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RecruitingNCT05371353Updated Apr 17, 2024

Immune Persistence After the Whole Vaccination Shcedule With Recombination Quadrivalent HPV Vaccine

An observational study in HPV Infections, Cervical Cancer Stage IIa and Vaginal Cancer, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Recruiting at 2 sites in China. Open to female participants aged 9 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
600
Ages
9 Years to 45 Years
Sex
Female
01

Study summary

To access the immune persistence of Chinese women aged 9-45 years after receiving quadrivalent HPV vaccine with the immunization schedule of 0, 2 and 6 months.

02

Conditions studied

  • HPV Infections
  • Cervical Cancer Stage IIa
  • Vaginal Cancer
  • Genital Wart
  • CIN1
  • CIN2
  • CIN3

Keywords

  • Human papillomavirus
  • vaccine
  • Cervical Cancer
03

In context

Papillomavirus Infections

505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.

This study's planned enrollment of 600 is above the median of 400 across 151 observational studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects aged 9-45 years old have completed receiving three doses of quadrivalent HPV vaccine and provided blood sample at month 7

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
  • The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
  • The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
  • Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion criteria

Exclusion Criteria:

  • Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
  • Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
  • According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Seroconversion rate (SCR) for Each of the HPV Types Contained in the Vaccine

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

    Time frame: Month 12

  2. SCR for Each of the HPV Types Contained in the Vaccine

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

    Time frame: Month 24

  3. SCR for Each of the HPV Types Contained in the Vaccine

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

    Time frame: Month 36

  4. SCR for Each of the HPV Types Contained in the Vaccine

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

    Time frame: Month 48

  5. SCR for Each of the HPV Types Contained in the Vaccine

    The primary immue persistence outcome to evaluate respinses quadrivalent HPV vaccine was Year 5 seroconversion rate against HPV-types 6,11,16, and 18

    Time frame: Month 60

  6. Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

    Time frame: Month 12

  7. GMTs for Each of the HPV Types Contained in the Vaccine

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

    Time frame: Month 24

  8. GMTs for Each of the HPV Types Contained in the Vaccine

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

    Time frame: Month 36

  9. GMTs for Each of the HPV Types Contained in the Vaccine

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

    Time frame: Month 48

  10. GMTs for Each of the HPV Types Contained in the Vaccine

    The primary immune persistence endpoint is anti-HPV type 6,11,16,and 18 antibody GMTs 5 years post dose 1 assessed among the subjects who were seropositive at Month 7

    Time frame: Month 60

07

Study locations

2 of 2 sites recruiting
  • Yangchun Center For Disease Prevention And Control
    Yangchun, Guangdong, China
    Recruiting
  • Center for Disease Control and Prevention
    Mianyang, Sichuan, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05371353
Lead sponsor
Shanghai Bovax Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
May 12, 2022
Start date
May 14, 2022
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Apr 17, 2024

Study contacts

Jikai Zhang
Contact
56061237@qq.com
020-89020236
Jikai Zhang
study director · Guangdong Center for Disease Prevention and Control

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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