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

NCT06142461 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-24

No results posted yet for this study

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

Conditions

  • Vaccine Reaction

Interventions

DRUG

Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume

DRUG

Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume

DRUG

Gardasil

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume

DEVICE

PharmaJet Stratis® Needle-Free Injection System

0.5mL dose injection

DEVICE

PharmaJet Tropis® Needle-Free Injection System

0.1mL dose injection

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Cancer Institute (NCI)

    collaborator NIH

  • PharmaJet, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
13 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-12-30
Completion
2025-04-30

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06142461 on ClinicalTrials.gov