Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-01-01 @ 1:44 PM
Study NCT ID:
NCT06142461
Status:
WITHDRAWN
Last Update Posted:
2024-05-24
First Post:
2023-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Sponsor:
PharmaJet, Inc.
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Status:
WITHDRAWN
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in landscape of HPV treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and immunogenicity of an HPV Vaccine (Gardasil) delivered by intramuscular needle-free injection and intradermal needle-free injection. The main question it aims to answer is:
* Is intramuscular and intradermal needle-free injection of Gardasil safe?
* Does intramuscular and intradermal needle-free vaccination with Gardasil illicit an immune response?
Participants will:
* Receive Gardasil by intramuscular needle-free injection, intradermal needle-free injection, or needle and syringe injection.
* Provide blood samples
* Complete physical exams
* Complete diaries
* Is intramuscular and intradermal needle-free injection of Gardasil safe?
* Does intramuscular and intradermal needle-free vaccination with Gardasil illicit an immune response?
Participants will:
* Receive Gardasil by intramuscular needle-free injection, intradermal needle-free injection, or needle and syringe injection.
* Provide blood samples
* Complete physical exams
* Complete diaries
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44CA261326-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |