UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006132
Receipt number R000007253
Scientific Title The Comparison of serotype-specific IgG and OPK activity between PCV7 and PPV23 among elderly patients
Date of disclosure of the study information 2011/08/12
Last modified on 2011/08/09 00:28:02

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Basic information

Public title

The Comparison of serotype-specific IgG and OPK activity between PCV7 and PPV23 among elderly patients

Acronym

The Comparison of immunogenecity between PCV7 and PPV23 among elderly patients

Scientific Title

The Comparison of serotype-specific IgG and OPK activity between PCV7 and PPV23 among elderly patients

Scientific Title:Acronym

The Comparison of immunogenecity between PCV7 and PPV23 among elderly patients

Region

Japan


Condition

Condition

non

Classification by specialty

Pneumology Infectious disease Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to cmpare the immunogenicity of PCV7 and PPV 23

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

serotype-specific IgG and OPK activity after 1 month

Key secondary outcomes

serotype-specific IgG and OPK activity from 1 year to 5 years
incident ratio of pneumoniae, moribidity due to pneumonaie, total morbidity up to 5 years


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

PCV7(Prevenar®)

Interventions/Control_2

PPV23(Pneumovax®)

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

65 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1)written informed consent obtained from the subject.
2)healthy adults aged 65 years or older at time of the first vaccination.

Key exclusion criteria

1)history of previous administration of PCV7 or PPV23.
2)history of anaphlractic reaction to diphtheria toxin.
3)dementia patinets.
4)patients who we are not able to follow up more than 1 month.
5)patients with fever or flu-like syndrome.
6)patients who we consider inappropriate.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Hasegawa

Organization

Keio University School of Medicine

Division name

Centor for Infectious Disease and Infection Control

Zip code


Address

Shinanomachi 35 Shinjyuku-ku Tokyo

TEL

03-3353-1211

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ho Namkoong

Organization

Keio University School of Medicine

Division name

Department of Medicine Division of Pulmonary Medicine

Zip code


Address

Shinanomachi 35 Shinjyuku-ku Tokyo

TEL

03-3353-1211

Homepage URL


Email

hounamugun@gmail.com


Sponsor or person

Institute

Keio University School of Medicine Centor for Infectious Disease and Infection Control

Institute

Department

Personal name



Funding Source

Organization

Pfizer Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Kitasato Institute Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

慶應義塾大学医学部(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 08 Month 12 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

Open public recruiting

Date of protocol fixation

2011 Year 08 Month 10 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 08 Month 09 Day

Last modified on

2011 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name