drugset / Trial / NCT06142461
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Phase 2
Withdrawn
PharmaJet, Inc.
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupSingle-blindPrevention
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
Timeline
- Start
- 2024-05-31
- Primary completion
- 2024-12-30
- Completion
- 2025-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gardasil | Vaccine | 0.2 ml | Intramuscular |
| Subject | Gardasil | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.