NCT03747770

Effectiveness of Single Dose or Two Doses of Bivalent HPV Vaccine in Thailand

A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18,000 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: Female
• Age: 13 Years – 15 Years
• Healthy volunteers: Accepted

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 grade female students 2. 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: 1\) 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

Interventions

Type	Name	Description
BIOLOGICAL	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)

Timeline

• Start date: 2018-12-17
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2018-11-20
• Last updated: 2020-04-22

Locations

1 site across 1 country: Thailand