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The purpose of this study is to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (Escherichia coli) (HPV)and Measles Mumps and Rubella Combined Vaccine, Live(MMR)
Main subjects:
To evaluate the immunogenicity of HPV vaccine and MMR vaccine at the same time but at different sites as not inferior to vaccination of HPV vaccine or MMR vaccine alone.
Secondary subjects:
To evaluate the safety of simultaneous administration of HPV vaccine and MMR vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Participants in this arm will be simultaneously administrated with one dose of HPV 16/18 bivalent vaccine and one dose of MMR vaccine. six month later, they are going to receive a second dose of HPV 16/18 bivalent vaccine. |
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| Group B | Active Comparator | Participants in this arm will be receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months) first. After finished HPV vaccination, they are going to receive MMR vaccine at the 7th month. |
|
| Group C | Active Comparator | Participants in this arm will be receieve MMR vaccine first. One month later, they are going to receieve HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV+MMR(0d),HPV(6m) | Biological | Simultaneously administrated with MMR vaccine and HPV 16/18 bivalent vaccine at first. And six months later, administrated with the second dose of HPV 16/18 bivalent vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the seroconversion rates and geometric mean concentrations of anti-HPV 16 and 18 at Months 7 (type specific neutralizing antibody) | Detect the level of anti-HPV 16 and 18 specific neutralizing antibodies at one month after the second dose to determine whether group A is non-inferior to group B | Specific neutralizing antibodies at 7 months after first dose |
| Evaluate seroconversion rates and geometric mean concentrations of anti-measles at the 1st month after MMR vaccination | Detect the level of anti-measles specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C | 1 months after vaccination |
| Evaluate seroconversion rates and geometric mean concentrations of anti-rubella at the 1st month after MMR vaccination | Detect the level of anti-rubella specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C | 1 months after vaccination |
| Evaluate seroconversion rates and geometric mean concentrations of anti-mumps at the 1st month after MMR vaccination | Detect the level of anti-mumps specific neutralizing antibodies at one month after MMR vaccination to determine whether group A is non-inferior to group C | 1 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Local and systematic adverse events/reactions occurred within 7 days after each vaccination | Adverse reactions associated with vaccine will be observed in subjects after vaccination. To evaluate number of adverse events/reactions compared with non-simultane vaccination group. | During the 7-day (Day 0-6) period following each vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuecheng Center for Disease Control and Prevention | Shaoxing | Zhejiang | 3306 | China | ||
| Wuyi Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41276263 | Derived | Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2. |
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| HPV(0d),HPV(6m),MMR(7m) | Biological | Administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (0,6 months).And at the 7th month , administrated with MMR vaccine. |
|
| MMR(0d),HPV(1m),HPV(7m) | Biological | Administrated with MMR vaccine at first day. And administrated with HPV 16/18 bivalent vaccine according to 2-dose schedule (1,7 months). |
|
| Adverse events/reactions occurred within 30 days after each vaccination |
To evaluate number of adverse events/reactions compared with non-simultane vaccination group. |
| Within 30 days (Day 0-30) after any vaccination |
| Serious adverse events occurred throughout the study | safety analysis. To evaluate number of SAEs compared with the non-simultane vaccination group. | Up to 7 months |
| Wuyi |
| Zhejiang |
| 3307 |
| China |
| ID | Term |
|---|---|
| D008457 | Measles |
| D012409 | Rubella |
| D009107 | Mumps |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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