NCT03900572

Brief Summary

A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2019

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

March 9, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

March 28, 2019

Last Update Submit

April 12, 2023

Conditions

HPV Infections

Keywords

Human Papilloma VirusPapillomavirus vaccinesCervical CancerGenital Warts

Outcome Measures

Primary Outcomes (4)

  • Percentage of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed including pain, redness, swelling, induration and itching.

    During a 8-day period (Day 0-7) following each vaccination

  • Percentage of Subjects Reporting Solicited General Symptoms

    Solicited general symptoms assessed including fever, headache, fatigue, nausea, diarrhea, vomiting, myalgia, allergic reaction

    During a 8-day period (Day 0-7) following each vaccination

  • Percentage of Subjects Reporting Unsolicited Adverse Events (AEs)

    An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study.

    Within 31 days (Day 0-30) after any vaccination

  • Percentage of Subjects Reporting Serious Adverse Events (SAE)

    Serious adverse events are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Throughout the study period (up to Month 12)

Secondary Outcomes (2)

  • Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58

    30 days after the third dose (Month 7)

  • Geometric Mean Titers (GMT) of HPV serotype-specific antibody

    30 days after the third dose (Month 7)

Study Arms (2)

HPV vaccine

EXPERIMENTAL

Subjects receive 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.

Biological: HPV Vaccine

Placebo

PLACEBO COMPARATOR

Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.

Drug: Placebo

Interventions

HPV VaccineBIOLOGICAL

Intramuscular injection, 3 doses

HPV vaccine
PlaceboDRUG

Intramuscular injection, 3 doses

Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy females, 9 to 45 years old (inclusive).
  • to 17 years old participants: able to prove their identities and provide their legal guardians' identity information.
  • Legal guardians of the 9 to 17 years old participants: able to understand (not illiterate) and agree to co-sign the informed consent forms with participants
  • to 45 years old participants: able to prove their legal identities.
  • to 45 years old participants: able to understand (not illiterate) the study and agree to sign the informed consent form.
  • Child bearing age participants: agree not to become pregnant by using proper contraception means in the 7-month study period.

You may not qualify if:

  • History of cervical cancer or genital warts.
  • History HPV vaccination or history of participation in HPV vaccine trial.
  • History of severe allergy which needs medical intervention such as swelling of the mouth and throat, difficulty breathing, hypotension or shock.
  • Skin abnormality at injection site including inflammation, sclerosis, redness, swelling, and extensive scars.
  • History of allergy to vaccine or vaccine components including aluminum phosphate, histidine and Polysorbate 80, and severe adverse reactions in past vaccination.
  • Medical history of epilepsy, convulsions, seizures , or family history of mental illness.
  • Medical conditions including immunocompromised or diagnosed as congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases and received immunosuppressants in 6 months prior to first vaccination.
  • History of asthma, thyroidectomy, angioneurotic edema, diabetes, and malignancy.
  • Asplenia, functional asplenia, or any circumstances as a result of asplenia or splenectomy
  • Diagnosis as coagulation abnormalities such as clotting factor deficiency, platelet abnormalities or having significant bruising, or coagulation disorder
  • Being diagnosed with acute illnesses or acute onset of chronic illness during the last 3 days.
  • Treatment with immunoglobulins or other blood-derived products within 3 months prior to Day 0 vaccination.
  • Having received subunit or inactivated vaccine within 14 days prior to Day 0 vaccination or received attenuated vaccine within 28 days prior to Day 0 vaccination.
  • Fever before vaccine administration with axillary temperature higher than 37.0°C.
  • Currently breastfeeding, and being pregnant including pregnancy test positive.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial Center for Disease Prevention and Control

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical NeoplasmsCondylomata Acuminata

Interventions

Papillomavirus Vaccines

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 ComplicationsWartsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Xuecheng LIU, BS

    Sichuan Provincial Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 3, 2019

Study Start

March 9, 2019

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

CN(1)