The primary objective of this study is to evaluate the durability of protection of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine administered in females aged 18-45 years.
This is a follow-up study that is based on phase III clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (Unique Protocol ID: HPV-PRO-003, Identifiers: NCT01735006). The investigators will recruit people who have participated in phase III clinical study on Hebei Province before and to evaluate the durability of protection of the bivalent HPV vaccine on 90m and 114m after dose 1.
Study Type
OBSERVATIONAL
Enrollment
647
The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of Subjects With CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
To observe the number of Subjects With Histopathologically-confirmed CIN2+ and/or VIN2+ and/or VaIN2+ Associated With HPV-16 and/or -18 Cervical Infection on 90m and 114m after dose 1
Time frame: expected 2-3 years
Number of Subjects With HPV-16 and/or -18 persistent cervical infection(6-month+ definition) on 90m and 114m after dose 1
To detect the HPV16 and HPV18 DNA on the gynecological specimens ( Cervical exfoliated cell specimens and biopsy specimens) collected from the subjects
Time frame: expected 2-3 years
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