NCT07156084 Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students
| NCT ID | NCT07156084 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Canadian Immunization Research Network |
| Condition | HPV Vaccine |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 300 participants in total. It began in 2025-09-23 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Have received a single dose of 9vHPV vaccine at ages 9-11 during the school year 2019-2020; * Not have received any other HPV vaccine doses; * Be able to consent to the study. Exclusion Criteria: * Immunosuppressed (at recruitment or when immunized).
Contact & Investigator
Chantal Sauvageau, MD
PRINCIPAL INVESTIGATOR
INSPQ and Laval University
Frequently Asked Questions
Who can join the NCT07156084 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 17 Years, studying HPV Vaccine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07156084 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07156084 currently recruiting?
Yes, NCT07156084 is actively recruiting participants. Contact the research team at chantal.sauvageau@inspq.qc.ca for enrollment information.
Where is the NCT07156084 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT07156084 clinical trial?
NCT07156084 is sponsored by Canadian Immunization Research Network. The principal investigator is Chantal Sauvageau, MD at INSPQ and Laval University. The trial plans to enroll 300 participants.