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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01375933
Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.
Exclusion Criteria:
* Prior exposure to NicVAX or any other nicotine vaccine.
* History of clinically significant allergic reactions.
* Use of systemic steroids.
* Cancer or cancer treatment within 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence.
* Required treatment for depression within the past 12 months.
* Body mass index ≥ 30 \[calculated as weight (kg)/height2 (m)\].
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 30 weeks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01375933
Study Brief:
Protocol Section:
NCT01375933