ザンビアにおける9歳から14歳の少女および少年ならびに15歳から20歳の少女・女性を対象とした、CERVAVAC® 4価HPVワクチンの単回投与とGardasil® 4価ワクチンの免疫原性の非劣性を確立するための、無作為化、活性対照、評価者盲検試験 (CervALONE)

Inclusion Criteria:

1. Girl/woman between 9 and 20 years of age and boy between the age of 9 and 14 years at the time of recruitment.
2. Participant willing to sign a written informed consent (for participants 18 years of age and above).
3. Parent (s) willing to provide written informed consent and participant is willing to sign written assent form for participation (for participants below 18 years of age at the time of eligibility assessment).
4. Participant or parent (s) willing to comply with all study requirements.
5. Participants who are determined by Medical History (MH), Physical Examination (PE) and clinical judgment of the Investigator to be eligible for inclusion in the study.

Exclusion Criteria:

1. Participants who are sexually active and missed their last menstrual period will have a urine pregnancy test and will be excluded if found pregnant.
2. Participant has a known history of prior vaccination with any HPV vaccine.
3. Participant known to be HIV positive (no routine HIV testing will be performed unless clinically indicated)
4. Participant currently enrolled in any other clinical studies of investigational products.
5. Participant with a current diagnosis or prior history of genital warts or treatment of genital warts.
6. Participant with a current diagnosis or prior history of cervical intraepithelial neoplasia (CIN) or cervical cancer.
7. Participant has a history of any allergic diseases or severe allergic reaction to any agent/vaccine product (e.g., swelling of the mouth and throat, difficulty in breathing, hypotension, or shock).
8. Participant has had an acute illness (moderate or severe) and/or fever (body temperature ≥ 38°C or ≥ 100.4 °F) at the time of vaccination or during the 72 hours prior to the vaccination.
9. Bleeding diathesis or uncontrolled condition associated with prolonged bleeding that would, in the opinion of the Investigator, contraindicate IM injection.
10. Participant has history of major congenital defects or illness that requires medical therapy, as determined by MH or clinical assessment.
11. Participant has had chronic administration (defined as more than 14 days) of high doses of corticosteroids (prednisone or equivalent at a dose of >0.5 mg/kg/day), cytotoxic agents or radiotherapy or immunoglobulins, immunosuppressants or other immune-modifying drugs in last 3 months or planned at any time during the study.
12. Participant has history of receiving a blood transfusion or other blood products in three months prior to screening.
13. Planned administration of a vaccine not foreseen by the study protocol within 14 days before and 14 days after any dose of study vaccine except TT given for emergency use and any vaccine mandated by government program.
14. Participant has history of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia or any condition which in the opinion of the Investigator might interfere with the evaluation of the study objectives.
15. Participant has history of any cancer, organ transplant or any other immune system disease.
16. Individuals who, in the opinion of the investigator, are unlikely to be compliant to all study procedures