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Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students

NCT07156084 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-29

No results posted yet for this study

Summary

Since the 2019-2020 school year, the province of Quebec (Canada) has been administering one dose of nonavalent (9vHPV) vaccine to students of all genders in Grade 4 of elementary school through the school-based program.

Little data on the immunogenicity (antibody production) and long-term efficacy of a single dose of the vaccine are available, particularly in boys.

The primary objective of this study is to assess the persistence of HPV antibodies six years after the administration of a single dose of the 9vHPV vaccine to students aged 9 to 11 years in Grade 4 in 2019-2020.

The study will be conducted at the CHU de Québec-Université Laval research center.

Recruitment is conducted through school service centers in the Quebec City region. Youth who received only a single dose of the 9vHPV vaccine at the ages of 9-11 in 2019-2020 will be eligible to participate.

Approximately 300 youth will take part in this study: 150 girls and 150 boys.

Participants will have to answer few questions about their health to ensure their eligibility for the study. For eligible participants consenting to participate a 10 ml (\<1 tablespoon) blood sample will be taken.

Conditions

  • HPV Vaccine

Interventions

BIOLOGICAL

HPV nonavalent vaccine (Gardasil-9)

One dose HPV nonavalent vaccine

Sponsors & Collaborators

  • Canadian Immunization Research Network

    lead NETWORK

Principal Investigators

  • Chantal Sauvageau, MD · INSPQ and Laval University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • Canada

Study Locations

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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 NCT07156084 on ClinicalTrials.gov