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Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years
To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.
Details
| Lead sponsor | Shanghai Zerun Biotechnology Co.,Ltd |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 900 |
| Start date | 2016-02 |
| Completion | 2019-07 |
Conditions
- Human Papillomavirus
- Cervical Intraepithelial Neoplasia
- Persistent Infection
Interventions
- HPV-16/18 vaccine
Primary outcomes
- HPV-16 and HPV-18 antibody titers (GMT) — one month after the final injection
Compare the HPV-16 and HPV-18 specific antibody titers (GMT) between the 2-dose immunization schedule (0, 6 months) in adolescent females aged 9 to 14 years and the 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.
Countries
China