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NCT00231413 · ClinicalTrials.gov registry record · Phase 2
Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 383
- Enrollment target
NCT00231413: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00231413 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 383 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231413, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 383 participants
- Enrollment target
Study Summary
Human Papilloma viruses (HPV) are viruses that cause infections 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, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
Primary Outcome
Seroconversion was defined as the appearance of anti-HPV-16 antibodies \[i.e. antibody titer greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Interventions
- BIOLOGICAL HPV 16/18 L1 AS04
- BIOLOGICAL HPV-16/18/31/45 L1 AS04 Formulation 1
- BIOLOGICAL HPV-16/18/31/45 L1 AS04 Formulation 2
- BIOLOGICAL HPV-16/18/31/45 L1 AS04 Formulation 3
- BIOLOGICAL HPV-16/18/31/45 L1 AS04 Formulation 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2005-03-04 |
| Est. Completion | 2006-03-27 |
| Phase | Phase 2 |
What the finished NCT00231413 record still lists
NCT00231413 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 5 interventions - of which HPV 16/18 L1 AS04 is the first listed.
NCT00231413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00231413 about?
NCT00231413 is a clinical study titled "Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.". Human Papilloma viruses (HPV) are viruses that cause infections 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, if it persists, can lead over a long period ...
What is the current status of trial NCT00231413?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 383 participants. The study started on 2005-03-04. Estimated completion is 2006-03-27.
What interventions are being tested in trial NCT00231413?
The interventions under investigation include: HPV 16/18 L1 AS04 (BIOLOGICAL), HPV-16/18/31/45 L1 AS04 Formulation 1 (BIOLOGICAL), HPV-16/18/31/45 L1 AS04 Formulation 2 (BIOLOGICAL), HPV-16/18/31/45 L1 AS04 Formulation 3 (BIOLOGICAL), HPV-16/18/31/45 L1 AS04 Formulation 4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00231413?
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 NCT00231413's enrollment target sits among peer trials
383 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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