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| Name | Class |
|---|---|
| Xiamen Innovax Biotech Co., Ltd | INDUSTRY |
| Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. | INDUSTRY |
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This phase III clinical study was designed to evaluate the efficacy,immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli) manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women aged 18-45 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV vaccine (6,11,16,18,31,33,45,52,58 Types) | Experimental | Participants in this arm would receive 270μg/0.5ml HPV vaccines (6,11,16,18,31,33,45,52,58 Types). |
|
| HPV vaccine (16,18 Types) | Active Comparator | Participants in this arm would receive 60μg/0.5ml HPV vaccines (16,18 Types). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nonavalent HPV vaccine | Biological | Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-inferiority of anti-HPV 16 and 18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) in the PPS-I set | Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the third dose to determine whether nine-valent HPV vaccine is non-inferior to the control bivalent HPV vaccine | Specific neutralizing antibodies at 7 months after first dose |
| Persistent infection of HPV31, 33, 45, 52 and 58 (over 12 months) (Combined analysis of the 5 types) in the mITT-PI set | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58 (Combined analysis of the 5 types) in the mITT-E when the first two endpoints are satisfied | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy1: Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CIN2 + and/or VIN2 + and/or VaIN2 + lesions related to HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68 (Combined analysis of the high risk types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, master | Xiamen University | Study Chair |
| Hong-xing Pan, master | Jiangsu Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Centre for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China | ||
| Sichuan Provincial Centre for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42379209 | Derived | Pan HX, Bi ZF, Jing YL, Hu SY, Zhang L, Zhu KX, Chu K, Hong Y, Chang SF, Pan QJ, Zhang X, Xu JB, Tang J, Yuan DY, Jiang H, Du C, Sun G, Zhong GH, Chen Q, Wei LH, Qiao YL, Li SW, Su YY, Zhang QF, Huang SJ, Zhao FH, Huang WJ, Wu T, Zhang J, Xia NS. Efficacy, safety, and immunogenicity of an Escherichia coli-produced nine-valent human papillomavirus vaccine: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2026 Jun 30:S1473-3099(26)00221-5. doi: 10.1016/S1473-3099(26)00221-5. Online ahead of print. |
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| Bivalent HPV vaccine | Biological | Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule. |
|
| Efficacy2: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) and genital warts related to HPV 6, 11 (Combined analysis of each type) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy3: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (transient infection and over 6 months) (Combined analysis of the 5 types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy4: Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy5: Incidence of Persistent infection of HPV31, 33, 45, 52 and 58 (over 6 months) and/or incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 31, 33, 45, 52 or 58(Combined analysis of the 5 types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy6: Incidence of genital warts related to HPV 6, 11 | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy7: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (transient infection and over 6 months and over 12 months) (Combined analysis of the 7 types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Efficacy8: Incidence of Persistent infection of HPV31, 33, 45, 52, 58, 6 and 11 (over 6 months and over 12 months) (Independent analysis of each type) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 7 | Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types. | Month 7 after first vaccination |
| Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 18 and 30 | Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types. | Month 18 and 30 after first vaccination |
| Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 seroconversion rates and geometric mean concentrations at Months 42, 54, 66 and 78 | Analysis the seroconversion and geometric mean concertration of the type specific antibodies of the 7 types. | Month 42, 54, 66 and 78 after first vaccination |
| Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination | safety analysis | During the 7-day (Day 0-6) period following each vaccination |
| Safety2: Adverse events/reactions occurred within 30 days after each vaccination | safety analysis | Within 30 days (Day 0-30) after any vaccination |
| Safety3: Serious adverse events occurred throughout the study | safety analysis. To evaluate number of SAEs compared with the control vaccine. | Up to 78 month |
| Safety4: Pregnancy and pregnancy outcome | safety analysis. To evaluate number of births and terminations compared with the control vaccine. | Up to 78 month |
| Safety5: New-onset acute and chronic diseases (especially autoimmune diseases) | safety analysis.To evaluate number of new-onset acute and chronic diseases (especially new-onset autoimmune diseases) throughout the study. | Up to 78 month |
| Incidence of CIN1 + and/or VIN1 + and/or VaIN1 + lesions related to HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 or 68 (Combined analysis of the high risk types) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Incidence of Persistent infection of HPV35, 39,51,56,59 and 68 (total infection and over 6 months and over 12 months) (Independent analysis of each type) | To evaluate the efficacy of the nine-valent vaccine against this outcome compared with the control vaccine | Cumulative incidence of this endpoint events in 78 months after the first dose |
| Chengdu |
| Sichuan |
| 610041 |
| China |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
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