Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142461
Status:
WITHDRAWN
Last Update Posted:
2024-05-24
First Post:
2023-11-16
Brief Title:
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Sponsor:
PharmaJet Inc
Organization:
PharmaJet Inc
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WITHDRAWN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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R44CA261326-01A1 | NIH | None | httpsreporternihgovquickSearch1R44CA261326-01A1 |