NCT04508309CompletedPhase 3
Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls
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
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1025 (actual)
- First submitted
- 4 Aug 2020
- Start date
- 15 Mar 2021
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- PATH
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT04508309
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1025
- From 15 Mar 2021 to the primary completion date, 14 Dec 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receipt of an investigational product within 30 days prior to randomization
- Receipt of blood and/or blood products (including immunoglobulin) 3 months prior to any dose of vaccination or blood sampling
- Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as Measles, Mumps, and Rubella (MMR), or yellow fever vaccine but not including live attenuated influenza virus vaccine) 4 weeks prior and after each dose of HPV vaccine
- Current or former participation in HPV vaccine related research.
- Prior receipt of an investigational or licensed HPV vaccine
Other illness
- Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥ 38˚ C)
- History of any physical, mental, or developmental disorder that may hinder a participant's ability to comply with the study requirements
- Any malignancy or confirmed or suspected immunodeficient condition such as HIV infection, based on medical history and physical examination
- Receipt of or history of receipt of any medications or treatments that affect the immune system
- Allergies to any components of the vaccine
- Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
Other
- If participants have childbearing potential, must not be breastfeeding or confirmed pregnant
Who the study is looking for
- Healthy (determined by investigator's assessment following medical history and physical examination, laboratory evaluation could be performed at the investigator's discretion) female between the ages of 9 - 14 years (all inclusive) at time of enrollment
- Ability and willingness to provide parental consent and, if applicable based on local in-country regulations, participant assent
- Parent/Legally Acceptable Representative provides informed consent
- Anticipated ability and willingness to complete all study visits and evaluations
- Living within the catchment area of the study without plans to move during the conduct of the study
Age in the registry: 9 years to 14 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| International Centre for Diarrhoeal Disease Research Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
| Malaria Research Centre, Agogo Presbyterian Hospital Coordinator of this site? Confirm its status | Agogo | Ghana | Unknown status |
Related publications
- Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis.Cochrane Database Syst Rev · 2025 · PMID 41276263
This page is information, not medical advice. Discuss any trial with your doctor.