Papilloma Viral InfectionPhase 4PROM SSCOLNCT04459221
Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students
A Phase 4 study testing Gardasil 9, 9-Valent Intramuscular Suspension in people with Papilloma Viral Infection, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000… Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Papilloma Viral Infection
- What is being tested?
- Gardasil 9, 9-Valent Intramuscular Suspension
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 30 Dec 2021
- Phase
- Phase 4
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- schooled in one of the classes drawn at random in the 2 colleges selected for the study,
- members or beneficiaries of a social security scheme,
- having agreed to participate in the study and whose parents or holder (s) of parental authority have signed a free, informed and written consent.
Who cannot join
- under the age of 9, or over the age of 17 at inclusion,
- with hypersensitivity to the active substances or to any of the excipients of the vaccine (Gardasil 9®),
- with a permanent contraindication to vaccination.
- having already initiated the HPV vaccination (complete or incomplete scheme). Students with an incomplete vaccination schedule will be referred to their attending physician to complete the missing dose (s).
- pregnancy or breastfeeding (based on the declaration)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de la Réunion
Saint-Pierre, 97448
About this study
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.
CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.
Read more
CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.
In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.
Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.
- Conditions
- Papilloma Viral Infection
- Being tested
- Gardasil 9, 9-Valent Intramuscular Suspension
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil 9, 9-Valent Intramuscular SuspensionDrug
access to HPV vaccination near the college in a health bus
| Study group | Role | What they receive |
|---|---|---|
| Facilitating access to HPV vaccination | Experimental | Not described Receives: Drug: Gardasil 9, 9-Valent Intramuscular Suspension |
| promotion of HPV vaccination | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the vaccination rate in girls
Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated
Measured: 9 month
Secondary outcomes (2)
increase the vaccination rate in all student
number of student having completed a complete vaccination schedule
Measured: 9 month
increase the vaccination rate in all student
number of student having completed a incomplete vaccination schedule
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Nov 2020
- Primary completion25 Jun 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papilloma Viral InfectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459221
- Sponsor's protocol ID
- 2020/CHU/05
- Other IDs
- 2020-002332-73
- Acronym
- PROM SSCOL
- Status last verified
- Mar 2022
- First submitted
- 1 Jul 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran PL, Chirpaz E, Boukerrou M, Bertolotti A. Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e35695. doi: 10.2196/35695.
PubMed 35700023
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of a School Program Combining - Promotion of HPV Vaccination and HPV Vaccine Offer in Middle School - on Adherence to HPV Vaccination in Middle School Students
- ClinicalTrials.gov ID
- NCT04459221
- Acronym / sponsor ID
- PROM SSCOL / 2020/CHU/05
- Conditions
- Papilloma Viral Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Jul 2020 (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.
Cervical cancer (CCU) is the fourth most common cancer in women worldwide. In Reunion island, CCU is the third leading cause of cancer in women (standardized incidence rate on the world population (TIS) in 2013 of 10.3 / 100,000) and is the eighth deadliest cancer with a rate standardized mortality of 4.8 / 100,000, almost three times higher than in mainland France where it was 1.7 / 100,000 in 2018.
CCU results from infection with the human papillomavirus (HPV), which is the most common sexually transmitted viral infection.
CCU prevention is mainly based on cervical smear screening and anti HPV vaccination (VHPV) which has demonstrated its effectiveness on the prevalence of HPV carriage, but also on incidence of condyloma or intermediate grade dysplasia. Since HPV is mainly transmitted sexually, it is important to vaccinate before the start of sex.
In Reunion island, the HPV vaccination coverage rate is the lowest in France, estimated by Public Health France at 8.1% among girls aged 16 years in 2018, while the already low national average was established 23.7%.
Thus, in view of the epidemiological situation in Reunion island (high incidence and mortality for the CCU, very low VHPV coverage rate), we thought it would be interesting to study the impact of a health promotion program sex and prevention of sexually transmitted infections (STIs) including papillomavirus-related pathologies, with a program to promote HPV vaccination among young students in middle school.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facilitating access to HPV vaccination | Experimental | Drug: Gardasil 9, 9-Valent Intramuscular Suspension |
| promotion of HPV vaccination | No intervention | – |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- schooled in one of the classes drawn at random in the 2 colleges selected for the study,
- members or beneficiaries of a social security scheme,
- having agreed to participate in the study and whose parents or holder (s) of parental authority have signed a free, informed and written consent.
Key exclusion criteria (5 listed)
- under the age of 9, or over the age of 17 at inclusion,
- with hypersensitivity to the active substances or to any of the excipients of the vaccine (Gardasil 9®),
- with a permanent contraindication to vaccination.
- having already initiated the HPV vaccination (complete or incomplete scheme). Students with an incomplete vaccination schedule will be referred to their attending physician to complete the missing dose (s).
- pregnancy or breastfeeding (based on the declaration)
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 9, 9-Valent Intramuscular Suspensionaccess to HPV vaccination near the college in a health bus | Drug | Facilitating access to HPV vaccination |
Primary outcome
Change the vaccination rate in girls
Time frame: 9 month
Number of girls having completed a complete vaccination schedule. Hypothesis: the intervention under study should increase the rate of vaccinated
2 secondary outcomes
increase the vaccination rate in all student
Time frame: 9 month
increase the vaccination rate in all student
Time frame: 9 month
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 2 Mar 2022.
- Derived from this study: PubMed 35700023Tran PL, Chirpaz E, Boukerrou M, Bertolotti A. Impact of a Papillomavirus Vaccination Promotion Program in Middle School: Study Protocol for a Cluster Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e35695. doi: 10.2196/35695.
- 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.
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 4 study testing Gardasil 9, 9-Valent Intramuscular Suspension in people with Papilloma Viral Infection, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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 3 inclusion and 5 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 2 Mar 2022. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change the vaccination rate in girls (time frame: 9 month). 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 NCT04459221, which also lists 1 linked publication.
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 2 Mar 2022.