Efficacy and safety of vaccination of the influenza A (H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination.

Efficacy and safety of vaccination of the influenza A (H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination. - Efficacy and safety of vaccination of the influenza A(H5N1) Egyptian strain, and searching for the optimal intervals of the primary vaccination. (H5N1_Egypt interval)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011799

Enrollment

140

Registered

2013-09-18

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

Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the single-dose of adjuvanted influenza A (H5N1) vaccine of Egyptian strain, 3wee

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
Measurement of neutralizing antibody to influenza A (H5N1)	—

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

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026