NCT03431246

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

January 26, 2018

Last Update Submit

February 6, 2018

Conditions

Human Papillomavirus Vaccines

Outcome Measures

Primary Outcomes (1)

  • Anti-HPV seropositivity

    Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.

    One month post vaccine administration.

Secondary Outcomes (1)

  • HPV antibody titers

    One month post vaccine administration

Study Arms (1)

Gardasil and Gardasil-9

EXPERIMENTAL
Biological: Gardasil and Gardasil-9

Interventions

Gardasil and Gardasil-9BIOLOGICAL

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.

Gardasil and Gardasil-9

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on self-representation of gender identity
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University Research Hospital Center

Québec, G1E7G9, Canada

Location

Related Publications (2)

  • 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.

    PMID: 40664165DERIVED

  • 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.

    PMID: 31017850DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

Study Officials

  • Gaston DeSerres, MD, PhD

    Quebec Public Health Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single group exploratory study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Epidemiologist

Study Record Dates

First Submitted

January 26, 2018

First Posted

February 13, 2018

Study Start

October 1, 2016

Primary Completion

November 5, 2016

Study Completion

December 5, 2016

Last Updated

February 13, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)