Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Public ClinicalTrials.gov record NCT00231413. 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 Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00231413
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 383 participants
Conditions and interventions
Conditions
Interventions
- 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
- HPV-16/18/31/45 L1 AS04 Formulation 5 Biological
- HPV-16/18/31/45 L1 AS04 Formulation 6 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 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
- Mar 3, 2005
- Primary completion
- Mar 26, 2006
- Completion
- Mar 26, 2006
- Last update posted
- Dec 11, 2019
2005 – 2006
United States locations
- U.S. sites
- 5
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Golden | Colorado | 80401 | — |
| GSK Investigational Site | Kingston | Rhode Island | 02881 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84109 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84121 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00231413, 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 Dec 11, 2019 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00231413 live on ClinicalTrials.gov.