Human Papillomavirus VaccinesPhase 3NCT03431246
Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9
A Phase 3 study testing Gardasil and Gardasil-9 in people with Human Papillomavirus Vaccines, run by Laval University at 1 site in Canada.
Trial summary
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9 Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccines
- What is being tested?
- Gardasil and Gardasil-9
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2016to 5 Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.
-
Exclusion Criteria: Immunossupressed or blood coagulation problems
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
Read the detailed description
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
- Human Papillomavirus Vaccines
- Being tested
- Gardasil and Gardasil-9
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Gardasil and Gardasil-9 | Experimental | Not described Receives: Biological: Gardasil and Gardasil-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HPV seropositivity
Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
Measured: One month post vaccine administration.
Secondary outcomes (1)
HPV antibody titers
Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed
Measured: One month post vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Oct 2016
- Primary completion5 Nov 2016
- Study completion5 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus VaccinesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group exploratory study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Vladimir Gilca, Laval University
- Investigators
- Gaston DeSerres, MD, PhD, Study chair, Quebec Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431246
- Sponsor's protocol ID
- CÉ: 2017-3036-21
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40664165Gilca 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.
PubMed 31017850
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later
- ClinicalTrials.gov ID
- NCT03431246
- Acronym / sponsor ID
- CÉ: 2017-3036-21
- Conditions
- Human Papillomavirus Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group exploratory study
| Arm | Type | Receives |
|---|---|---|
| Gardasil and Gardasil-9 | Experimental | Biological: Gardasil and Gardasil-9 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gardasil and Gardasil-9All 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. | Biological | Gardasil and Gardasil-9 |
Primary outcome
Anti-HPV seropositivity
Time frame: One month post vaccine administration.
Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed.
1 secondary outcome
HPV antibody titers
Time frame: One month post vaccine administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 40664165Guzun 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.
- Derived from this study: PubMed 31017850Gilca 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaston DeSerres, MD, PhD study chair
Quebec Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gardasil and Gardasil-9 in people with Human Papillomavirus Vaccines, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HPV seropositivity (time frame: One month post vaccine administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03431246, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.