NCT04704908

Brief Summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
979

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

February 6, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 7, 2021

Last Update Submit

January 24, 2023

Conditions

Cervical Intraepithelial NeoplasiaCervical CancerVaginal Intraepithelial NeoplasiaVulvar Intraepithelial NeoplasiaPersistent Infection

Keywords

Human Papilloma Virus 16Human Papilloma Virus 18adolescent girlnon-inferiorityimmuno-persistence

Outcome Measures

Primary Outcomes (1)

  • Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type-specific IgG antibody)

    To detect the anti-HPV 16 and anti-HPV 18 type-specific IgG antibody level on 54 month after the dose 1

    Month 54

Secondary Outcomes (1)

  • Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Month 54 (type specific neutralizing antibody)

    Month 54

Study Arms (3)

9-17y (0,1,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Drug: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

9-14y (0,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine

Drug: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

18-26y (0,1,6m)

Participants in this arm have received 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine

Drug: Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)DRUG

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

Also known as: There is no other Intervention in this study
18-26y (0,1,6m)9-14y (0,6m)9-17y (0,1,6m)

Eligibility Criteria

Age14 Years - 32 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants who participated in the bridging study (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose will be recruited.

You may qualify if:

  • Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose;
  • Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
  • Able to comply with the requests of the study;

You may not qualify if:

  • Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
  • According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
  • Abnormal blood clotting function or coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical NeoplasmsPersistent Infection

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Ting Wu, Ph. D.

    Xiamen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

February 6, 2021

Primary Completion

April 1, 2021

Study Completion

December 1, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

CN(1)