Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
Public ClinicalTrials.gov record NCT00423046. 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
Phase IIIb, Observer-blind Study to Compare Immunogenicity of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Versus Gardasil® [Quadrivalent Human Papillomavirus (HPV-6,11,16,18 L1 VLP) Recombinant Vaccine Merck & Co., Inc.]
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in \> 70%, approximately, of all cervical cancers. Recently, Merck's HPV vaccine Gardasil® \[quadrivalent human papillomavirus (HPV-6,11,16,18 L1 VLP) recombinant vaccine\] has been approved by the FDA for prevention of genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV vaccine and Gardasil® have different compositions and are expected to have different efficacy profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted. This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18) to Gardasil® in healthy adult females 18-45 years of age. The Protocol Posting has been updated as the study will be extended by 3 additional years.
Study identification
- NCT ID
- NCT00423046
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,106 participants
Conditions and interventions
Interventions
- GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) Biological
- Gardasil ® (Merck & Co. Inc) Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 45 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 24, 2007 (Actual)
- Primary completion
- Mar 7, 2008 (Actual)
- Completion
- May 14, 2012 (Actual)
- Last update posted
- Jan 2, 2020
2007 – 2012
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | 85224 | — |
| GSK Investigational Site | San Diego | California | 92123 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | Vista | California | 92083 | — |
| GSK Investigational Site | West Covina | California | 91790 | — |
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Louisville | Colorado | 80027 | — |
| GSK Investigational Site | Boynton Beach | Florida | 33437 | — |
| GSK Investigational Site | Coral Gables | Florida | 33134 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Boise | Idaho | 83642 | — |
| GSK Investigational Site | Arkansas City | Kansas | 67005 | — |
| GSK Investigational Site | Wichita | Kansas | 67207 | — |
| GSK Investigational Site | Bardstown | Kentucky | 40004 | — |
| GSK Investigational Site | Milford | Massachusetts | 01757 | — |
| GSK Investigational Site | Stevensville | Michigan | 49127 | — |
| GSK Investigational Site | Chaska | Minnesota | 55318 | — |
| GSK Investigational Site | Saint Paul | Minnesota | 55108 | — |
| GSK Investigational Site | Omaha | Nebraska | 68131 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | The Bronx | New York | 10461 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27514 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45249 | — |
| GSK Investigational Site | Cleveland | Ohio | 44122 | — |
| GSK Investigational Site | Willoughby Hills | Ohio | 44094 | — |
| GSK Investigational Site | Carnegie | Pennsylvania | 15106 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16507 | — |
| GSK Investigational Site | Erie | Pennsylvania | 16508 | — |
| GSK Investigational Site | Lancaster | Pennsylvania | 17601 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Upper Saint Clair | Pennsylvania | 15241 | — |
| GSK Investigational Site | Warwick | Rhode Island | 02886 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | — |
| GSK Investigational Site | Tacoma | Washington | 98418 | — |
| GSK Investigational Site | Walla Walla | Washington | 99362 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00423046, 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 Jan 2, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00423046 live on ClinicalTrials.gov.