Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05496231 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Cervical Intraepithelial Neoplasia, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,080
- Enrollment target
- 20
- Study locations
NCT05496231: Completed Phase 1 study of Cervical Intraepithelial Neoplasia, sponsored by GlaxoSmithKline.
NCT05496231 is a Phase 1 study of Cervical Intraepithelial Neoplasia that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,080 participants, above the 91-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (1087% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05496231, a Phase 1 study of Cervical Intraepithelial Neoplasia, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,080 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Assessed solicited administration site events included pain, redness and swelling at injection site. Grade 3 pain = significant pain at rest, which prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling with a surface diameter greater than (\>) 50 millimeters (mm).
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 |
What the finished NCT05496231 record still lists
NCT05496231 is an interventional study that assigns participants to a tested intervention. Its 1,080 participants enrollment target places it among the larger protocols in the corpus, above the 91-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (1087% higher).
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.
NCT05496231 names 20 study sites across 12 states, led by Florida, California, Indiana.
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.
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).
Who is sponsoring clinical trial NCT05496231?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Cervical Intraepithelial Neoplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Fenofibrate in Patients With Cervical Intraepithelial Neoplasia and Invasive Cervical Carcinoma
RECRUITING · Phase 1
-
Pembrolizumab for the Treatment of Cervical Intraepithelial Neoplasia
RECRUITING · Phase 2
-
Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
RECRUITING · Phase 4
-
A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings
ACTIVE NOT RECRUITING · NA
-
Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
COMPLETED · Phase 2
-
A Clinical Trial of PepCan to Two Therapy Arms for Treating Cervical High-Grade Squamous Intraepithelial Lesions
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06074068 · 1,080 participants · NA
Father-Focused Intervention for Reducing Family Violence and Symptoms in Children
- NCT07213804 · 1,080 participants · Phase 3
A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
- NCT07084883 · 1,076 participants
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
- NCT06658808 · 1,075 participants · NA
Efficacy-Implementation Study for PC CARES in Rural Alaska
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI