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NCT06142461 | WITHDRAWN | Vaccine Reaction

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

Condition or disease

Vaccine Reaction

Intervention/treatment

Gardasil

Gardasil

Gardasil

PharmaJet Stratis® Needle-Free Injection System

PharmaJet Tropis® Needle-Free Injection System

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 0 participants
Masking : SINGLE
Masking Description : Open-label vaccination. Serology samples for immunogenicity assessment are blinded.
Primary Purpose : PREVENTION
Official Title : Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
Actual Study Start Date : 2024-05-31
Estimated Primary Completion Date : 2024-12-30
Estimated Study Completion Date : 2025-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 13 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
  • * Any condition that may interfere with ability to comply with trial procedures, as assessed by the Investigator.
Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

Location Details

NCT06142461

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How to Participate

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Locations

Not yet recruiting

Indonesia,

Padjadjaran University

Bandung, Indonesia,