CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,025 enrolled
Drug / intervention
Cecolin® +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04508309
NCT04508309Phase 3Completed
CompareCT.gov

Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries

PATH·interventional·Posted Aug 11, 2020·Updated Jan 30, 2025

In Brief

A Phase 3 clinical trial evaluating Cecolin® and Gardasil® for Cervical Cancer. Completed, enrolled 1,025 participants across 2 sites in 2 countries.

Detailed Summary

This randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® will be used as the comparator vaccine, as this vaccine is most widely used in low- and low-middle income countries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesBangladesh, Ghana
CollaboratorsInternational Centre for Diarrhoeal Disease Research, Bangladesh, Malaria Research Centre, Agogo Presbyterian Hospital, Ghana, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA, The Emmes Company, LLC, Xiamen Innovax Biotech Co., Ltd

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 11, 2020
Enrollment StartMar 15, 2021
Primary CompletionDec 14, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.9 years ago

Interventions

Cecolin®biological

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine

Gardasil®biological

Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine