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

CVIA-087

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

2021-03-15

2023-12-14

2023-12-14

Completed

Early phase I

1025

Inclusion Criteria: 1. 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 2. Ability and willingness to provide parental consent and, if applicable based on local in-country regulations, participant assent 3. Parent/LAR provides informed consent 4. Anticipated ability and willingness to complete all study visits and evaluations 5. Living within the catchment area of the study without plans to move during the conduct of the study Exclusion Criteria: 1. Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥38˚ C) 2. If participants have childbearing potential, must not be breastfeeding or confirmed pregnant 3. Receipt of an investigational product within 30 days prior to randomization 4. Receipt of blood and/or blood products (including immunoglobulin) 3 months prior to any dose of vaccination or blood sampling 5. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) 4 weeks prior and after each dose of HPV vaccine 6. History of any physical, mental, or developmental disorder that may hinder a participant's ability to comply with the study requirements 7. Any malignancy or confirmed or suspected immunodeficient condition such as HIV infection, based on medical history and physical examination 8. Receipt of or history of receipt of any medications or treatments that affect the immune system 9. Allergies to any components of the vaccine 10. Current or former participation in HPV vaccine related research. 11. Prior receipt of an investigational or licensed HPV vaccine 12. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1025, 'type': 'ACTUAL'}}

2024-01-10