Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components

Immunogenicity and cross-immunity after booster immunization with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components - A non-blind phase 4 clinical trial with adjuvanted whole virion A (H5N1) vaccine of Qinghai strain Part2 Immunization effect on adults who might be exposed to H5N1 viral components (H5N1_QB2)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000004788

Enrollment

300

Registered

2010-12-24

Start date

2010-12-01

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 participated in manufacturing influenza A (H5N1) vaccine in the institutes according to the 2010 MHLW contract 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Measurement of neutralizing antibody to Qinghai strain, if possible Vietnam, Indonesia and Anhui strain	—

Countries

Japan

Outcome results