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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 is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9-17y (0,6m) | Experimental | Subjects who aged 9-17 years old would receive 2 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) . |
|
| 9-17y (0,1,6m) | Experimental | Subjects who aged 9-17 years old would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) . |
|
| 18-26y (0,1,6m) | Experimental | Subjects who aged 18-26 years old would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) | Biological | Three doses administered intramuscularly at 0, 1 and 6 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity1: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-26 years old receiving 3 doses of the nonavalent vaccine | To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-17 years receiving 3 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine. | 7 months after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity2: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at Months 7 in the population aged 9-14 years old receiving 2 doses of the nonavalent vaccine | To determine whether the immune responses (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at month 7 (one month after the final dose) in the population aged 9-14 years receiving 2 doses of the nonavalent vaccine are noninferior to those in women aged 18-26 years receiving 3 doses of vaccine. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, master | Xiamen University | Study Chair |
| Xue-cheng Liu, master | Sichuan Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial Centre for Disease Control and Prevention | Chengdu | Sichuan | 610041 | China |
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| 2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli) | Biological | Two doses administered intramuscularly at 0 and 6 month. |
|
| 7 months after the first dose |
| Immunogenicity3: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific antibody levels at months 18 and 30 in the population aged 9-14 and 15-17 years old receiving 2 doses or 3 doses of the nonavalent vaccine | To determine the immune persistence (antibodies to HPV-6, 11, 16, 18, 31, 33, 45, 52, and 58) at months 18 and 30 in the population receiving 2 doses or 3 doses of the nonavalent vaccine | 30 months after the first dose |
| Safety1: Local and systematic adverse events/reactions occurred within 7 days after each vaccination. | Local and systematic adverse events/reactions occurred within 7 days after each vaccination. | During the 7-day period following each vaccination |
| Safety2: Adverse events/reactions occurred within 30 days after each vaccination. | Adverse events/reactions occurred within 30 days after each vaccination. | Within 30 days (Day 0-30) after any vaccination |
| Safety3: Severe adverse events occurred throughout the study. | Severe adverse events occurred throughout the study. To evaluate number of SAEs between the different arms. | Up to 8 month |
| Safety4: Pregnancy and pregnancy outcome. | Pregnancy and pregnancy outcome. To evaluate number of births and terminations between the different arms. | Up to 8 month |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| 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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