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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 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.

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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.

Conditions Studied

Cervical Intraepithelial Neoplasia

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

FieldValue
Enrollment Target 1,080 participants
Start Date 2022-08-22
Est. Completion 2024-02-25
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

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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, categorized as Phase 1. The registered enrollment target is 1,080 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 91-participant average among 6 other Cervical Intraepithelial Neoplasia trials with a reported enrollment target (1087% higher). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.