Status:
WITHDRAWN
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Lead Sponsor:
PharmaJet, Inc.
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Vaccine Reaction
Eligibility:
FEMALE
12-13 years
Phase:
PHASE2
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06142461
Start Date
May 31 2024
End Date
April 30 2025
Last Update
May 24 2024
Active Locations (1)
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1
Universitas Padjadjaran
Bandung, Indonesia