HealthyIVIHPV1NCT03747770
Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand
A study testing Bivalent HPV vaccine CERVARIX® in people with Healthy, run by International Vaccine Institute at 1 site in Thailand.
Trial summary
This is a community intervention effectiveness study in female school students in Thailand. The study objectives are: 1. To demonstrate HPV vaccine effectiveness of Single Dose (SD) by a reduction in vaccine-type HPV prevalence (HPV 16 and HPV 18) at Year 2 and Year 4 post vaccination compared to unvaccinated same… Read more about this study
- Who is it for?
- Ages 13 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bivalent HPV vaccine CERVARIX®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,000 participants
- Where
- 1 siteThailand
- Study dates
- 17 Dec 2018to Jun 2023
- Phase
- Interventional
- 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 13 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Grade 8 (Mathayom 2):
- Female students with identification card
- Less than 15 years of age
- Parent or guardian consent for vaccination and blood collection as applicable Participant assent for vaccination, questionnaire, and blood collection as applicable
- Baseline survey (Grade 10 / year 1, Grade 12 / year 3)
- 1. Female students with identification card Participant assent for questionnaire and urine collection
Show all 10Show fewer
- Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)
- Female students with identification card
- Parent or guardian consent for blood collection as applicable
- Participant assent for questionnaire, urine and blood collection from those vaccinated at Grade 8 as applicable
Who cannot join
- Grade 8 (Mathayom 2):
- Students who already received HPV vaccination
- Reported pregnancy
- Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
- Baseline survey (Grade 10 / year 1, Grade 12 / year 3) 1. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
- Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3)
- 1. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ministry of Public Health
Bangkok, Chang Wat Nonthaburi, 11000
About this study
Official title: A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand
This is a community intervention effectiveness study in female school students in Thailand.
The study objectives are:
- To demonstrate HPV vaccine effectiveness of Single Dose (SD) by a reduction in vaccine-type HPV prevalence (HPV 16 and HPV 18) at Year 2 and Year 4 post vaccination compared to unvaccinated same grade female students
- To demonstrate that HPV vaccine effectiveness of SD and two-dose (2D) regimens are similar by comparing reductions in vaccine type prevalence at Year 2 and Year 4 post vaccination compared with the baseline surveys in the two provinces
Read the detailed description
The study will investigate the effectiveness of a SD of HPV vaccine through the conduct of a regional effectiveness study in Thailand.
The study will be conducted in schools and district hospitals from the two selected provinces (Udon Thani and Buriram)
The study design includes 4 distinct and independent components:
- vaccination, 2)baseline cross-sectional survey, 3,4)sequential cross-sectional surveys for impact assessments at Year 2 and Year 4 post vaccination.
- Vaccination: The target population is represented by all Grade 8 female students in the two provinces. All enrolled students will receive either SD (Udon Thani) or 2D (Buriram). A subset (N=200/province) of Grade 8 female students in each province will be selected for a blood collection before vaccination for assessment of vaccine immunogenicity.
- Surveys (baseline, Year 2 and Year 4 impact surveys): Target populations of are a subset of female students of Grades 10 High school (HS)/year 1 Vocational School (VS) and Grade 12 HS/year 3 VS from all schools in the two provinces and the sampling unit is an individual. Urine collection will be performed to assess HPV infection by DNA PCR and for genotyping of positive samples. A subset of students (N=200 per province) will be randomly selected for each of the Year 2 and Year 4 surveys for blood collection for assessment of vaccine immunogenicity.
- Demographics and sexual behavior questionnaire will be collected from all students.
- Conditions
- Healthy
- Being tested
- Bivalent HPV vaccine CERVARIX®
- Keywords
- CERVARIX, Urine, DNA PCR, HPV infection, HPV genotyping, Effectiveness
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent HPV vaccine CERVARIX®Biological
Bivalent HPV vaccine(Glaxo Smith Kline, GSK, Rixensart, Belgium) presented as a suspension for intramuscular injection containing purified viral L1 protein for HPV types 16 and 18. Each 0.5 mL dose of the bivalent vaccine contains 20μg of HPV-16 L1 protein and 20 μg of HPV-18 L1 protein adsorbed onto a proprietary adjuvant system containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A (AS04)
| Study group | Role | What they receive |
|---|---|---|
| Cross-sectional baseline survey | No intervention | This are will collect behavioral questionnaire and urine in Grade 10 high school and Year 1 vocational school and Grade 12 high school and Year 3 Vocational school female students |
| Single Dose HPV vaccination | Active comparator | Grade 8 female students from Udon Thani Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Single Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium) Receives: Biological: Bivalent HPV vaccine CERVARIX® |
| Two-dose HPV vaccination | Active comparator | Grade 8 female students from Buriram Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Two-Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium) Receives: Biological: Bivalent HPV vaccine CERVARIX® |
| Cross-sectional survey at Year 2 | No intervention | This arm will collect behavioral questionnaire, urine and blood in Grade 10 high school and Year 1 vocational school female students |
| Cross-sectional survey at Year 4 | No intervention | Cross-sectional survey at Year 4 post vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV infection prevalence
HPV DNA PCR in urine
Measured: Baseline survey (unvaccinated students) during the first year of the study
HPV infection prevalence
HPV DNA PCR in urine
Measured: Year 2, two years post vaccination
HPV infection prevalence
HPV DNA PCR in urine
Measured: Year 4, four years post vaccination
Identification of HPV circulating strains
HPV genotyping on urine positive samples
Measured: Baseline survey (unvaccinated students) during the first year of the study
Identification of HPV circulating strains
HPV genotyping on urine positive samples
Measured: Year 2, two years post vaccination
Identification of HPV circulating strains
HPV genotyping on urine positive samples
Measured: Year 4, four years post vaccination
Secondary outcomes (1)
HPV type-specific antibody response prior and post vaccination
Blood Sample
Measured: Prior vaccination and at Year 2 and Year 4 Post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start17 Dec 2018
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Age range of subjects: 13 up to 18 years of age * Vaccination - grade 8: 13 to less than 15 years of age * Behavioral questionnaire: grade 8 (as above) and 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination * Urine collection: 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination * Blood collection: grade 8 (as above) and 15-18 years of age for Year 2 and Year 4 cross-sectional surveys post vaccination
- Masking
- None (open label)
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Responsible party
- Sponsor
- Investigators
- Suchada Jiamsiri, MD, Principal investigator, Department of Disease Control, Thailand Ministry of Public Health, Bangkok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747770
- Sponsor's protocol ID
- IVI HPV1
- Acronym
- IVIHPV1
- Status last verified
- Apr 2020
- First submitted
- 11 Nov 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand
- ClinicalTrials.gov ID
- NCT03747770
- Acronym / sponsor ID
- IVIHPV1 / IVI HPV1
- Conditions
- Healthy
- Keywords
- CERVARIX, Urine, DNA PCR, HPV infection, HPV genotyping, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Collaborators
- Ministry of Health, Thailand
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Nov 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 is a community intervention effectiveness study in female school students in Thailand.
The study objectives are:
- To demonstrate HPV vaccine effectiveness of Single Dose (SD) by a reduction in vaccine-type HPV prevalence (HPV 16 and HPV 18) at Year 2 and Year 4 post vaccination compared to unvaccinated same grade female students
- To demonstrate that HPV vaccine effectiveness of SD and two-dose (2D) regimens are similar by comparing reductions in vaccine type prevalence at Year 2 and Year 4 post vaccination compared with the baseline surveys in the two provinces
Detailed description
The study will investigate the effectiveness of a SD of HPV vaccine through the conduct of a regional effectiveness study in Thailand.
The study will be conducted in schools and district hospitals from the two selected provinces (Udon Thani and Buriram)
The study design includes 4 distinct and independent components:
- vaccination, 2)baseline cross-sectional survey, 3,4)sequential cross-sectional surveys for impact assessments at Year 2 and Year 4 post vaccination.
- Vaccination: The target population is represented by all Grade 8 female students in the two provinces. All enrolled students will receive either SD (Udon Thani) or 2D (Buriram). A subset (N=200/province) of Grade 8 female students in each province will be selected for a blood collection before vaccination for assessment of vaccine immunogenicity.
- Surveys (baseline, Year 2 and Year 4 impact surveys): Target populations of are a subset of female students of Grades 10 High school (HS)/year 1 Vocational School (VS) and Grade 12 HS/year 3 VS from all schools in the two provinces and the sampling unit is an individual. Urine collection will be performed to assess HPV infection by DNA PCR and for genotyping of positive samples. A subset of students (N=200 per province) will be randomly selected for each of the Year 2 and Year 4 surveys for blood collection for assessment of vaccine immunogenicity.
- Demographics and sexual behavior questionnaire will be collected from all students.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Age range of subjects: 13 up to 18 years of age * Vaccination - grade 8: 13 to less than 15 years of age * Behavioral questionnaire: grade 8 (as above) and 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination * Urine collection: 15-18 years of age for baseline (unvaccinated) and Year 2 and Year 4 cross-sectional surveys post vaccination * Blood collection: grade 8 (as above) and 15-18 years of age for Year 2 and Year 4 cross-sectional surveys post vaccination
| Arm | Type | Receives |
|---|---|---|
| Cross-sectional baseline survey | No intervention | –This are will collect behavioral questionnaire and urine in Grade 10 high school and Year 1 vocational school and Grade 12 high school and Year 3 Vocational school female students |
| Single Dose HPV vaccination | Active comparator | Biological: Bivalent HPV vaccine CERVARIX®Grade 8 female students from Udon Thani Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Single Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium) |
| Two-dose HPV vaccination | Active comparator | Biological: Bivalent HPV vaccine CERVARIX®Grade 8 female students from Buriram Province This arm will collect behavioral questionnaire and blood prior vaccination Intervention: Two-Dose HPV Vaccination with CERVARIX®(Glaxo Smith Kline, GSK, Rixensart, Belgium) |
| Cross-sectional survey at Year 2 | No intervention | –This arm will collect behavioral questionnaire, urine and blood in Grade 10 high school and Year 1 vocational school female students |
| Cross-sectional survey at Year 4 | No intervention | –Cross-sectional survey at Year 4 post vaccination |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Grade 8 (Mathayom 2):
- Female students with identification card
- Less than 15 years of age
- Parent or guardian consent for vaccination and blood collection as applicable Participant assent for vaccination, questionnaire, and blood collection as applicable
- Baseline survey (Grade 10 / year 1, Grade 12 / year 3)
Key exclusion criteria (7 listed)
- Grade 8 (Mathayom 2):
- Students who already received HPV vaccination
- Reported pregnancy
- Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
- Baseline survey (Grade 10 / year 1, Grade 12 / year 3) 1. Any student who has a preexisting known medical condition or diagnosed psychological illness which in the opinion of the Principal Investigator or designee may be detrimental to her wellbeing
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 |
|---|---|---|
| Bivalent HPV vaccine CERVARIX®Bivalent HPV vaccine(Glaxo Smith Kline, GSK, Rixensart, Belgium) presented as a suspension for intramuscular injection containing purified viral L1 protein for HPV types 16 and 18. Each 0.5 mL dose of the bivalent vaccine contains 20μg of HPV-16 L1 protein and 20 μg of HPV-18 L1 protein adsorbed onto a proprietary adjuvant system containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A (AS04) | Biological | Single Dose HPV vaccination, Two-dose HPV vaccination |
Primary outcome
HPV infection prevalence
Time frame: Baseline survey (unvaccinated students) during the first year of the study
HPV DNA PCR in urine
HPV infection prevalence
Time frame: Year 2, two years post vaccination
HPV DNA PCR in urine
HPV infection prevalence
Time frame: Year 4, four years post vaccination
HPV DNA PCR in urine
Identification of HPV circulating strains
Time frame: Baseline survey (unvaccinated students) during the first year of the study
HPV genotyping on urine positive samples
Identification of HPV circulating strains
Time frame: Year 2, two years post vaccination
HPV genotyping on urine positive samples
Identification of HPV circulating strains
Time frame: Year 4, four years post vaccination
HPV genotyping on urine positive samples
1 secondary outcome
HPV type-specific antibody response prior and post vaccination
Time frame: Prior vaccination and at Year 2 and Year 4 Post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- 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.
Suchada Jiamsiri, MD principal investigator
Department of Disease Control, Thailand Ministry of Public Health, Bangkok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bivalent HPV vaccine CERVARIX® in people with Healthy, run by International Vaccine Institute at 1 site in Thailand.
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 10 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: status not confirmed, as of the sponsor's last update on 22 Apr 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 Thailand. 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?
Results are not available in the source record.
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?
HPV infection prevalence (time frame: Baseline survey (unvaccinated students) during the first year of the study). The study lists 6 primary outcomes in all. 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 22 Apr 2020.