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

NCT ID: NCT03431246

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2016-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus Vaccines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group exploratory study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gardasil and Gardasil-9

Group Type EXPERIMENTAL

Gardasil and Gardasil-9

Intervention Type BIOLOGICAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vladimir Gilca

Medical Epidemiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gaston DeSerres, MD, PhD

Role: STUDY_CHAIR

Quebec Public Health Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laval University Research Hospital Center

Québec, , Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Guzun N, Ouakki M, Panicker G, Ionescu IG, Mayrand MH, Unger ER, Sauvageau C. Immune response after one dose of HPV vaccine among girls and boys and the impact of a second dose given after 3 or more years. Vaccine. 2025 Aug 30;62:127475. doi: 10.1016/j.vaccine.2025.127475. Epub 2025 Jul 14.

Reference Type DERIVED
PMID: 40664165 (View on PubMed)

Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3.

Reference Type DERIVED
PMID: 31017850 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CÉ: 2017-3036-21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose
NCT03943875 ACTIVE_NOT_RECRUITING PHASE4
Assessing Durable Antibody Response to HPV Vaccination
NCT05031078 ACTIVE_NOT_RECRUITING PHASE4