Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Open the official record
This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00546078. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study identification
- NCT ID
- NCT00546078
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 116 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
- Jan 14, 2008 (Type not available)
- Primary completion
- Dec 22, 2008 (Actual)
- Completion
- Dec 1, 2009 (Actual)
- Last update posted
- Jun 26, 2018
2008 – 2009
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | San Francisco | California | 94118 | — |
| GSK Investigational Site | Augusta | Georgia | 30912-3500 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87131 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Grove City | Pennsylvania | 16127 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | — |
| GSK Investigational Site | San Antonio | Texas | 78205 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | — |
| GSK Investigational Site | Seattle | Washington | 98105 | — |
| GSK Investigational Site | Marshfield | Wisconsin | 54449 | — |
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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00546078, 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 Jun 26, 2018 · Synced Nov 15, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.