UMIN-CTR Clinical Trial

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

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Clinical Research Center,
National Hospital Organization

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2010

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 related 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