Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Infl… (NCT00660257) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine
China57 participantsStarted 2007-01
Plain-language summary
A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).
Who can participate
Age range19 Years – 61 Years
SexALL
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Inclusion Criteria:
* Had received two-dose priming vaccination in previous phase I trial
* Be able to show legal identity card for the sake of recruitment
* Be able to understand and sign the informed consent.
Exclusion Criteria:
* Woman: Who breast-feeding or planning to become pregnant during the study
* Any history of allergic reactions to vaccines or eggs
* Autoimmune disease or immunodeficiency
* Diabetes mellitus (type I or II), with the exception of gestational diabetes
* Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
* Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
* Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
* Guillain-Barre Syndrome
* Women subjects with positive urinary pregnancy test
* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months
* History of any blood products administration within 3 months before the dosing
* Administration of any other investigational research agents within 30 days before the dosing
* Administration of any live attenuated vaccine within 30 days before the dosing
* Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
* Be receiving …