Trial intelligence / Profile preview

15-valent HPV vaccine in healthy Chinese people aged 9-45 years

NCT06756269Phase 2

Key facts

Status
Recruiting
Start
Jan 2025
Primary completion
Oct 2025
Countries
1
Modality
Vaccines & Immunotherapeutics
Conditions
human papillomavirus infectionHPV-related carcinomaHuman papillomavirus–related intraepithelial neoplasia (HPV-IN)genital warts
01

Overview

Phase 2, randomised, double-blind trial of 15-valent human papillomavirus recombinant vaccine in human papillomavirus infection, HPV-related carcinoma, Human papillomavirus–related intraepithelial neoplasia (HPV-IN) and 1 more (4 arms), sponsored by Shanghai Bovax Biotechnology Co., Ltd. Primary endpoints: Adverse Events at 30 minutes, Solicited Adverse Events at 14 days and 3 more. Started Jan 2025; status: recruiting.

02

Design

4 arms
Study design
RandomizedDouble-blind
  • Medium dose 15-HPV vaccine

    Medium dose 15-valent HPV vaccine at 0, 2, 6 months

  • High dose 15-HPV vaccine

    High dose 15-valent HPV vaccine at 0, 2, 6 months

  • Placebo

    Placebo at 0, 2, 6 months

  • 9-HPV vaccine

    9-valent HPV vaccine at 0, 2, 6 months (active comparator, 18-45 years only)

03

Who it enrols

Healthy Chinese participants aged 9-45 years with no prior HPV vaccination, no history of HPV infection or related diseases, no immunodeficiency or autoimmune conditions, and no recent vaccination or immunosuppressive therapy

04

Endpoints

Primary

  • Adverse Events

  • Solicited Adverse Events

  • Unsolicited Adverse Events

  • Serious Adverse Events

  • Pregnancy Events

Secondary

  • Immunogenicity after receiving 3 doses of 15-HPV vaccine

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