Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine

Not Applicable

• Conditions: Prevention of influenza

• Registration Number: JPRN-UMIN000002943
• Lead Sponsor: ational Hospital Organization Headquarters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1)Subjects aged 20 years or older at the time of getting informed consent.
2)Pregnant women were permitted after permission by obstetricians or gynecologists.
3)Subjects, who were able to follow the regulation of the trial, have clinical examination written in the protocol and report their symptoms.

Exclusion Criteria

1)Subjects with the history of Swine Influenza A (H1N1) infection. (obtained by subjects)
2)Subjects vaccinated with Swine Influenza A (H1N1) vaccine previously (obtained by subjects).
3)Subjects, who had history of anaphylaxy to foods or medicines previously.
4)Subjects with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
5)Subjects with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
6)Subjects aged 75 years or older living alone, or suffered from dementia and unable to have their consent.
7)Subjects participated in a clinical trial with influenza vaccine within four months (counted from the date of vaccination).
8)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (counting from the date of vaccination).
9)Subjects 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum antibody titers were measured prior to the first injection and the second injection (21plus-minus7days starting with the first injection) and 21 days after the second dose(neutralizing antibody and HI antibody against influenza A (H1N1) 2009 and anti-ganglioside antibodies)