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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT00444860
Eligibility Criteria:
Inclusion Criteria:
* Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
* All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
* Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
* A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
* Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
* Subject Must Sign Informed Consent Prior To Any Study Procedure
* Subject Must Be afebrile (\<38.3 °C Oral) On Day Of Vaccination
* Any Underlying Chronic Illness Must Be In Stable Condition
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00444860
Study Brief:
Protocol Section:
NCT00444860