Completed PHASE4 INTERVENTIONAL 3-arm NCT05426148

Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female

A Study to Assess the Immunogenicity Consistency of Three Consecutive Batches of Commercial-scale of Recombinant Human Papillomavirus(HPV) Bivalent Vaccine (Escherichia Coli) in Healthy Female Subjects Aged 9-14 Years

Sponsor: Dongtai City Centers for Disease Control and Prevention

Conditions Cervical Cancer Cervical Intraepithelial Neoplasia Persistent Infection Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia

Interventions Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®

Updated 3 times since 2022 Last updated: Jun 22, 2022 Started: May 1, 2020 Primary completion: Aug 1, 2020 Completion: Apr 30, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Cervical Cancer and Cervical Intraepithelial Neoplasia and is currently completed. Dongtai City Centers for Disease Control and Prevention leads this study, which shows 3 recorded versions since 2020 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

3 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jul 2022 — Jul 2024 [monthly]

Completed PHASE4

First recorded

May 2020

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Dongtai City Centers for Disease Control and Prevention
Jiangsu Province Centers for Disease Control and Prevention
Xiamen Innovax Biotech Co., Ltd

Data source: Xiamen Innovax Biotech Co., Ltd

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Dongtai, China