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

NCT03747770 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18000

Last updated 2020-04-22

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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)

Sponsors & Collaborators

  • Ministry of Health, Thailand

    collaborator OTHER_GOV

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Suchada Jiamsiri, MD · Department of Disease Control, Thailand Ministry of Public Health, Bangkok

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747770 on ClinicalTrials.gov