UMIN-CTR Clinical Trial

Public title

Cross immunity effect of the influenza A (H5N1) vaccine

Acronym

Cross immunity effect of the influenza A (H5N1) vaccine

Scientific Title

Cross immunity effect of the influenza A (H5N1) vaccine

Scientific Title:Acronym

Cross immunity effect of the influenza A (H5N1) vaccine

Region

Japan

Condition

Prevention of influenza

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the immunologic memory effect and cross immunity of the two-dose of adjuvanted influenza A (H5N1) vaccination of Indonesia strain on the adult healthy volunteers, either 60days or 90days later, immunogenicity is examine after single administration of H5N1 vaccine of another strains which are simulated as pandemic strains.

Basic objectives2

Pharmacodynamics

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Measurement of neutralizing antibody to influenza A(H5N1)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the two-dose of adjuvanted influenza A (H5N1) vaccine of Indonesia strain, 60days later, single administration of H5N1 vaccine of Vietnam strain which are simulated as pandemic strains.

Interventions/Control_2

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the two-dose of adjuvanted influenza A (H5N1) vaccine of Indonesia strain, 60days later, single administration of H5N1 vaccine of Qinghai strain which are simulated as pandemic strains.

Interventions/Control_3

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the two-dose of adjuvanted influenza A (H5N1) vaccine of Indonesia strain, 90days later, single administration of H5N1 vaccine of Vietnam strain which are simulated as pandemic strains.

Interventions/Control_4

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the two-dose of adjuvanted influenza A (H5N1) vaccine of Indonesia strain, 90days later, single administration of H5N1 vaccine of Qinghai strain which are simulated as pandemic strains.

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 have not been vaccinated with influenza A (H5N1) vaccine

2)Individuals, who could be follow up survey for five years after inoculation

3)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 Avian Influenza A (H5N1) virus infection. (obtained from 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 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 (including the day 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 (including the day of vaccination).

8)Individuals who are deemed to be inappropriate by the investigator

Target sample size

200

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

059-232-2531

Email

ihara@mie-m.hosp.go.jp

Name of contact person

1st name
Middle name
Last name	Suminobu Ito

Organization

Clinical Research Center, National Hospital Organization

Division name

Clinical trial promotion office,

Zip code

Address

2-5-21 Higashigaoka,Meguro-ku,Toukyo

TEL

03-5712-5087

Homepage URL

Email

chiken@nho.hosp.go.jp

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

国立病院機構栃木医療センター　NHO Tochigi Medical Center
国立病院機構三重病院 NHO Mie National Hospital
国立病院機構南京都病院 NHO Minami Kyoto Hospital
国立病院機構南和歌山医療センター NHO Minami Wakayama Medical Center
国立病院機構高知病院 NHO Kochi National Hospital
国立病院機構南岡山医療センター NHO Miami-Okayama Medical Center
国立病院機構長崎医療センター NHO Nagasaki Medical Center

Date of disclosure of the study information

2014

Year

11

Month

12

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

2014

Year

11

Month

07

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

12

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=R000018221