Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
15–25
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
A subject whom the investigator believes that she can and will comply with the requirements of the protocol
Must have received three doses of study vaccine or placebo control in study 580299/001.
Must have completed study 580299/007.
Written informed consent must be obtained from the subject prior to enrollment in the study.
Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
Subject must have a negative urine pregnancy test.
Subject must be at least three months post-termination of a pregnancy.
Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.
You may not be if
Pregnant or breastfeeding.
A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
previous administration of components of the investigational vaccine outside of protocol 580299/001.
Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
Hypersensitivity to latex
Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Cancer or autoimmune disease under treatment.
Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.
Clareo Health | Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
