Status:
COMPLETED
Phase 3 Trial of a Bivalent Human Papilloma Virus (HPV) Vaccine (Cecolin®) in Young Girls
Lead Sponsor:
PATH
Collaborating Sponsors:
International Centre for Diarrhoeal Disease Research, Bangladesh
Malaria Research Centre, Agogo Presbyterian Hospital, Ghana
Conditions:
Cervical Cancer
Eligibility:
FEMALE
9-14 years
Phase:
PHASE3
Brief 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,...
Detailed Description
This randomized, active-comparator controlled, open-label study will enroll total of approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country in South/Southeast As...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥ 38˚ C)
- If participants have childbearing potential, must not be breastfeeding or confirmed pregnant
- 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
- 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
- Current or former participation in HPV vaccine related research.
- Prior receipt of an investigational or licensed HPV 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
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2023
Estimated Enrollment :
1025 Patients enrolled
Trial Details
Trial ID
NCT04508309
Start Date
March 15 2021
End Date
December 14 2023
Last Update
January 30 2025
Active Locations (2)
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1
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
2
Malaria Research Centre, Agogo Presbyterian Hospital
Agogo, Ghana