Human PapillomavirusPhase 3NCT01456715
Immunogenicity of Gardasil and Twinrix and the Effect of a Dose of Gardasil or Cervarix Given 42 Months Later.
A Phase 3 study testing Gardasil vaccine, Immunogenicity, Booster dose. and Cervarix Vaccine, Immunogenicity, Booster Dose. in people with Human Papillomavirus, run by Laval University at 1 site in Canada.
Trial summary
Two human papillomavirus vaccines are now commercially available. No clinical data exist regarding: The immunogenicity and safety of Gardasil and Twinrix when co-administered. The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil. Read more about this study
- Who is it for?
- Ages 12 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Gardasil vaccine, Immunogenicity, Booster dose. and Cervarix Vaccine, Immunogenicity, Booster Dose.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Dec 2018
- 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 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.
Who cannot join
- Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.
Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
Read more
- The immunogenicity and safety of Gardasil and Twinrix when co-administered.
- The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.
The main objective of the first phase of this clinical trial was:
- To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
- To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design \& Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
One Center.
- Conditions
- Human Papillomavirus
- Being tested
- Gardasil vaccine, Immunogenicity, Booster dose., Cervarix Vaccine, Immunogenicity, Booster Dose.
- Keywords
- Human Papillomavirus Vaccines, Immunogenicity Gardasil Cervarix, Booster dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardasil vaccine, Immunogenicity, Booster dose.Biological
Also called HPV vaccine
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
Cervarix Vaccine, Immunogenicity, Booster Dose.Biological
Also called HPV vaccine.
Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
| Study group | Role | What they receive |
|---|---|---|
| Gardasil, Immunogenicity, Booster dose. | Active comparator | Not described Receives: Biological: Gardasil vaccine, Immunogenicity, Booster dose. |
| Cervarix, Immunogenicity, Booster dose. | Experimental | Not described Receives: Biological: Cervarix Vaccine, Immunogenicity, Booster Dose. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody to HPV
The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil.
Measured: 1 month post booster dose
Secondary outcomes (1)
Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.
Measured: Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Gilca, Laval University
- Investigators
- Vladimir Gilca, MD, PhD, Principal investigator, INSPQ, CHUQ-CHUL, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456715
- Sponsor's protocol ID
- 122.05.01
- Other IDs
- 9427-L1802/1-21C
- Status last verified
- Mar 2020
- First submitted
- 18 Oct 2011
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.
- ClinicalTrials.gov ID
- NCT01456715
- Acronym / sponsor ID
- 122.05.01
- Conditions
- Human Papillomavirus
- Keywords
- Human Papillomavirus Vaccines, Immunogenicity Gardasil Cervarix, Booster dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Sep 2008 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Oct 2011 (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.
Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
- The immunogenicity and safety of Gardasil and Twinrix when co-administered.
- The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.
The main objective of the first phase of this clinical trial was:
- To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
- To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design \& Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
One Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gardasil, Immunogenicity, Booster dose. | Active comparator | Biological: Gardasil vaccine, Immunogenicity, Booster dose. |
| Cervarix, Immunogenicity, Booster dose. | Experimental | Biological: Cervarix Vaccine, Immunogenicity, Booster Dose. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.
Key exclusion criteria (1 listed)
- Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.
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 vaccine, Immunogenicity, Booster dose.Also: HPV vaccineGardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later. | Biological | Gardasil, Immunogenicity, Booster dose. |
| Cervarix Vaccine, Immunogenicity, Booster Dose.Also: HPV vaccine.Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later. | Biological | Cervarix, Immunogenicity, Booster dose. |
Primary outcome
Antibody to HPV
Time frame: 1 month post booster dose
The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil.
1 secondary outcome
Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.
Time frame: Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.
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 5 Mar 2020.
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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.
Vladimir Gilca, MD, PhD principal investigator
INSPQ, CHUQ-CHUL, Laval University
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 vaccine, Immunogenicity, Booster dose. and Cervarix Vaccine, Immunogenicity, Booster Dose. in people with Human Papillomavirus, 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 1 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 5 Mar 2020. 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?
Antibody to HPV (time frame: 1 month post booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2020.