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

May 22, 2024 updated by: PharmaJet, Inc.

Safety and Immunogenicity of Human Papillomavirus Quadrivalent Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Bandung, Indonesia
        • Universitas Padjadjaran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1: Intradermal needle-free injection
Fractional dose (2 x 0.1 mL injections) intradermal administration of Gardasil® using PharmaJet Tropis® Needle-Free Injection System.
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL
Device: PharmaJet Tropis® Needle-Free Injection System
0.1mL dose injection
Other Names:
  • Tropis
Experimental: 2: Intramuscular needle-free injection
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using PharmaJet Stratis® Needle-Free Injection System
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL
Device: PharmaJet Stratis® Needle-Free Injection System
0.5mL dose injection
Other Names:
  • Stratis
Active Comparator: 3: Needle and syringe
Full dose (0.5 mL injection) intramuscular administration of Gardasil® using needle and syringe
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Pre-filled syringe, 0.5mL dose volume
Other Names:
  • Gardasil PFS, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intramuscular injection, 0.5mL dose volume
Other Names:
  • Gardasil vial, 0.5mL
Drug: Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant Needle-free intradermal injection, 0.2mL dose volume
Other Names:
  • Gardasil vial, 0.2mL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time Frame: Day 0 through Day 210
Day 0 through Day 210
Immunogenicity of fractional dose intradermal administration of Gardasil using PharmaJet Tropis® Needle-Free Injection System
Time Frame: 28 days following each vaccination
28 days following each vaccination
Safety of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time Frame: Day 0 through Day 210
Day 0 through Day 210
Immunogenicity of full dose intramuscular administration of Gardasil using PharmaJet Stratis® Needle-Free Injection System
Time Frame: 28 days following each vaccination
28 days following each vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Time Frame: 28 days following each vaccination
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
Time Frame: 28 days following each vaccination
28 days following each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PharmaJet, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPV-PJ-01
  • 1R44CA261326-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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