Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Public ClinicalTrials.gov record NCT00369824. 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 Randomized, Open Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine Co-administered Intramuscularly With Boostrix® and/or Menactra™ in Healthy Female Subjects Aged 11-18 Years
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. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study identification
- NCT ID
- NCT00369824
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,330 participants
Conditions and interventions
Conditions
Interventions
- Different formulations of GSK Biologicals' HPV vaccine (580299) Biological
- Menactra TM Biological
- Boostrix TM Biological
Biological
Eligibility (public fields only)
- Age range
- 11 Years to 18 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
- Sep 26, 2006 (Type not available)
- Primary completion
- Nov 22, 2007 (Actual)
- Completion
- Feb 13, 2008 (Actual)
- Last update posted
- Jul 20, 2018
2006 – 2008
United States locations
- U.S. sites
- 50
- U.S. states
- 24
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | — |
| GSK Investigational Site | Chandler | Arizona | 85224 | — |
| GSK Investigational Site | Mesa | Arizona | 85203 | — |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Fountain Valley | California | 92708 | — |
| GSK Investigational Site | Fresno | California | 93720 | — |
| GSK Investigational Site | Long Beach | California | 90806 | — |
| GSK Investigational Site | Madera | California | 93637 | — |
| GSK Investigational Site | Rolling Hills Estates | California | 90274 | — |
| GSK Investigational Site | Centennial | Colorado | 80112 | — |
| GSK Investigational Site | Golden | Colorado | 80401 | — |
| GSK Investigational Site | Thornton | Colorado | 80233 | — |
| GSK Investigational Site | Cocoa Beach | Florida | 32931 | — |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | — |
| GSK Investigational Site | Marietta | Georgia | 30062 | — |
| GSK Investigational Site | Arkansas City | Kansas | 67005 | — |
| GSK Investigational Site | Lenexa | Kansas | 66219 | — |
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Lexington | Kentucky | 40503 | — |
| GSK Investigational Site | Louisville | Kentucky | 40202 | — |
| GSK Investigational Site | Bossier City | Louisiana | 71111 | — |
| GSK Investigational Site | Milford | Massachusetts | 01757 | — |
| GSK Investigational Site | Niles | Michigan | 49120 | — |
| GSK Investigational Site | Stevensville | Michigan | 49127 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Edison | New Jersey | 08817 | — |
| GSK Investigational Site | Whitehouse Station | New Jersey | 08889 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87131 | — |
| GSK Investigational Site | Rochester | New York | 14620 | — |
| GSK Investigational Site | Cary | North Carolina | 27518 | — |
| GSK Investigational Site | Laurinburg | North Carolina | 28352 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | — |
| GSK Investigational Site | Sylva | North Carolina | 28779 | — |
| GSK Investigational Site | Akron | Ohio | 44308 | — |
| GSK Investigational Site | Boardman | Ohio | 44512 | — |
| GSK Investigational Site | Cleveland | Ohio | 44118 | — |
| GSK Investigational Site | Portland | Oregon | 97216 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16501 | — |
| GSK Investigational Site | Greenville | Pennsylvania | 16125 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15220 | — |
| GSK Investigational Site | Uniontown | Pennsylvania | 15401 | — |
| GSK Investigational Site | Charleston | South Carolina | 29401 | — |
| GSK Investigational Site | Charleston | South Carolina | 29407 | — |
| GSK Investigational Site | Gray | Tennessee | 37615 | — |
| GSK Investigational Site | San Angelo | Texas | 76904 | — |
| GSK Investigational Site | Burke | Virginia | 22015 | — |
| GSK Investigational Site | Vienna | Virginia | 22180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00369824, 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 Jul 20, 2018 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00369824 live on ClinicalTrials.gov.