Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

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Skin and Connective Tissue Diseases

Uterine Cervical Neoplasms

Condylomata Acuminata

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Vaccines

Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) .

Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9 .

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

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

Gardasil®9

Jun Zhang, master

Feng-cai Zhu, master

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.

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

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

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)

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

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

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

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

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

Xiamen Innovax Biotech Co., Ltd

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Xiamen University

professor

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Gastrointestinal Agents

Aluminum phosphate

Immunologic Factors

Adjuvants, Immunologic

Antacids

Anti-Ulcer Agents

120 healthy women aged18 to 26 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil®9 : placebo =3:1:1.

120 healthy women aged 27 to 45 years are in this arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : Gardasil® : placebo =3:1:1.

Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)

SCT1000

Recombinant 9 or 4 valent human papillomavirus vaccine

placebo

Recombinant 4 valent human papillomavirus vaccine

Gardasil®

Fengcai Zhu, Master

A phase 1 random, double blind, positive and placebo control trail was conducted in 120 healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety issue. In each dose group SCT1000 : placebo: positive =3:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated, and the vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.

Arm A: 18-26 years old. Random, double blind, Gardasil®9 positive control and placebo control was conducted in 120 healthy women in the arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to receive the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. In each dose group SCT1000 : placebo: Gardasil® 9=3:1:1.Arm B: 27-45 years old. Random, double blind, Gardasil® positive control and placebo control was conducted in 120 healthy women in the arm. The first group was 40 subjects to be inoculated with low dose vaccine; After the first dose of the low dose group was completed, the safety observation was conducted 7 days after the first dose was completed. If there was no need to suspend / terminate the study, 40 subjects in the group were continued to be inoculated in the medium dose vaccine; After the first dose group was completed, the safety observation was 7 days after the first dose was completed. If there was no need to suspend / terminate the test, 40 subjects in the group were inoculated with high dose group. SCT1000 in each dose group: placebo: Gardasil® =3:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated, and the vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.

A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years

A Randomized, Double-Blind, Controlled (Positive and Placebo) Phase I Clinical Trial to Estimate Safty and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years

Occurrence of local reaction AEs up to 7 days following each dose

Occurrence of systemic AEs up to 7 days following each dose

Occurrence of AEs from dose1 to 30 days after each dose

Occurrence of SAEs from dose1 to 30 days after each dose and from dose1 to 12 months after first dose

Changes in laboratory test indicators (including white blood cell count, lymphocyte count, neutrophils, platelets, hemoglobin, ALT, AST, total bilirubin, fasting blood glucose, creatinine) 3 days after vaccination

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT04782895	Cervical Cancer Condylomata Acu...	Recombinant Hum... Gardasil®9	18 Years - 26 Years	Xiamen University
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	NCT04782895	Cervical Cancer Condylomata Acu...	Recombinant Hum... Gardasil®9	18 Years - 26 Years	Xiamen University
A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years	NCT04921111	HPV Infection V...	SCT1000 Gardasil®9 placebo Gardasil®	18 Years - 45 Years	Sinocelltech Ltd.
A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years	NCT04921111	HPV Infection V...	SCT1000 Gardasil®9 placebo Gardasil®	18 Years - 45 Years	Sinocelltech Ltd.

Spots Global Cancer Trial Database for gardasil®9

Every month we try and update this database with for gardasil®9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gardasil®9

Every month we try and update this database with for gardasil®9 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gardasil®9 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.