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:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT01582633
Eligibility Criteria:
Inclusion Criteria:
* Between 42 and up to 60 years of age.
* Available for follow up visits, at least at day 21.
* Written informed consent signed by the volunteer after reading and explanation.
Exclusion Criteria:
* Suspect or verified diagnosis of congenital or acquired immunodeficiency including AIDS.
* Suspect or verified diagnosis of malignant neoplasia, other than basocellular carcinoma.
* Volunteer ongoing treatment with high doses of systemic corticosteroids (equivalent to prednisone (2 mg/kg/d for more than two weeks) or on immunosuppressant therapy.
* Received or planning to receive a vaccine with live attenuated strain of virus within 30 days of the intended day(s) of study vaccination(s).
* Verified diagnosis of Influenza A/California/H1N1 or has already been immunized against (Influenza A/California/H1N1).
* Suspect or confirmed pregnancy (no need of pregnancy test, information on possible pregnancy is enough. These cases must be referred to routine vaccination).
* Suspect or verified diagnosis of hypersensitivity to any ingredient of the vaccine, to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine.
* Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
* Volunteer shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events following immunization at the research team's discretion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
42 Years
Maximum Age:
60 Years
Study:
NCT01582633
Study Brief:
Protocol Section:
NCT01582633