NCT02740790

Brief Summary

Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

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

Study Start

First participant enrolled

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

February 18, 2016

Last Update Submit

April 12, 2023

Conditions

Human Papillomavirus

Keywords

Human papillomavirusvaccinecervical infectioncervical cancer

Outcome Measures

Primary Outcomes (1)

  • The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT).

    1 month after vaccination

Secondary Outcomes (3)

  • Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions

    7 days after each vaccine dose

  • Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions

    6 months after finish vaccinations

  • The durability of neutralizing antibody responses of HPV 16/18 after vaccination.

    48 months after finish vaccinations

Study Arms (6)

HPV vaccine 1

EXPERIMENTAL

300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines

Biological: HPV vaccine

Placebo 1

PLACEBO COMPARATOR

300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule Placebo.

Biological: Placebo

HPV vaccine 2

EXPERIMENTAL

120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines

Biological: HPV vaccine

HPV vaccine 3

EXPERIMENTAL

180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines

Biological: HPV vaccine

Placebo 2

PLACEBO COMPARATOR

120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule Placebo.

Biological: Placebo

Placebo 3

PLACEBO COMPARATOR

180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule Placebo.

Biological: Placebo

Interventions

HPV vaccineBIOLOGICAL

Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule

HPV vaccine 1HPV vaccine 2HPV vaccine 3
PlaceboBIOLOGICAL

Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule

Placebo 1Placebo 2Placebo 3

Eligibility Criteria

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

You may qualify if:

  • Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination
  • Provide legal identification for for the sake of recruitment
  • Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition).
  • Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months.

You may not qualify if:

  • History of cervical cancer
  • Previous administration of any HPV vaccine
  • History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
  • History of allergic to vaccine, or to any ingredient of vaccine.
  • History of epilepsy, seizures or convulsions, or family history of mental illness
  • Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
  • History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant
  • Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
  • Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
  • Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
  • Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days.
  • Fever or axillary temperature\> 37.0 °C before vaccination
  • During menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month
  • History of hypertension, physical examination systolic blood pressure\> 150mmHg and/or diastolic blood pressure\> 100mmHg
  • Abnormal laboratory tests parameters
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GuangXi Center for Diseases Control and Prevention

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Rong-cheng Li, MD

    Guangxi Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

April 15, 2016

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2017

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)