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A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
NCT05496231 · View on ClinicalTrials.gov ↗
Study Summary
The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.
Conditions Studied
Interventions
- BIOLOGICAL Gardasil 9
- BIOLOGICAL HPV9 High formulation
- BIOLOGICAL HPV9 Medium formulation
- BIOLOGICAL HPV9 Low formulation
Study Locations (20)
Florida
- GSK Investigational Site — Coral Gables
- GSK Investigational Site — Kissimmee
- GSK Investigational Site — Miami
- GSK Investigational Site — North Miami Beach
- GSK Investigational Site — Pompano Beach
- GSK Investigational Site — Sarasota
California
- GSK Investigational Site — San Diego
- GSK Investigational Site — San Diego
Indiana
- GSK Investigational Site — Evansville
- GSK Investigational Site — South Bend
Kansas
- GSK Investigational Site — Topeka
- GSK Investigational Site — Wichita
Colorado
- GSK Investigational Site — Wheat Ridge
Georgia
- GSK Investigational Site — Atlanta
Kentucky
- GSK Investigational Site — Lexington
Louisiana
- GSK Investigational Site — Covington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,080 participants |
| Start Date | 2022-08-22 |
| Est. Completion | 2024-02-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05496231
The ClinicalTrials.gov registry entry for NCT05496231 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,080 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cervical Intraepithelial Neoplasia appearing as the primary indexed condition, and to 4 interventions — of which Gardasil 9 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05496231 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05496231 about?
NCT05496231 is a clinical study titled "A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age". The main purpose of this study was to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.
What is the current status of trial NCT05496231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,080 participants. The study started on 2022-08-22. Estimated completion is 2024-02-25.
What conditions does trial NCT05496231 study?
This clinical trial studies the following conditions: Cervical Intraepithelial Neoplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05496231?
The interventions under investigation include: Gardasil 9 (BIOLOGICAL), HPV9 High formulation (BIOLOGICAL), HPV9 Medium formulation (BIOLOGICAL), HPV9 Low formulation (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05496231?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05496231 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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