NCT05262010

Brief Summary

A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
13,500

participants targeted

Target at P75+ for phase_3

Timeline
25mo left

Started Jun 2022

Longer than P75 for phase_3

Geographic Reach
1 country

8 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 Progress66%
Jun 2022Jun 2028

First Submitted

Initial submission to the registry

January 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 4, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

January 16, 2026

Status Verified

December 1, 2025

Enrollment Period

6 years

First QC Date

January 27, 2022

Last Update Submit

January 15, 2026

Conditions

HPV InfectioNHPV-Related Carcinoma

Keywords

HPV Infection HPV vaccine

Outcome Measures

Primary Outcomes (2)

  • Person-years incidence of CIN2+ associated with HPV6/11/16/18.

    1 month after 3 doses of vaccine

  • Person-years incidence of CIN2+ associated with HPV31/33/45/52/58/59/68

    1 month after 3 doses of vaccine

Secondary Outcomes (15)

  • Person-years incidence of PI12 and PI6 associated with HPV6/11/16/18 types.

    1 month after 3 doses of vaccine

  • Person-years incidence of PI12 and PI6 associated with HPV31/33/45/52/58

    1 month after 3 doses of vaccine

  • Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68 types associated with CIN2+, CIN1+, PI12 and PI6

    1 month after 3 doses of vaccine

  • Person-years incidence of HPV6/11/16/18/31/33/45/52/58/59/68-associated anogenital and vaginal lesions (including: genital warts, VIN1+, VaIN1+, and AIN1+).

    1 month after 3 doses of vaccine

  • Person-years incidence of CIN2+, PI12 and PI6 associated with HPV6/11/16/18

    After at least 1 dose of vaccine

  • +10 more secondary outcomes

Other Outcomes (2)

  • Person-years incidence of PI12 and PI6 associated with HPV59/68

    1 month after 3 doses of vaccine

  • Person-years incidence of PI12 and PI6 associated with HPV59/68

    1 month after 1 doses of vaccine

Study Arms (2)

experiment group

EXPERIMENTAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

Biological: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)

placebo

PLACEBO COMPARATOR

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

Biological: placebo

Interventions

11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)BIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine

experiment group
placeboBIOLOGICAL

According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- non-gynecological related
  • \*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
  • \*Axillary body temperature \<37.3℃ on the day of enrollment;
  • The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
  • Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
  • No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
  • The subject has a negative urine pregnancy test on the day before vaccination.
  • \- Gynecology related
  • \*Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
  • \*Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina）, no vaginal drugs or preparations are used.

You may not qualify if:

  • (Visits may be rescheduled if the criteria described in the "\*" option are met at screening)
  • \- Non-gynecological related
  • \* Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
  • \*3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
  • \*Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
  • \*3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
  • History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
  • Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
  • month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
  • Previous splenectomy or impaired spleen function;
  • Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
  • Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
  • Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
  • Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
  • The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hechi Yizhou District Center for Disease Control and Prevention

Hechi, Guangxi, 546300, China

NOT YET RECRUITING

Hezhou Center for Disease Control and Prevention

Hezhou, Guangxi, 542899, China

NOT YET RECRUITING

Lianyuan Center for Disease Control and Prevention

Lianyuan, Hunan, 417100, China

RECRUITING

Qiyang Center for Disease Control and Prevention

Wuxi, Hunan, 426100, China

RECRUITING

Yongji Center for Disease Control and Prevention

Yongji, Shanxi, 044500, China

NOT YET RECRUITING

Yuanqu Center for Disease Control and Prevention

Yuncheng, Shanxi, 043700, China

NOT YET RECRUITING

Mianyang Youxian District Center for Disease Control and Prevention

Mianyang, Sichuan, 621000, China

NOT YET RECRUITING

Neijiang Shizhong District Center for Disease Control and Prevention

Neijiang, Sichuan, 641000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Zhaojun Mo

CONTACT

（+86）15177771508mozhj@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

March 2, 2022

Study Start

June 4, 2022

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

January 16, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(8)