Healthy female adolescents will be vaccinated with nonavalent human papillomavirus vaccine. HPV vaccine Recombinant vaccine Immunogenicity
Conditions
Interventions
140 participants will receive 1 dose of Cecolin9.,140 participants will receive 1 dose of Gardasil9.,140 participants will receive 2 doses of Cecolin9.
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine
1 dose Cecolin9,1 dose Gardasil9,2 doses Cecolin9
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
Female
Age
9 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female aged 9 to <15 years at the time of enrolment. 2. Never received HPV vaccination. 3. The participant has signed and dated an assent/consent form, and parent or legally authorized representative (LAR) has signed and dated an informed consent form. 4. Participant who can adhere to the study procedures without relocation plan in the duration of study.
Exclusion criteria
Exclusion criteria: 1. History of allergy or hypersensitivity to any components of the trial vaccines (Cecolin 9 or Gardasil 9). 2. Receipt of immunoglobulins or any blood products within 3 months prior to enrolment or plan to receive during the study. 3. Bleeding disorder that contraindicates intramuscular vaccination. 4. Receipt of any vaccines within 28 days (for live vaccines) or 14 days (for inactivated vaccines) before or after receipt of study vaccine. 5. Impairment/alteration of immunological function. 6. Use of systemic steroids or immunosuppressive therapy for >14 days within 3 months prior to enrolment or plan to receive during the study. The use of inhaled, nasal, or topical steroids is allowed. 7. Previous HPV-associated cancer or precancerous lesion. (Prior screening is not required for eligibility assessment.) 8. Pregnant or breastfeeding. 9. Participating in any clinical trial involving investigational product within 30 days prior to enrolment or plan to participate during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity to HPV-16, 18, 31, 33, 45, 52, 58 Month 24 pseudovirus-based neutralization assay (PBNA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity to HPV-16, 18, 31, 33, 45, 52, 58 Month 0, 1, 7, 12 pseudovirus-based neutralization assay (PBNA),Immunogenicity to HPV-6, 11 Month 0, 1, 7, 12, 24 pseudovirus-based neutralization assay (PBNA),Safety Entire study period Adverse events | — |
Countries
Thailand
Contacts
Public ContactProf. Thanyawee Puthanakit
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed