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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT01270503
Eligibility Criteria:
Inclusion Criteria:
* Aged 2 to 11 years of age on the day of inclusion (Group 1)
* Aged 12 to 17 years of age on the day of inclusion (Group 2)
* Aged 18 to 55 years of age on the day of inclusion (Group 3)
* Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
* Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
* Provision of informed consent form signed by the subject (Group 3)
* If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
* Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
* For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).
Exclusion Criteria:
* For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
* Breast-feeding woman
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine during the present trial period
* Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
* History of seizures
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
* Personal of family history of Guillain-Barré Syndrome.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
55 Years
Study:
NCT01270503
Study Brief:
Protocol Section:
NCT01270503