Change in landscape of HPV treatment

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

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.

Open-label vaccination. Serology samples for immunogenicity assessment are blinded.