Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bivalent HPV vaccine CERVARIX® | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- NO_INTERVENTION
- label
- Cross-sectional baseline survey
- description
- 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
- type
- ACTIVE_COMPARATOR
- label
- Single Dose HPV vaccination
- description
- 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)
- interventionNames
- Biological: Bivalent HPV vaccine CERVARIX®
- type
- ACTIVE_COMPARATOR
- label
- Two-dose HPV vaccination
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion criteria A. Grade 8 (Mathayom 2): 1. Female students with identification card 2. Less than 15 years of age 3. Parent or guardian consent for vaccination and blood collection as applicable Participant assent for vaccination, questionnaire, and blood collection as applicable B. Baseline survey (Grade 10 / year 1, Grade 12 / year 3) 1\. Female students with identification card Participant assent for questionnaire and urine collection C. Year 2 post vaccination survey( Grade 10 / year 1) Year 4 post vaccination survey (Grade 12 / year 3) 1. Female students with identification card 2. Parent or guardian consent for blood collection as applicable 3. Participant assent for questionnaire, urine and blood collection from those vaccinated at Grade 8 as applicable Exclusion criteria A. Grade 8 (Mathayom 2): 1. Students who already received HPV vaccination 2. Reported pregnancy 3. 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 B. 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 C. 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
References
Publications (0)
Data not yet available