NCT03206255

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

87
On Track

Trial Health Score

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

Enrollment
940

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

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

June 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

June 30, 2017

Last Update Submit

January 3, 2019

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 Months 18 and 30 (type specific IgG antibody)

    To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on 18 and 30 months after the dose 1

    Month 18 and 30

Secondary Outcomes (2)

  • Anti-HPV16 and anti-HPV18 seroprevalence and geometric mean concentrations at Months 18 and 30 (type specific neutralizing antibody)

    Month 18 and 30

  • All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded

    between 7 months and 30months after the dose1

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

Procedure: 3 doses of HPV 16/18 bivalent vaccine

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

Procedure: 2 doses of HPV 16/18 bivalent vaccine

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

Procedure: 3 doses of HPV 16/18 bivalent vaccine

Interventions

3 doses of HPV 16/18 bivalent vaccinePROCEDURE

Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)

18-26y (0,1,6m)9-17y (0,1,6m)
2 doses of HPV 16/18 bivalent vaccinePROCEDURE

Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

9-14y (0,6m)

Eligibility Criteria

Age10 Years - 28 Years
Sexfemale
Healthy VolunteersYes
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-006-2, 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-006-2, Identifiers: NCT02562508) and received at least one dose;
  • The legal guardian of participants under age 18 can provide identity certificate, or representative can provide authorization;
  • Participants under the age 18, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18 and older agree to sign the written informed consent;
  • 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;

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

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

Study Officials

  • Ting Wu, Ph. D.

    Xiamen University

    STUDY CHAIR

  • Yuemei Hu, Bachelor

    Jiangsu Provincial Centre for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

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

June 30, 2017

First Posted

July 2, 2017

Study Start

July 1, 2017

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

CN(1)