HPV Vaccines Immunogenicity and SafetyPhase 3NCT02567955
Immunogenicity and Safety of Gardasil-9 and Cervarix
A Phase 3 study testing Immunogenicity two doses of Gardasil-9 and Immunogenicity Cervarix and Gardasil-9 in people with HPV Vaccines Immunogenicity and Safety, run by Laval University at 1 site in Canada.
Trial summary
A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. Read more about this study
- Who is it for?
- Ages 9 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccines Immunogenicity and Safety
- What is being tested?
- Immunogenicity two doses of Gardasil-9 and Immunogenicity Cervarix and Gardasil-9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Nov 2017
- 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 9 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9-10-year-old girls and boys
Who cannot join
- previously received an HPV vaccine
- immunosuppressed
- known allergy to a vaccine component
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule
A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.
Read the detailed description
The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.
- Conditions
- HPV Vaccines Immunogenicity and Safety
- Being tested
- Immunogenicity two doses of Gardasil-9, Immunogenicity Cervarix and Gardasil-9
- Keywords
- HPV vaccines, interchangeable use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunogenicity two doses of Gardasil-9Biological
Also called HPV vaccine
Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
Immunogenicity Cervarix and Gardasil-9Biological
Also called HPV vaccine
Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)
| Study group | Role | What they receive |
|---|---|---|
| Immunogenicity two doses of Gardasil-9 | Active comparator | Subjects will receive two doses of Gardasil-9 Receives: Biological: Immunogenicity two doses of Gardasil-9 |
| Immunogenicity Cervarix and Gardasil-9 | Experimental | Subjects will receive a dose Cervarix and a dose Gardasil-9 Receives: Biological: Immunogenicity Cervarix and Gardasil-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms
A Luminex Total IgG assay will be used to assess the presence of antibodies and antibody titers to 9 HPV genotypes included in the Gardasil-9 vaccine. Luminex Units will be used for the antibody titers assessment.
Measured: 36 months post-second dose of vaccine
Secondary outcomes (1)
Comparison of tolerability profile of Gardasil-9 and Cervarix
Local and general symptoms observed after each vaccine dose will be assessed by using a standardized diary card. Proportion of subjects who reported local and/or general symptoms will be compared.
Measured: During 5 days after each vaccine dose administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HPV Vaccines Immunogenicity and SafetyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567955
- Sponsor's protocol ID
- HPV 2355
- Status last verified
- Jan 2019
- First submitted
- 1 Oct 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ionescu IG, Ouakki M, Breton O, Panicker G, Unger ER, Gilca V, Sauvageau C. Follow up immunogenicity of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccines 36 months post-vaccination among boys and girls. Vaccine. 2026 Sep 3;92:129107. doi: 10.1016/j.vaccine.2026.129107. Online ahead of print.
PubMed 42691819Gilca 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 31017850Gilca V, Sauvageau C, Panicker G, De Serres G, Ouakki M, Unger ER. Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. Vaccine. 2018 Nov 12;36(46):7017-7024. doi: 10.1016/j.vaccine.2018.09.057. Epub 2018 Oct 9.
PubMed 30314913
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9-10-year-old Subjects According to 0-6 Month Schedule
- ClinicalTrials.gov ID
- NCT02567955
- Acronym / sponsor ID
- HPV 2355
- Conditions
- HPV Vaccines Immunogenicity and Safety
- Keywords
- HPV vaccines, interchangeable use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 5 Oct 2015 (estimated)
- 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.
A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine (Cervarix) are available. The main objective of this study is to assess the immunogenicity of ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys according to 0-6 month schedule.
Detailed description
The proportion of subjects with detectable antibodies and antibody geometrical mean titers to 9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first dose and 1, 18 and 36 months post-second dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunogenicity two doses of Gardasil-9 | Active comparator | Biological: Immunogenicity two doses of Gardasil-9Subjects will receive two doses of Gardasil-9 |
| Immunogenicity Cervarix and Gardasil-9 | Experimental | Biological: Immunogenicity Cervarix and Gardasil-9Subjects will receive a dose Cervarix and a dose Gardasil-9 |
Who may qualify
- Ages
- 9 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 9-10-year-old girls and boys
Key exclusion criteria (3 listed)
- previously received an HPV vaccine
- immunosuppressed
- known allergy to a vaccine component
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 |
|---|---|---|
| Immunogenicity two doses of Gardasil-9Also: HPV vaccineSubjects will receive two standard doses of Gardasil-9 (0.5 ml) | Biological | Immunogenicity two doses of Gardasil-9 |
| Immunogenicity Cervarix and Gardasil-9Also: HPV vaccineSubjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml) | Biological | Immunogenicity Cervarix and Gardasil-9 |
Primary outcome
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms
Time frame: 36 months post-second dose of vaccine
A Luminex Total IgG assay will be used to assess the presence of antibodies and antibody titers to 9 HPV genotypes included in the Gardasil-9 vaccine. Luminex Units will be used for the antibody titers assessment.
1 secondary outcome
Comparison of tolerability profile of Gardasil-9 and Cervarix
Time frame: During 5 days after each vaccine dose 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 18 Jan 2019.
- Derived from this study: PubMed 42691819Ionescu IG, Ouakki M, Breton O, Panicker G, Unger ER, Gilca V, Sauvageau C. Follow up immunogenicity of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccines 36 months post-vaccination among boys and girls. Vaccine. 2026 Sep 3;92:129107. doi: 10.1016/j.vaccine.2026.129107. Online ahead of print.
- 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.
- Derived from this study: PubMed 30314913Gilca V, Sauvageau C, Panicker G, De Serres G, Ouakki M, Unger ER. Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. Vaccine. 2018 Nov 12;36(46):7017-7024. doi: 10.1016/j.vaccine.2018.09.057. Epub 2018 Oct 9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immunogenicity two doses of Gardasil-9 and Immunogenicity Cervarix and Gardasil-9 in people with HPV Vaccines Immunogenicity and Safety, 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?
The sponsor lists 1 inclusion and 3 exclusion criteria. 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 18 Jan 2019. 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?
Comparison of proportion of subjects with detectable antibodies to 9 HPV genotypes included in the Gardasil-9 vaccine observed in two study arms (time frame: 36 months post-second dose of vaccine). 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 NCT02567955, which also lists 3 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 18 Jan 2019.