Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Overview
- Phase
- Phase 2
- Intervention
- Gardasil
- Conditions
- Vaccine Reaction
- Sponsor
- PharmaJet, Inc.
- Locations
- 1
- Primary Endpoint
- Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
- Status
- Withdrawn
- Last Updated
- last year
Overview
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
1: Intradermal needle-free injection
Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
Intervention: Gardasil
1: Intradermal needle-free injection
Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
Intervention: PharmaJet Tropis® Needle-Free Injection System
2: Intramuscular needle-free injection
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
Intervention: Gardasil
2: Intramuscular needle-free injection
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
Intervention: PharmaJet Stratis® Needle-Free Injection System
3: Needle and syringe
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe
Intervention: Gardasil
Outcomes
Primary Outcomes
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time Frame: Day 0 through Day 210
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® 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
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time Frame: 28 days following each vaccination
Secondary Outcomes
- 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)