UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004169
Receipt number R000005006
Scientific Title Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain
Date of disclosure of the study information 2010/09/07
Last modified on 2016/02/24 11:01:37

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Basic information

Public title

Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain

Acronym

A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain

Scientific Title

Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain

Scientific Title:Acronym

A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain

Region

Japan


Condition

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1) Evaluation of immunogenicity and cross-immunity after immunization with the heterologous strain to the individuals, who were vaccinated with the different strain in 2008
2) Evaluation of immunogenicity, cross-immunity and safety after immunization with the homorologous strain to the individuals, who were vaccinated twice with adjuvanted influenza A (H5N1) vaccine 6 months ago

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of neutralizing antibody to Qinghai, Vietnam, Indonesia and Anhui strain

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

Evaluate immunogenicity and safety after immunization with adjuvanted influenza A (H5N1) vaccine of Qinghai strain to the individuals, who had vaccinated twice with Indonesia strain or Anhui strain in 2008

Interventions/Control_2

Evaluate immunogenicity and safety after two-dose of adjuvanted influenza A (H5N1) vaccine of Qinghai strain and after boosting with Qinghai strain to the individuals, who could be vaccinated twice with Qinghai strain 6 months ago

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Individuals, who had been vaccinated twice with adjuvanted influenza A (H5N1) vaccine of Indonesia strain or Anhui strain in 2008 or individuals, who have not been vaccinated with influenza A (H5N1) vaccine
2)Individuals, who could be followed under the regulation of the clinical trial, could be examined according to the protocol, and could report their symptoms.

Key exclusion criteria

1) Individuals with the history of Swine Influenza A (H5N1) virus infection. (obtained by subjects)
2) Individuals, who had history of anaphylaxis to foods or medicines previously.
3) Individuals with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
4) Individuals with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
5) Individuals participated in a clinical trial with influenza vaccine within four months (counted from the date of vaccination).
6) Individuals vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (counting from the date of vaccination).
7) Individuals received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg / kg or more) within six months (counting from the date of vaccination).

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Ihara

Organization

National Hospital Organization Mie National Hospital

Division name

Director

Zip code


Address

357 Ozato-Kubota, Tsu, Mie

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Clinical Research Center, National Hospital Organization Headquarters

Division name

Clinical trial promotion office

Zip code


Address


TEL

03-5712-5075

Homepage URL


Email



Sponsor or person

Institute

Clinical Research Center,
National Hospital Organization

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 07 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2010 Year 08 Month 27 Day

Date of IRB


Anticipated trial start date

2010 Year 09 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

2010 Year 09 Month 07 Day

Last modified on

2016 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005006


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name