A Community Intervention Effectiveness Study: Single Dose or Two Doses of Bivalent HPV Vaccine (CERVARIX) in Female School Students in Thailand (IVIHPV1)

NCT03747770 NA UNKNOWN

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

Details

Lead sponsor	International Vaccine Institute
Phase	NA
Status	UNKNOWN
Enrolment	18000
Start date	2018-12-17
Completion	2023-06

Conditions

• Healthy

Interventions

• Bivalent HPV vaccine CERVARIX®

Primary outcomes

• HPV infection prevalence — Baseline survey (unvaccinated students) during the first year of the study
  HPV DNA PCR in urine
• HPV infection prevalence — Year 2, two years post vaccination
  HPV DNA PCR in urine
• HPV infection prevalence — Year 4, four years post vaccination
  HPV DNA PCR in urine
• Identification of HPV circulating strains — Baseline survey (unvaccinated students) during the first year of the study
  HPV genotyping on urine positive samples
• Identification of HPV circulating strains — Year 2, two years post vaccination
  HPV genotyping on urine positive samples
• Identification of HPV circulating strains — Year 4, four years post vaccination
  HPV genotyping on urine positive samples

Countries

Thailand