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Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls

NCT04508309 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1025

Last updated 2025-01-30

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Cecolin®

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine

BIOLOGICAL

Gardasil®

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

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Malaria Research Centre, Agogo Presbyterian Hospital, Ghana

    collaborator UNKNOWN

  • Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., USA

    collaborator UNKNOWN

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • PATH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2023-12-14
Completion
2023-12-14

Countries

  • Bangladesh
  • Ghana

Study Locations

More Related Trials

Entities

Diseases

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 NCT04508309 on ClinicalTrials.gov