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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01961960
Eligibility Criteria:
Inclusion Criteria:
* Healthy or medically stable, as judged on the basis of history and concurrent diseases.
* Subject understands procedure of the protocol and is willing to comply with the protocol.
* Written informed consent has been obtained.
Exclusion Criteria:
* Scheduled to receive another vaccine during the study.
* Received influenza HA vaccine within 180 days prior to screening.
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination with the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination with the study vaccine.
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome.
* Received one of the following medications or treatment prior to vaccination with the study vaccine: Interferon formulation, Drugs which affect the immune system, corticosteroids, G-CSF, M-CSF, Human immunoglobulin products, Blood products, Blood transfusion
* History of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* History of seizures, except for febrile seizures in childhood
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
61 Years
Study:
NCT01961960
Study Brief:
Protocol Section:
NCT01961960