Recruiting

9vHPV

Sponsor:

Canadian Immunization Research Network

Code:

NCT07156084

Conditions

HPV Vaccine

Eligibility Criteria

Sex: All

Age: 15 - 17

Healthy Volunteers: Accepted

Interventions

HPV nonavalent vaccine (Gardasil-9)

Study Details

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.

Conditions

HPV Vaccine

Study ID

NCT07156084

Start date

Sep 23, 2025

Status verified date

Sep, 2025

Completion date

Feb, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 17

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: One HPV vaccine dose received 6 years before recruitment

Interventions

HPV nonavalent vaccine (Gardasil-9)

One dose HPV nonavalent vaccine

Primary outcome measure

  • Detectable antibodies [ Time Frame: At recruitment (6 years post-one HPV vaccine dose) ]
  • Geometric mean concentrations [ Time Frame: At recruitment (6 years post-one HPV vaccine dose) ]

Central Contacts and Locations

Central contacts

Chantal Sauvageau, MD

418650-5115chantal.sauvageau@inspq.qc.ca

Jo-Ann Costa

jo-anne.costa.ciussscn@ssss.gouv.qc.ca

Locations

Centre de recherche du CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada, G1X4S9

Contacts

Chantal Sauvageau, MD

1+ 418 666-7000chantal.sauvageau@inspq.qc.ca

More Information

Sponsor

Canadian Immunization Research Network

Last update posted

Sep 29, 2025

Last verified

Sep, 2025

Keywords

  • HPV
  • Vaccination
  • Schedule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Immunization Research Network on 2025-09-29.