Epidemiological studies on human papillomavirus (HPV)

Completed

• Conditions: Human papillomavirus (HPV); Infections and Infestations; Viral agents as the cause of diseases classified to other chapters

• Registration Number: ISRCTN90378590
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

1. Female subjects aged 10-25 years
2. Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study
3. A female between, and including, 10 and 25 years of age at the time of the first vaccination
4. Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment for both the main GSK vaccine trial and for the epidemiological studies on HPV. For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject's parent or legally acceptable representative.
5. Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study.
6. Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0)
7. Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit
8. Subjects must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
9. Subjects must have had no more than 6 sexual partners prior to enrolment
10. Subjects must be willing to undergo HIV voluntary counselling and testing and must be willing to be informed of their HIV status. Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.

Exclusion Criteria

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12)
2. 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
3. Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
4. Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after any dose of study vaccine
5. Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period
6. Previous administration of components of the investigational vaccine
7. Cancer or autoimmune disease under treatment
8. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit
9. Hypersensitivity to latex
10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control
11. Acute disease at the time of enrolment
12. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit
13. History of any neurologic disorders or seizures
14. Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
15. Pregnant or breastfeeding female
16. A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose
17. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)

Study & Design

• Study Type: Observational
• Study Design: Not specified