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All Drugs and Chemicals

Vaccines

9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Hansenula Polymorpha),0.5mL, three doses, 0,2,6 months

GARDASIL®9 (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) ,0.5mL, three doses, 0,2,6 months

9vHPV vaccine ,0.5mL, three doses, 0,2,6 months

Experimental: Experimental: 9-valent Human Papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)

GARDASIL®9 vaccine, 0.5mL, three doses, 0,2,6 months

Active Comparator: GARDASIL ®9

The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.

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

A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged16-26 Years

The seroconversion rate of neutralizing antibodies dected after immunization in pre-immune negative subjects from 30 days after the last dose HPV vaccine to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

To evaluate the vaccine immunogenicity is the geometric mean titer from 30 days after the last dose to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

The growth rate of GMTs of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in pre-immune positive subjects from 30 days after immunization

The seroconversion rate (4-fold increase) of anti-HPV 6, 11, 16, 18, 31, 33, 45, 52 and 58 neutralizing antibodies in subjects aged 16-26-year-old from 30 days after immunization

Adverse events reported within 30 minutes after each dose

Solicited adverse events reported between day 0 to day 7 after each dose

Unsolicited adverse events reported between day 0 to day 30 after each dose

Serious adverse events reported during the study periodfrom 1st vaccination to the completion of study

Pregnant event and pregnant outcome reported during the study period

Chongqing Bovax Biopharmaceutical Co., Ltd.

Shanghai Bovax Biotechnology Co., Ltd.

Immunologic Factors

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

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)

Participants in this arm would receive GARDASIL®

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

4-valent HPV Vaccine

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

9-valent HPV Vaccine

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

GARDASIL®

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.

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

A Randomized, Double-Blind and Positive-Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) and 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule

9-valent HPV vaccine

Huakun Lv

Person(s) responsible for the overall scientific leadership of Lv

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

This study (protocol 9-HPV-3003) is an immunogenicity and safety study in the subjects (9-19 years of age) who received the 9-valent HPV recombinant vaccine compared with the subjects (20-45 years of age). In this study, we will assess whether the immunogenicity of the 9-valent HPV vaccine given 3-dose schedule in the subjects (9-19 years of age) in noninferior to that in the subjects (20-45 years of age) receiving 3 doses, while assessing the safety of this vaccine.

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus(Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

Serious adverse events reported during the study period

The primary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the results of seroconversion rate of neutralizing antibodies after immunization in pre-immune negative subjects from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

The secondary outcome measure for assessing vaccine immunogenicity, among subjects aged between 9 and 45, is the geometric mean titer (GMT) from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

To assess vaccine immunogenicity among the subjects aged between 9 and 26, is the seroconversion rate of neutralizing antibodies and the GMT from 30 days after the last dose (3 doses schedule, Month 7) to HPV 6, 11, 16, 18, 31, 33, 45, 52 , and 58.

After receiving all 3 doses vaccinations, the subjects aged 9 to 19 years will be followed for 60 month (Month 12/24/36/48/60) after first vaccination to assess the GMT and seropositive rate (4-fold-increase) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58.

9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)

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

Yi Mo, Master

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years .

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

A Multicenter,Randomized,Blind and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 20-45 Years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females	NCT05372016	HPV Infections Cervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS	Experimental: E... Active Comparat...	16 Years - 26 Years	Shanghai Bovax Biotechnology Co., Ltd.
Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females	NCT04425291	Cervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS	4-valent HPV Va... 9-valent HPV Va... GARDASIL®	20 Years - 45 Years	Shanghai Bovax Biotechnology Co., Ltd.
Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years	NCT04895020	HPV Infections Cervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN 3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS	9-valent HPV va...	9 Years - 45 Years	Shanghai Bovax Biotechnology Co., Ltd.
Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females	NCT05372016	HPV Infections Cervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS	Experimental: E... Active Comparat...	16 Years - 26 Years	Shanghai Bovax Biotechnology Co., Ltd.
Evaluate the Efficacy, Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females	NCT04422366	Cervical Cancer Vulvar Cancer Vaginal Cancer CIN1 CIN2 CIN3 VaIN1 VaIN2 VaIN3 Genital Wart VIN 1 VIN 2 VIN 3 AIS	9-valent Human ... GARDASIL®	20 Years - 45 Years	Shanghai Bovax Biotechnology Co., Ltd.

Spots Global Cancer Trial Database for vin 1

Every month we try and update this database with for vin 1 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 vin 1

Every month we try and update this database with for vin 1 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 vin 1 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.