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

Study Overview
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Brief Summary
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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

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

Conditions
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Vaccine Reaction

Intervention / Treatment
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* Drug: Gardasil
* Drug: Gardasil
* Drug: Gardasil
* Device: PharmaJet Stratis® Needle-Free Injection System
* Device: PharmaJet Tropis® Needle-Free Injection System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between the age of 12 years and 13 years, inclusive. (Female 7th grade junior high school students in Indonesia) Clinically healthy, as established by medical history and physical examination before entering the study. Not pregnant at the time of vaccination. Able to provide informed consent and assent. Able to comply with the study. Exclusion Criteria: Previous vaccination against HPV. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days prior to study enrollment, or planned use during the study period. Administration of any vaccine within 30 days prior the study enrollment, or within 30 days of study vaccination visits. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study enrollment, or planned use during the study period. Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. History of allergic disease, suspected allergy, or reactions likely to be exacerbated by any component of vaccine, including yeast. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, autoimmune disease. Participants with medically stable, well controlled autoimmune disease may be permitted. Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection. Received immunoglobulins and/or blood product within 90 days preceding enrollment, or planned use during the study period. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C. Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: Intradermal needle-free injection<br>Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System. | Drug: Gardasil<br>* Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume<br>* Other names: Gardasil vial, 0.2mL;Device: PharmaJet Tropis® Needle-Free Injection System<br>* 0.1mL dose injection<br>* Other names: Tropis;|
| Experimental: 2: Intramuscular needle-free injection<br>Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System | Drug: Gardasil<br>* Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume<br>* Other names: Gardasil vial, 0.5mL;Device: PharmaJet Stratis® Needle-Free Injection System<br>* 0.5mL dose injection<br>* Other names: Stratis;|
| Active Comparator: 3: Needle and syringe<br>Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe | Drug: Gardasil<br>* Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume<br>* Other names: Gardasil PFS, 0.5mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System |  | Day 0 through Day 210 | 
| Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System |  | 28 days following each vaccination | 
| Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System |  | Day 0 through Day 210 | 
| Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System |  | 28 days following each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 28 days following each vaccination |