UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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	Muneki Hotomi
Organization	Wakayama Medical University
Division name	Otolaryngology-Head and Neck Surgery
Address	811-1 Kimiidera Wakayama-shi, Wakayama, Japan.
TEL	073-441-0751
Email	mhotomi@wakayama-med.ac.jp

Public contact
Name of contact person	Muneki Hotomi
Organization	Wakayama Medical University
Division name	Otolaryngology-Head and Neck Surgery
Address	811-1 Kimiidera Wakayama-shi, Wakayama, Japan.
TEL	073-441-0751
Homepage URL
Email	mhotomi@wakayama-med.ac.jp

Sponsor
Institute	Otolaryngology-Head and Neck Surgery, Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012797