NCT05371353

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
May 2022May 2027

First Submitted

Initial submission to the registry

May 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 14, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 years

First QC Date

May 4, 2022

Last Update Submit

April 15, 2024

Conditions

HPV InfectionsCervical Cancer Stage IIaVaginal CancerGenital WartCIN1CIN2CIN3

Keywords

Human papillomavirusvaccineCervical Cancer

Outcome Measures

Primary Outcomes (10)

  • 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

    Month 12

  • 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

    Month 24

  • 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

    Month 36

  • 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

    Month 48

  • 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

    Month 60

  • 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

    Month 12

  • 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

    Month 24

  • 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

    Month 36

  • 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

    Month 48

  • 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

    Month 60

Eligibility Criteria

Age9 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yangchun Center For Disease Prevention And Control

Yangchun, Guangdong, China

RECRUITING

Center for Disease Control and Prevention

Mianyang, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical NeoplasmsVaginal NeoplasmsCondylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsVaginal DiseasesWartsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jikai Zhang

    Guangdong Center for Disease Prevention and Control

    STUDY DIRECTOR

Central Study Contacts

Jikai Zhang

CONTACT

020-8902023656061237@qq.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 12, 2022

Study Start

May 14, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations

CN(2)