Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Phase 2
Withdrawn
- Conditions
- Vaccine Reaction
- Interventions
- Device: PharmaJet Tropis® Needle-Free Injection SystemDevice: PharmaJet Stratis® Needle-Free Injection System
- Registration Number
- NCT06142461
- Lead Sponsor
- PharmaJet, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1: Intradermal needle-free injection Gardasil Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System. 3: Needle and syringe Gardasil Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe 1: Intradermal needle-free injection PharmaJet Tropis® Needle-Free Injection System Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System. 2: Intramuscular needle-free injection Gardasil Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System 2: Intramuscular needle-free injection PharmaJet Stratis® Needle-Free Injection System Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
- Primary Outcome Measures
Name Time Method Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System Day 0 through Day 210 Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® 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 Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System 28 days following each vaccination
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Universitas Padjadjaran
🇮🇩Bandung, Indonesia