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CompletedNCT04425291Updated Feb 25, 2022

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

A Phase 3 interventional study of 4-valent HPV Vaccine and 9-valent HPV Vaccine in Cervical Cancer, Vulvar Cancer and Vaginal Cancer, sponsored by Shanghai Bovax Biotechnology Co., Ltd.. Completed at 1 site in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-25.

Sponsored by Shanghai Bovax Biotechnology Co., Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
1,680
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study summary

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

02

Conditions studied

  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • CIN1
  • CIN2
  • CIN3
  • VaIN1
  • VaIN2
  • VaIN3
  • Genital Wart
  • VIN 1
  • VIN 2
  • VIN 3
  • AIS
03

In context

Condylomata Acuminata

94 studies on the registry are indexed under Condylomata Acuminata; 7 are open to participants now.

This study's enrollment of 1,680 is above the median of 140 across 77 interventional studies indexed under Condylomata Acuminata.

Browse Condylomata Acuminata studies →

Lead sponsor

Shanghai Bovax Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Chinese women aged 20-45 who can provide legal identification;
  2. The subject agreed to participate in the study, and voluntarily signs the informed consent;
  3. Subjects are able to understand the study procedures and participate in follow-up according to the study requirements;
  4. When the subjects were enrolled, the urine pregnancy test was negative, they were not in the lactation period and had no family planning within 7 months after enrollment.2 weeks before included in the study, effective contraceptive measures has been adopted and agreed to in the first seven months after the study (vaccinations after 1 months ago) continue to adopt effective contraceptive measures (effective contraceptive measures including the pill or condoms, etc );

Exclusion criteria

Exclusion Criteria:

  1. Have been vaccinated with commercially available HPV vaccine in the past or planned to be vaccinated with commercially available HPV vaccine during the study period;Or have participated in a clinical trial of the HPV vaccine;
  2. Has a history of cervical diseases, such as cervical screening showing abnormal results including CIN or a history of hysterectomy (vaginal or total abdominal hysterectomy) or pelvic radiation therapy. Has a history of genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts, vulvar cancer, vaginal cancer and anal cancer, etc.) or has a previous sexual history (including syphilis, gonorrhea, chancre, venereal lymphatic granuloma, granuloma inguinal);
  3. A history of severe allergies requiring medical intervention, such as anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc;
  4. Have an acute illness or an acute episode of a chronic illness within 3 days prior to vaccination or the use of antipyretic, analgesic and antiallergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
  5. Subjects received inactivated or recombinant vaccines within 14 days prior to study enrollment, or attenuated live vaccines within 28 days prior to study enrollment;
  6. Subjects present with immune impairment or have been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases. Long-term immunosuppressive therapy, e.g., long-term (more than 2 weeks) treatment with glucocorticoids (e.g., prednisone or similar drugs);
  7. Has been diagnosed with a severe congenital malformation or chronic disease such as Down syndrome, heart disease, liver disease, kidney disease, diabetes, etc., which may interfere with the conduct or completion of the study;
  8. Subject receives any immunoglobulin or blood product within 3 months prior to the first dose of vaccination;
  9. Participating in other (drug or vaccine) clinical trials prior to enrollment or planning to participate during the study;
  10. Has been diagnosed with an infectious disease, such as tuberculosis, viral hepatitis and/or HIV infection;
  11. A history or family history of convulsions, epilepsy, encephalopathy and mental illness;
  12. Have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy;
  13. Absence of a spleen, functional absence of a spleen, and absence or removal of a spleen in any case;
  14. Body temperature ≥37.3℃ (underarm body temperature);
  15. Subjects may be unable to comply with the study procedure, comply with the agreement, or plan to permanently relocate from the region prior to completion of the study, or may be permanently absent from the region during the scheduled visit;
  16. In the opinion of the investigators, the subjects had any other factors that made them unsuitable to participate in the clinical trial.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,680 participants (actual)

Study arms

  • Experimental
    4-valent HPV Vaccine

    Participants in this arm would receive 4-valent Human Papillomavirus (Types 6, 11, 16 and18) Recombinant Vaccine (Hansenula Polymorpha)

    Biological: 4-valent HPV Vaccine

  • Experimental
    9-valent HPV Vaccine

    Participants in this arm would receive 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

    Biological: 9-valent HPV Vaccine

  • Active comparator
    GARDASIL®

    Participants in this arm would receive GARDASIL®

    Biological: GARDASIL®

Interventions

  • Biological4-valent HPV Vaccine

    Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.

  • Biological9-valent HPV Vaccine

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

  • BiologicalGARDASIL®

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

06

What researchers measure

Primary outcomes

  1. Percentage of participants 20 to 45 Years of Age that achieve the neutralizing antibody serostatus cutoffs for seroconversion to HPV Types 6, 11, 16 and 18 at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

Secondary outcomes

  1. The neutralizing antibody GMTs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  2. Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  3. Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 6, 11, 16 and 18 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  4. The neutralizing antibody GMTs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  5. Percentage of participants that achieve neutralizing antibody quadruple growth ratefor HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  6. Percentage of participants that achieve neutralizing antibody quadruple growth rate or achieve the neutralizing antibody serostatus cutoffs for HPV Types 31, 33, 45 and 52 in participants 20 to 45 Years of Age at least 1 month post Dose 3.

    Time frame: 1 month post vaccination 3 (Month 7)

  7. Percentage of Participants Who Report at Least 1 Solicited Injection-site and Systemic Adverse Event 30 minutes post any vaccination

    Time frame: 30 minutes post any vaccination

  8. Percentage of Participants Who Report at Least 1 Solicited Adverse Event 7 days post any vaccination

    Time frame: 7 days post any vaccination

  9. Percentage of Participants Who Report at Least 1 Solicited and Unsolicited Adverse Event 30 days post any vaccination

    Time frame: 30 days post any vaccination

  10. Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) from 1st vaccination to the completion of study

    Time frame: Day 1 to 6 months post vaccination 3

  11. Percentage of Participants Who Experience Pregnancy from 1st vaccination to the completion of study

    Time frame: Day 1 to 6 months post vaccination 3

07

Study locations

1 site
  • Yangchun Center For Disease Prevention And Control
    Yangchun, Guangdong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04425291
Lead sponsor
Shanghai Bovax Biotechnology Co., Ltd.
Collaborators
Chongqing Bovax Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
May 28, 2020
Primary completion
Sep 6, 2021
Completion
Sep 6, 2021
Last update
Feb 25, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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