Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Public ClinicalTrials.gov record NCT00122681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 study subjects will either receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study identification
- NCT ID
- NCT00122681
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 18,729 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 15 Years to 25 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 5, 2004
- Primary completion
- Nov 2, 2006
- Completion
- Nov 25, 2009
- Last update posted
- Aug 19, 2018
2004 – 2009
United States locations
- U.S. sites
- 50
- U.S. states
- 24
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35233 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | San Diego | California | 92108 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | Boulder | Colorado | 80303 | — |
| GSK Investigational Site | Boulder | Colorado | 80304 | — |
| GSK Investigational Site | Denver | Colorado | 80218 | — |
| GSK Investigational Site | Louisville | Colorado | 80027 | — |
| GSK Investigational Site | Clearwater | Florida | 33759 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | — |
| GSK Investigational Site | Augusta | Georgia | 30912 | — |
| GSK Investigational Site | Honolulu | Hawaii | 96826 | — |
| GSK Investigational Site | Iowa City | Iowa | 52242 | — |
| GSK Investigational Site | Arkansas City | Kansas | 67005 | — |
| GSK Investigational Site | Wichita | Kansas | 67205 | — |
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | — |
| GSK Investigational Site | Omaha | Nebraska | 68131 | — |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | — |
| GSK Investigational Site | Morristown | New Jersey | 07960 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87131 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | Poughkeepsie | New York | 12601 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | — |
| GSK Investigational Site | New Bern | North Carolina | 28562 | — |
| GSK Investigational Site | Cleveland | Ohio | 44109 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74105 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16502 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16505 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16507 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19114 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15236 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Webster | Texas | 77598 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84120 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | — |
| GSK Investigational Site | Spokane | Washington | 99202 | — |
| GSK Investigational Site | Spokane | Washington | 99218 | — |
| GSK Investigational Site | Vancouver | Washington | 98664 | — |
| GSK Investigational Site | Wenatchee | Washington | 98801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 88 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00122681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 19, 2018 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00122681 live on ClinicalTrials.gov.