NCT06142461

Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: PharmaJet, Inc. · Industry
• Sex: Female
• Age: 12 Years – 13 Years
• Healthy volunteers: Accepted

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

Conditions

• Vaccine Reaction

Interventions

Type	Name	Description
DRUG	Gardasil	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
DRUG	Gardasil	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
DRUG	Gardasil	Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
DEVICE	PharmaJet Stratis® Needle-Free Injection System	0.5mL dose injection
DEVICE	PharmaJet Tropis® Needle-Free Injection System	0.1mL dose injection

Timeline

• Start date: 2024-05-31
• Primary completion: 2024-12-30
• Completion: 2025-04-30
• First posted: 2023-11-21
• Last updated: 2024-05-24

Locations

1 site across 1 country: Indonesia