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Vaccines

0.5 mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

0.5-mL suspension for injection, each 0.5-mL dose contains approximately 30 mcg of HPV Type 6 L1 protein, 40 mcg of HPV Type 11 L1 protein, 60 mcg of HPV Type 16 L1 protein, 40 mcg of HPV Type 18 L1 protein, 20 mcg of HPV Type 31 L1 protein, 20 mcg of HPV Type 33 L1 protein, 20 mcg of HPV Type 45 L1 protein, 20 mcg of HPV Type 52 L1 protein, and 20 mcg of HPV Type 58 L1 protein.

9-19 years group (3 doses) and 20-26 years group (3 doses) will be vaccinated at months 0, 2, 6. 9-14 years group (2 doses) will be vaccinated at months 0, 6.

Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli)

20-26 years possitive control group will be vaccinated at months 0, 2 and 6

GARDASIL® 9

Yongjiang Liu, Bachelor

The study is to evaluate immune response induced by 9-valent HPV study vaccine is non-inferior to those induced by GARDASIL® 9 administrated with 3-dose schedule in female participants aged 20-26 years in China, if the immune response induced with same conditions in 9-19 age group is non-inferior to 20-26 age group, and if the immune response induced by 9-valent HPV study vaccine administrated with 2-dose schedule in females aged 9-14 years is non-inferior to 3-dose schedule in females aged 20-26 years.

This is a parallel-controlled study. A total of 2,750 participants will be enrolled in this study: 9-14 years (2 doses) group and 9-19 years (3 doses) group are of non-randomized, open label design; 20-26 years (3 doses) group will be randomized and blinded.

9-14 age group and group 9-19 age group will be enrolled in two stages: 20 subjects in 9-19 age group will be enrolled first. After assessing the safety data (including laboratory test data) within 7 days of 1st dose vaccination in these 20 subjects, and if the suspension criteria are not met, the remaining 620 subjects in 9-19 age group and 640 subjects in 9-14 age group will be enrolled subsequently. 20-26 age group will be enrolled directly, with no stage entry requirements. Eligible subjects will be enrolled to received vaccines accordingly. Subjects who have reached menarche will undergo urine pregnancy test prior to each dose of vaccination (on the vaccine day.)

A total of 2,750 participants were enrolled in this study: 9-14 years (2 doses) group was administrated with investigational vaccine on 0 Day, 6th month, and 9-19 years (3 doses) group was administrated with investigational vaccine on 0 Day, 2nd month and 6th month. Both of these two group are of non-randomized, open label design; 20-26 years (3 doses) group was randomized at a 1: 1 ratio to receive the investigational vaccine or the positive control, respectivelyon 0 Day, 2nd month and 6th month.

The Sponsor, investigators and biostatisticians will remain blinded to subject allocation.

A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China

A Parallel-controlled Study to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in Healthy Female Participants Aged 9-26 Years in China

No informed consent was obtained to disclose the subject's data and sample test results

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group.

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: aged 9-14 years (2 doses) group, aged 9-19 years (3 doses) group and aged 20-26 years (3 doses) group

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination, for participants in study vaccine group: 9-14 years (2 doses) group, 9-19 years (3 doses) group, and participants in control vaccine group: 20-26 years (3 doses) group

GMT of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.

SCR of anti-HPV 6/11/16/18/31/33/45/52/58 specific IgG antibodies assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination for all participants.

GMT of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.

SCR of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) at 12 months, 24 months, 36 months, 48 months, 60 months and 72 months after first vaccination for all participants.

First 20 subjects enrolled in 9-19 years group: abnormality rate of laboratory test on Day 3 after each dose of vaccination.

Follow up 30 minutes observation after injection to collect the Incidence, intensity, and duration of AEs within 30 minutes after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of solicited (local and systemic) AEs which within 7 days after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to Incidence, intensity, and duration of unsolicited AEs which within 30 days after each dose of vaccination for all participants

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of SAE which within 72 months after first vaccination for all participants.

Collect the Safety follow up Dairy Card (questionnaires) to gather the information related to incidence, intensity, and duration of the occurrence of pregnancy events which within 72 months after first vaccination for all participants

Yunnan Center for Disease Control and Prevention

Mile City Center for Disease Control and Prevention

Qiubei County Center for Disease Control and Prevention

Yanshan County Center for Disease Control and Prevention

National Institutes for Food and Drug Control, China

Shanghai Stem Pharmaceutical Development Co., Ltd.

Beijing Health Guard Biotechnology, Inc

Immunologic Factors

Study vaccine: Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) (Hereinafter referred to as "Nonavalent HPV study vaccine")

Provided by: Beijing Health Guard Biotechnology, Inc.

Dosage: 0.5 mL per dose

Appearance: White, cloudy liquid suspension

Dosage form: 0.5-mL suspension for injection as a prefilled syringe

Route of administration: Intramuscular injection into the lateral deltoid muscle of the upper arm

Vaccination schedule in this study：3 injections on a 0, 2, 6-month schedule.

Control vaccine: GARDASIL® 9

Manufacturer: Merck Sharp and Dohme Corp (MSD).

Dosage: 0.5 mL per dose

Appearance: After thorough agitation, GARDASIL® 9 is a white cloudy liquid

Dosage form: 0.5-mL suspension for injection as a prefilled syringe

Route of administration: Intramuscular injection into the lateral deltoid muscle of the upper arm

Vaccination schedule：3 injections on a 0, 2, 6-month schedule.

A 3-dose regimen administered at months 0, 2 and 6.

Nonavalent HPV study vaccine

Yu Hongyang

This Study to Evaluate the Immunogenicity and Safety of Candidate Recombinant Nonavalent (types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia coli) Administered Intramuscularly in Healthy Female Participants Aged 18 to 45 Years

This is a randomized, observer blinded, active controlled, multicenter clinical study.

A total of approximately 1,260 healthy female participants aged 18 to 45 years old who meet eligibility will be enrolled, and be randomly assigned into 2 groups in a 1:1 ratio.

Immunogenicity: Blood samples (5.0 mL each time) will be collected for all participants prior to the 1st dose of vaccination and on 1, 6, 12, 18 months after full vaccination for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and Immunoglobulin G antibodies testing.

Safety evaluation (for all participants):To assess solicited (local and systemic) Adverse Event (AEs) within 7 days after each dose of vaccination, unsolicited Adverse Event (AEs) within 30 days after each dose of vaccination, and Serious Adverse Event (SAEs) from 1st dose to 18 months after full vaccination.

Collection of pregnancy events:To assess the occurrence of pregnancy events in all participants from 1st dose to 18 months after full vaccination. The subject will be followed to determine the outcome of the pregnancy.

At the end of the pregnancy, be it a full-term or premature birth, information on the status of the newborn(s) will be followed up during the first 12 months of life.

The Sponsor, investigators and biostatisticians will remain blinded to subject allocation

A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine

A Phase III Trial in Healthy Indonesian Women Ages 18-45 to Evaluate the Immunogenicity and Safety of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli)

Geometric mean titer (GMT) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

Seroconversion Rate (SCR) for anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies (pseudo-virus neutralizing assay) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 immunoglobulin G antibodies as assessed by enzyme-linked immunosorbent assay (ELISA) 30 days after full vaccination in participants who are seronegative to the relevant HPV type prior to 1st vaccination.

Geometric mean titer (GMT) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.

Seroconversion Rate (SCR) of anti-HPV type 6/11/16/18/31/33/45/52/58 neutralizing antibodies and immunoglobulin G antibodies 6 months, 12 months and 18 months after full vaccination in participants.

Incidenct, severity and duration of each solicited (local and systemic) AE within 7 days after each dose of vaccination.

Incidenct, severity and duration of each unsolicited AE within 30 days after each dose of vaccination.

Incidence, severity and causality of SAE and incidence of pregnancy events from 1st dose to 18 months after full vaccination.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China	NCT05662020	Human Papilloma...	Recombinant Non... GARDASIL® 9	9 Years - 26 Years	Beijing Health Guard Biotechnology, Inc
A Study to Evaluate the Immunogenicity and Safety of Nonavalent Human Papillomavirus (HPV) Vaccine	NCT06207175	Human Papilloma...	Nonavalent HPV ... GARDASIL® 9	18 Years - 45 Years	Beijing Health Guard Biotechnology, Inc

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