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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00128661 |
Purpose
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer form forming, growing, or coming back. Vaccines may help the body build an effective immune response against human papillomavirus and may be effective in preventing cervical intraepithelial neoplasia or cervical cancer. It is not yet known whether human papillomavirus vaccine is more effective than hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer.
PURPOSE: This randomized phase III trial is studying human papillomavirus vaccine to see how well it works compared to hepatitis A vaccine in preventing cervical intraepithelial neoplasia or cervical cancer in younger healthy participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Precancerous Condition |
Biological: human papillomavirus 16/18 L1 virus-like particle/AS04 vaccine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Double-Blind, Controlled, Randomized, Phase III Study of the Efficacy of an HPV16/18 VLP Vaccine in the Prevention of Advanced Cervical Intraepithelial Neoplasia (CIN2, CIN3, Adenocarcinoma In Situ [AIS] and Invasive Cervical Cancer) Associated With HPV 16 or HPV 18 Cervical Infection in Healthy Young Adult Women in Costa Rica |
| Estimated Enrollment: | 7500 |
| Study Start Date: | June 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, double-blind, parallel-group study. Participants are randomized to 1 of 2 treatment arms.
After completion of study treatment, participants are followed at 6 months and then at least annually for 3 years.
PROJECTED ACCRUAL: Approximately 7,500 participants will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Healthy participants
Resident of Guanacaste Province of Costa Rica and surrounding areas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunology
Other
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| Costa Rica | |
| Proyecto Epidemiologico Guanacaste | |
| Liberia, Costa Rica | |
| Study Chair: | Rolando Herrero, MD | Proyecto Epidemiologico Guanacaste |
| Principal Investigator: | Allan Hildesheim, PhD | National Cancer Institute (NCI) |
More Information
| ClinicalTrials.gov Identifier: | NCT00128661 History of Changes |
| Obsolete Identifiers: | NCT00344357 |
| Other Study ID Numbers: | CDR0000441189, NCI-04-C-N191, NCI-590299/009, GSK-590299/009 |
| Study First Received: | August 8, 2005 |
| Last Updated: | November 1, 2011 |
| Health Authority: | United States: Federal Government |
|
cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 |
|
Neoplasms Uterine Cervical Neoplasms Disease Precancerous Conditions Cervical Intraepithelial Neoplasia Carcinoma in Situ Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Pathologic Processes Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |