Cancer
Conditions
Interventions
Sponsors
PATH
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy 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
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. History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection 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 protocolmply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-HPV 16 and 18 IgG antibody geometric mean concentration (GMC), measured by enzyme-linked immunosorbent assay (ELISA) one month after the second dose on Month 7 (for the 0, 6-month arms), Month 13 (for the 0, 12-month arm) or Month 25 (for the 0, 24-month arm) following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-HPV 16 and 18 serum neutralizing antibody geometric mean titer measured by PBNA compared to ELISA at all time points (in a representative subset);Seroconversion rate, defined as a 4-fold rise in anti-HPV 16 and 18 IgG antibody as measured by ELISA, at baseline and one month following the last dose;Anti-HPV16 and 18 IgG antibody GMC measured by ELISA one month following the last dose of the Gardasil® 0-6 month two dose regimen and the Gardasil®-Cecolin® 0-24 month two dose regimen;Anti-HPV16 and 18 IgG antibody GMC measured by ELISA 24 months following the first dose of the Gardasil® 0-6 month two dose regimen and the Cecolin® 0-6 month two dose regimen;Number of subjects in each study arm reporting solicited adverse events within 7 days after each dose, Number of subjects in each study arm reporting unsolicited adverse events within one month after each dose, Number of subjects in each study arm reporting serious adverse events (SAEs) occurring at any time throughout study participation | — |
Countries
Bangladesh, Ghana
Contacts
Public ContactNiranjan Bhat
Senior Medical Officer
Outcome results
None listed