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OpenTrials
Completed

NCT Number: NCT04782895

Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

This study is designed to compare the immunogenicity of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is female, between and including 18-26 years of age at the first vaccination;
  • Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, completion of the diary cards, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;
  • Subject who agrees to practice effective contraception within 8 months after the first vaccination or has undergone tubal ligation,subtotal hysterectomy for benign lesion, ovarian benign tumor resection;
  • No previous history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, venereal lymphogranuloma, groin granuloma, etc.);
  • No previous history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN);

Exclusion criteria

  • Axillary temperature > 37.0℃;
  • Subject who has a positive urine pregnancy test, or is pregnant or breastfeeding;
  • Subject has used of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine or plans to use during the study period , or has participated in another clinical research in the past two years, or plans to participate in another research during the study period;
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or systemic corticosteroids (Except intranasal steroid, the use of low dose topical, ophthalmic and inhaled steroid preparations will be permitted.) within 6 months prior to vaccination.
  • Administration of immunoglobulin and/or blood products within 3 months prior to vaccination or planned to use them within 7 months after the first dose.
  • Administration of inactivated vaccine within 14 days prior to vaccination or live vaccine within 21 days;
  • Fever (Axillary temperature ≥38.0℃) 3 days prior to vaccination or system administration of antibiotics or antiviral agents within 5 days prior to vaccination;
  • Subject has received other HPV vaccines or participated in clinical research related to HPV or cervical cancer previously;
  • Subject has immunodeficiency disease, primary disease of important viscera, cancer and autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy due to any condition, and other immunological diseases that investigators believe may influence the immune response).
  • History of severe allergy (e.g., anaphylaxis, generalized urticaria, dyspnea, angioedema, and other significant reaction) to any previous vaccination, or be allergic to any of the components of the study vaccines.
  • Asthma, which has been unstable for the past two years and requires emergency treatment, hospitalization, oral or intravenous corticosteroids;
  • Subject has Serious medical disorders;
  • Self-report coagulation disorders or abnormal coagulation function;
  • Epilepsy, excluding febrile epilepsy under 2 years of age, alcoholic epilepsy 3 years prior to abstinence or simple epilepsy that does not require treatment in the past 3 years;
  • Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Treatment and study plan

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Biological

Three doses administered intramuscularly at 0, 45 day and 6 month.

GARDASIL®9

Biological

Three doses administered intramuscularly at 0, 45 day and 6 month.

Primary outcomes

  1. Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level

    Time frame: 7 months after the first dose

    Anti-HPV 6,11,16,18,31,33,45,52 and 58 seroconversion rates and geometric mean concentrations at months 7

Secondary outcomes

  1. safety1:Local and systematic adverse events/reactions occurred within 7 days after each vaccination.

    Time frame: During the 7-day period following each vaccination

    Local and systematic adverse events/reactions occurred within 7 days after each vaccination.

  2. safety2:Adverse events/reactions occurred within 30 days after each vaccination.

    Time frame: Within 30 days (Day 0-30) after any vaccination

    Adverse events/reactions occurred within 30 days after each vaccination.

  3. safety3:Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.

    Time frame: Up to 8 month

    Severe adverse events occurred throughout the study. To evaluate number of SAEs compared with the control vaccine.

  4. safety4:Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.

    Time frame: Up to 8 month

    Pregnancy and pregnancy outcome. To evaluate number of births and terminations compared with the control vaccine.

Other outcomes

  1. Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific IgG antibody level

    Time frame: 7 months after the first dose

    Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at months 7(type specific IgG antibody)

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
  • Xiamen Innovax Biotech Co., Ltd

Registry information

Official study title

A Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck & Co., Inc.) in Healthy Females 18-26 Years of Age

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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