Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

February 6, 2018 updated by: Vladimir Gilca, Laval University

Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later

This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a one group exploratory study.

The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

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

  • Canada
      • Quebec, Canada, G1E7G9
        • Laval University Research Hospital Center

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

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.

-

Exclusion Criteria: Immunossupressed or blood coagulation problems

-

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gardasil and Gardasil-9
Biological: Gardasil and Gardasil-9
All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HPV seropositivity
Time Frame: One month post vaccine administration.
Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
One month post vaccine administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV antibody titers
Time Frame: One month post vaccine administration
Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed
One month post vaccine administration

Collaborators and Investigators

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

Sponsor

Laval University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Study Chair: Gaston DeSerres, MD, PhD, Quebec Public Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2016

Primary Completion (Actual)

November 5, 2016

Study Completion (Actual)

December 5, 2016

Study Registration Dates

First Submitted

January 26, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CÉ: 2017-3036-21

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

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.

Clinical Trials on Human Papillomavirus Vaccines

Clinical Trials on Gardasil and Gardasil-9

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe