Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT00660257
Eligibility Criteria:
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 anti-TB prophylaxis or therapy currently
* Axillary temperature \>37.0 centigrade at the time of dosing
* Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
61 Years
Study:
NCT00660257
Study Brief:
Protocol Section:
NCT00660257