing of 7-valent Pneumococcal Conjugate Vaccine and H.influenzae type b vaccine in Sado, Japan -SADO Birth Cohort study- |
| Date of disclosure of the study information | 2013/06/19 |
| Last modified on | 2017/07/03 16:42:09 |
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Basic information
Public title
Nasopharyngeal Colonization, Distribution of Serotypes, and Antimicrobial Drug Susceptibility among Streptococcus pneumoniae / Haemophilus influenzae before and after Introducing of 7-valent Pneumococcal Conjugate Vaccine and H.influenzae type b vaccine in Sado, Japan -SADO Birth Cohort study-
Acronym
Nasopharyngeal Colonization, Distribution of Serotypes, and Antimicrobial Drug Susceptibility among Streptococcus pneumoniae / Haemophilus influenzae before and after Introducing of PCV7 and Hib vaccine in Sado, Japan -SADO Birth Cohort study-
Scientific Title
Nasopharyngeal Colonization, Distribution of Serotypes, and Antimicrobial Drug Susceptibility among Streptococcus pneumoniae / Haemophilus influenzae before and after Introducing of 7-valent Pneumococcal Conjugate Vaccine and H.influenzae type b vaccine in Sado, Japan -SADO Birth Cohort study-
Scientific Title:Acronym
Nasopharyngeal Colonization, Distribution of Serotypes, and Antimicrobial Drug Susceptibility among Streptococcus pneumoniae / Haemophilus influenzae before and after Introducing of PCV7 and Hib vaccine in Sado, Japan -SADO Birth Cohort study-
Region
| Japan |
Condition
Condition
Nasopharyngeal carriage
Classification by specialty
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of PCV7 and Hib vaccine in nasopharyngeal carriage of S. pneumoniae and H. influenza. and to evaluate the relation between nasopharyngeal carriage on before and after PCV7 and serotype-specific immune reaction.
Basic objectives2
Others
Basic objectives -Others
Colonization rate of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
2. Capsular serotypes of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Colonization rate of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
2. Capsular serotypes of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
Key secondary outcomes
1. Minimum inhibitory concentration (MIC) of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
2. Antimicrobial resistance genes of S. pneumoniae and H. influenzae at 1-, 4-, 7-, 10-, 18-, 36-month of age.
3. Serum antibody titer of infant aged a month carried pneumococcus in pre-and post- PCV7 vaccination
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
7-valent Pneumococcal Conjugate Vaccine and H.influenzae type b vaccine
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
| 1 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Newborns born in Sado Island from July 1, 2012 to June 30, 2013.
2. Their guardians could understand the summary of the study.
3. Their guardians gave written informed consent before conducting this study.
Key exclusion criteria
1. Newborns had plan to move to other areas within 3 years
2. Newborns had congenital malformation.
3. For other reasons, newborns determined to be inappropriate for study entry by investigator.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera Wakayama-shi, Wakayama, Japan.
TEL
073-441-0751
mhotomi@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muneki Hotomi |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera Wakayama-shi, Wakayama, Japan.
TEL
073-441-0751
Homepage URL
mhotomi@wakayama-med.ac.jp
Sponsor or person
Institute
Otolaryngology-Head and Neck Surgery, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata welfare Federation of Agricultural Cooperative Associations, the Federation of Agricultural Cooperative Unions Sado general hospital
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
和歌山県立医科大学（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 19 | 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
| 2011 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 18 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012797
