A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inacti… (NCT01675284) | Clinical Trial Compass
CompletedPhase 1
A Phase I Study to Evaluate the Safety, Reactogenicity, and Humoral Immune Responses to an Inactivated H5N1 Influenza Vaccine
Taiwan36 participantsStarted 2012-08
Plain-language summary
The focus of this study is to evaluate the safety, reactogenicity and humoral immune responses of the study vaccine when administered at the dose of 7.5 µg HA, 15 µg HA, or 30 µg HA to human subjects.
Who can participate
Age range20 Years – 60 Years
SexALL
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Inclusion Criteria:
* Male or female ≥20 and ≤60 years of age
* In good health as determined by medical history, physical examination, and clinical judgment of the investigator
* Willing and able to comply with all required study visits and follow-up required by this protocol
* Must provide written informed consent
Exclusion Criteria:
* Known or potential exposure to avian influenza virus or any H5N1 HA antigen vaccine
* Had any influenza vaccine within 6 months
* Administered with any vaccine within 30 days
* A history of hypersensitivity to vaccines or inflammatory or degenerative neurological disease
* Receiving chronic administration of immunosuppressants or other immune-modifying drugs within 6 months
* Known HIV, hepatitis B (HBsAg) or hepatitis C seropositivity
* Any medical illness including clinically significant acute pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
* Receiving immunoglobulins and/or any blood products within the three months
* Acute disease at the time of enrolment
* Psychiatric, addictive, or any disorder, which may compromise the ability to give a truly informed consent for participation of this study or adequate compliance
* Breast feeding or pregnant women
What they're measuring
1
Signs and symptoms solicited by vaccination
Timeframe: A 7-day follow-up period after each vaccine administration
2
Signs and symptoms unsolicited by vaccination
Timeframe: A 21-day follow-up period after each vaccine administration
3
Occurrence of adverse events and serious adverse events
Timeframe: Up to 180 days after the first vaccine administration