Dose Schedule StudyNCT00524745
Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil
A study testing Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in people with Dose Schedule Study, run by PATH at 1 site in Vietnam.
Trial summary
To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is… Read more about this study
- Who is it for?
- Ages 11 to 13 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dose Schedule Study
- What is being tested?
- Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 13 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 11-13 years of age.
- Signed informed consent form (both parent's \& daughter's signature).
- Good health status.
- Able to comply with trial protocol.
- Plans to stay at current school for duration of study.
Who cannot join
- Prior HPV vaccination
- Pregnant or lactating or intends to become pregnant during study period.
- Apparent moderate or severe acute illness.
- Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
- Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
- Hypersensitivity to the active substances or to any of the excipients of the HPV vaccine, or such reactions to other vaccines received in the past.
- Investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of HPV vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.
Read the detailed description
OBJECTIVES:
Primary objective:
To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
Secondary objectives:
- To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
- To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing: (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.
- Conditions
- Dose Schedule Study
- Being tested
- Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- Keywords
- Gardasil, Human Papillomavirus, HPV vaccine, Cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineBiological
Three doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms.
| Study group | Role | What they receive |
|---|---|---|
| 0,2,6 month vaccination schedule | Active comparator | Not described Receives: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,3,9 month vaccination schedule | Active comparator | Not described Receives: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,6,12 month vaccination schedule | Active comparator | Not described Receives: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,12,24 month vaccination schedule | Active comparator | Not described Receives: Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Measured: 25 months
Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Measured: 25 months
Secondary outcomes (2)
Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Measured: 25 months
Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dose Schedule StudyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Responsible party
- Sponsor
- Investigators
- Kathy Neuzil, MD, MPH, Principal investigator, PATH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524745
- Sponsor's protocol ID
- HPV01
- Status last verified
- Jul 2012
- First submitted
- 31 Aug 2007
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Neuzil KM, Canh DG, Thiem VD, Janmohamed A, Huong VM, Tang Y, Diep NT, Tsu V, LaMontagne DS. Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial. JAMA. 2011 Apr 13;305(14):1424-31. doi: 10.1001/jama.2011.407.
PubMed 21486975Widdice LE, Unger ER, Panicker G, Hoagland R, Callahan ST, Jackson LA, Berry AA, Kotloff K, Frey SE, Harrison CJ, Pahud BA, Edwards KM, Mulligan MJ, Sudman J, Bernstein DI. Antibody responses among adolescent females receiving two or three quadrivalent human papillomavirus vaccine doses at standard and prolonged intervals. Vaccine. 2018 Feb 1;36(6):881-889. doi: 10.1016/j.vaccine.2017.12.042. Epub 2018 Jan 3.
PubMed 29306506Lamontagne DS, Thiem VD, Huong VM, Tang Y, Neuzil KM. Immunogenicity of quadrivalent HPV vaccine among girls 11 to 13 Years of age vaccinated using alternative dosing schedules: results 29 to 32 months after third dose. J Infect Dis. 2013 Oct 15;208(8):1325-34. doi: 10.1093/infdis/jit363. Epub 2013 Jul 30.
PubMed 23901077
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immunogenicity and Reactogenicity of Alternative Schedules of Gardasil Vaccine to Prevent HPV Infection
- ClinicalTrials.gov ID
- NCT00524745
- Acronym / sponsor ID
- HPV01
- Conditions
- Dose Schedule Study
- Keywords
- Gardasil, Human Papillomavirus, HPV vaccine, Cervical cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam
- Study start
- Oct 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 8 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that Gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-HPV type 16 and anti-HPV type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.
Detailed description
OBJECTIVES:
Primary objective:
To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 16 and anti-HPV 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
Secondary objectives:
- To test the hypothesis that Gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-HPV 6 and anti-HPV 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months.
- To describe the safety profile of the administration of Gardasil® according to each of the four schedules by assessing: (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0,2,6 month vaccination schedule | Active comparator | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,3,9 month vaccination schedule | Active comparator | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,6,12 month vaccination schedule | Active comparator | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
| 0,12,24 month vaccination schedule | Active comparator | Biological: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 11-13 years of age.
- Signed informed consent form (both parent's \& daughter's signature).
- Good health status.
- Able to comply with trial protocol.
- Plans to stay at current school for duration of study.
Key exclusion criteria (7 listed)
- Prior HPV vaccination
- Pregnant or lactating or intends to become pregnant during study period.
- Apparent moderate or severe acute illness.
- Clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy.
- Clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes.
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 |
|---|---|---|
| Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineThree doses of quadrivalent HPV recombinant vaccine administered at different dosing intervals in each of four study arms. | Biological | 0,12,24 month vaccination schedule, 0,2,6 month vaccination schedule, 0,3,9 month vaccination schedule, 0,6,12 month vaccination schedule |
Primary outcome
Comparison of Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Time frame: 25 months
Comparison of Antibody Response to HPV Type 18 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Time frame: 25 months
2 secondary outcomes
Comparison of Antibody Response to HPV Type 6 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Time frame: 25 months
Comparison of Antibody Response to HPV Type 11 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule.
Time frame: 25 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21486975Neuzil KM, Canh DG, Thiem VD, Janmohamed A, Huong VM, Tang Y, Diep NT, Tsu V, LaMontagne DS. Immunogenicity and reactogenicity of alternative schedules of HPV vaccine in Vietnam: a cluster randomized noninferiority trial. JAMA. 2011 Apr 13;305(14):1424-31. doi: 10.1001/jama.2011.407.
- Derived from this study: PubMed 29306506Widdice LE, Unger ER, Panicker G, Hoagland R, Callahan ST, Jackson LA, Berry AA, Kotloff K, Frey SE, Harrison CJ, Pahud BA, Edwards KM, Mulligan MJ, Sudman J, Bernstein DI. Antibody responses among adolescent females receiving two or three quadrivalent human papillomavirus vaccine doses at standard and prolonged intervals. Vaccine. 2018 Feb 1;36(6):881-889. doi: 10.1016/j.vaccine.2017.12.042. Epub 2018 Jan 3.
- Derived from this study: PubMed 23901077Lamontagne DS, Thiem VD, Huong VM, Tang Y, Neuzil KM. Immunogenicity of quadrivalent HPV vaccine among girls 11 to 13 Years of age vaccinated using alternative dosing schedules: results 29 to 32 months after third dose. J Infect Dis. 2013 Oct 15;208(8):1325-34. doi: 10.1093/infdis/jit363. Epub 2013 Jul 30.
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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.
Kathy Neuzil, MD, MPH principal investigator
PATH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in people with Dose Schedule Study, run by PATH at 1 site in Vietnam.
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 5 inclusion and 7 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 14 Apr 2017. 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 Vietnam. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Antibody Response to HPV Type 16 1 Month Post-dose 3 for Each Alternative Schedule Compared to the Standard Schedule. (time frame: 25 months). The study lists 2 primary outcomes in all. 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 NCT00524745, 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 14 Apr 2017.