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NCT00423046 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,106
- Enrollment target
NCT00423046: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00423046 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,106 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00423046, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,106 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Titers are displayed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM)
- BIOLOGICAL Gardasil ® (Merck & Co. Inc)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,106 participants |
| Start Date | 2007-01-24 |
| Est. Completion | 2012-05-14 |
| Phase | Phase 3 |
What the finished NCT00423046 record still lists
NCT00423046 is an interventional study that assigns participants to a tested intervention. Its 1,106 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00423046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00423046 about?
NCT00423046 is a clinical study titled "Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age". 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...
What is the current status of trial NCT00423046?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,106 participants. The study started on 2007-01-24. Estimated completion is 2012-05-14.
What interventions are being tested in trial NCT00423046?
The interventions under investigation include: Placebo (BIOLOGICAL), GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) (BIOLOGICAL), Gardasil ® (Merck & Co. Inc) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00423046?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00423046's enrollment target sits among peer trials
1,106 251st of 2000 higher than 1,750 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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