Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

Not Applicable

• Conditions: -B977 Papillomavirus as the cause of diseases classified to other chapters; Papillomavirus as the cause of diseases classified to other chapters; B977

• Registration Number: PER-004-06
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 178

Inclusion Criteria

1. A woman who can and will comply with the requirements of the protocol.
2. A woman of at least 26 years of age at the time of the first vaccination.
3. Written informed consent obtained from the subject before being recruited.
4. Be free of obvious health problems.
5. The subject must have an intact cervix.
6. The subject must have a negative urine pregnancy test.
7. The subject should not have potential for maternity / fertility or, if the patient has fertility potential, should practice abstinence or should be using an effective method for birth control for 30 days before the first vaccination and should agree to continue with these precautions for two months after completing the vaccination series.

Exclusion Criteria

1. Pregnancy or lactation.
2. A woman who intends to become pregnant, who is likely to become pregnant or who plans to discontinue contraceptive precautions during the vaccination phase of the study.
3. Use of any investigational or unregistered product other than study vaccines within 30 days prior to the first dose.
4. Chronic administration of immunosuppressants or other medications that modify the immune system in the six months prior to the first dose of vaccine.
5. Administration of a vaccine not foreseen by the study protocol in the 30 days before and after the administration of the first dose of the study vaccine.
6. Previous administration of MPL® or adjuvant AS04.
7. Prevaccination against HPV.
8. History of infection / previous treatment of HPV or treatment to evaluate an abnormal cervical cytology test.
9. Any suspected immunosuppressed or medically diagnosed condition.
10. History of allergic disease, suspected allergy or reactions that are likely to be exacerbated by any component of the study vaccines.
11. Hypersensitivity to latex.
12. Known functional abnormality, acute or chronic, clinically significant, neurological, hepatic or renal.
13. History of chronic conditions that require treatment.
14. Administration of immunoglobulins and / or any blood product in the three months prior to the first dose of the study vaccine, or its planned administration during the study period.
15. Acute disease at the time of recruitment.
16. Considerable bleeding or significant vaginal discharge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified