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Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.
This study is a multi-centre, randomized, blinded, placebo controlled study. The study vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the placebo is aluminium phosphate diluent.
After informed and received the consent of participants/guardians, 1200 healthy females aged 9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1, vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo diluent.
Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6 months). After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. For every participants, blood samples will be collected before the first inoculation (month 0), one month after the final inoculation (month 7), 6 months after the final inoculation (month 12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and immunogenicity analysis. For participants in 9-14 age group who received the vaccine, neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune persistency. Meanwhile, some participants will be chosen to study the deviation of gene expression after the vaccination and the association of that with the neutralizing antibody level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV vaccine 1 | Experimental | 300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
|
| Placebo 1 | Placebo Comparator | 300 women between 9-17 yeas of age, receiving 0,2,6 month-schedule Placebo. |
|
| HPV vaccine 2 | Experimental | 120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
|
| HPV vaccine 3 | Experimental | 180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule experimental HPV vaccines |
|
| Placebo 2 | Placebo Comparator | 120 women between 18-26 yeas of age, receiving 0,2,6 month-schedule Placebo. |
|
| Placebo 3 | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV vaccine | Biological | Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| The neutralizing antibody responses of HPV 16/18 after vaccination by measuring Geometric Mean Titer (GMT). | 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions | 7 days after each vaccine dose | |
| Occurrence, intensity and relationship to vaccination of any solicited local or systemic reactions | 6 months after finish vaccinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rong-cheng Li, MD | Guangxi Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GuangXi Center for Diseases Control and Prevention | Nanning | Guangxi | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D053918 | Papillomavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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180 women between 27-45 yeas of age, receiving 0,2,6 month-schedule Placebo.
|
| Placebo | Biological | Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule |
|
| The durability of neutralizing antibody responses of HPV 16/18 after vaccination. | 48 months after finish vaccinations |
| 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 |