UMIN-CTR Clinical Trial

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

Nasopharyngeal carriage

Classification by specialty

Pediatrics

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

mhotomi@wakayama-med.ac.jp

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

Email

mhotomi@wakayama-med.ac.jp

Institute

Otolaryngology-Head and Neck Surgery, Wakayama Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Niigata welfare Federation of Agricultural Cooperative Associations, the Federation of Agricultural Cooperative Unions Sado general hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

和歌山県立医科大学（和歌山県）

Date of disclosure of the study information

2013

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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