Safety of the pandemic influenza A (H5N1) vaccination of Egyptian stain on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza might be spread.

Safety of the pandemic influenza A (H5N1) vaccination of Egyptian stain on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza might be spread. - Safety of the Influenza A (H5N1) vaccination on 1,000 healthy volunteers (H5N1_Egypt safety)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011816

Enrollment

1000

Registered

2013-09-19

Start date

2013-09-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of influenza

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Survey for safety from first administration influenza A (H5N1) vaccine to last administration influenza A (H5N1) vaccine after 28days.	—

Secondary

Measure	Time frame
Effectiveness of the vaccine might be evaluated based on the incidence of influenza like illness, when H5N1 type influenza is spread within five years.	—

Countries

Japan

Contacts

Public ContactSuminobu Ito

Clinical Research Center, National Hospital Organization Clinical trial promotion office, Clinical Research Department

chiken@hosp.go.jp03-5712-5087

Outcome results