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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Universitas Padjadjaran
Bandung, Indonesia
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time frame: Day 0 through Day 210
Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time frame: 28 days following each vaccination
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time frame: Day 0 through Day 210
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time frame: 28 days following each vaccination
Non-inferior immunogenicity of intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe
Time frame: 28 days following each vaccination
Non-inferior immunogenicity of intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System compared to full dose intramuscular administration of Gardasil using needle and syringe
Time frame: 28 days following each vaccination
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0.5mL dose injection
0.1mL dose injection