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| ID | Type | Description | Link |
|---|---|---|---|
| V503-071 | Other Identifier | Merck |
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This study aims to demonstrate that a 2-dose regimen of the 9-Valent Human Papillomavirus (9vHPV) vaccine (GARDASIL™9, V503) induces non-inferior competitive Luminex immunoassay (cLIA) geometric mean titers (GMTs) to each of the 9vHPV vaccine types in Chinese girls 9 through 14 years of age compared to a 3-dose regimen in Chinese women 20 through 26 years of age. The primary hypothesis is that a 2-dose regimen has a non-inferiority margin of 0.67 in the GMT ratio (girls vs. women) for each HPV type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9 to 14 Years Old: Day 1 and Month 6 | Experimental | Chinese females 9 to 14 years old will receive a 0.5 mL intramuscular (IM) injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 6 |
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| 9 to 14 Years Old: Day 1 and Month 12 | Experimental | Chinese females 9 to 14 years old will receive a 0.5 mL iIM injection of 9-valent HPV (9vHPV) vaccine on Day 1 and Month 12 |
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| 20 to 26 Years Old: Day 1, Month 2 and Month 6 | Experimental | Chinese females 20 to 26 years old will receive a 0.5 mL IM injection of 9-valent HPV (9vHPV) vaccine on Day 1, Month 2 and Month 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9vHPV vaccine | Biological | A 9-valent HPV vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, and 58) will be administered as a 0.5 mL IM injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Stage I: Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) to 9 vaccine types of 9vHPV vaccine | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine. The GMT for each HPV type will be reported in mMU/mL. | One month after last dose (Up to Month 13) |
| Stage II: cLIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
| Stage II: cLIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | cLIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized. | Up to Month 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Stage I: cLIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | cLIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
| Stage I: Immunoglobulin G Luminex immunoassay (IgG LIA) GMTs to 9 vaccine types of 9vHPV vaccine at one month post last dose |
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The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangshan Center for Disease Control and Prevention ( Site 0001) | Quzhou | Zhejiang | 324100 | China | ||
| Yuhuan Center for Disease Control and Prevention ( Site 0002) |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine at one month post last dose. The GMT for each HPV type will be reported in mMU/mL. |
| One month after last dose (Up to Month 13) |
| Stage I: IgG LIA seroconversion percentages to 9 vaccine types of 9vHPV vaccine | IgG LIA seroconversion to each of 9 vaccine types of 9vHPV vaccine. The percentage of participants who are seropositive for each HPV type will be summarized. | One month after last dose (Up to Month 13) |
| Stage I: Percentage of participants experiencing solicited injection-site adverse events (AEs) | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Solicited injection-site AEs such as erythema, swelling, pain, and induration at the injection site will be recorded. | Day 1 through Day 8 following any study vaccination |
| Stage I: Percentage of participants experiencing solicited systemic AEs | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Systemic AEs are those not categorized as injection-site AEs. | Day 1 through Day 8 following any study vaccination |
| Stage I: Percentage of participants experiencing serious AEs (SAEs) Up to Month 13 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Up to Month 13 |
| Stage II: Percentage of participants experiencing SAEs Up to Month 84 | A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. | Month 18 up to Month 84 |
| Stage II: IgG LIA GMTs to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA GMT to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The GMT for each HPV type will be reported in mMU/mL. | Up to Month 84 |
| Stage II: IgG LIA seropositivity percentages to 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age | IgG LIA seropositivity to each of 9 vaccine types of 9vHPV vaccine in girls 9 through 14 years of age. The percentage of participants who are seropositive for each HPV type will be summarized | Up to Month 84 |
| Taizhou |
| Zhejiang |
| 317600 |
| China |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |