| Primary | Base Stage: Geometric Mean Titers for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18: Competitive Luminex Immunoassay (cLIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). | Per protocol, the analysis population included the participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 7 (1 month postdose 3) | | | | ID | Title | Description |
|---|
| OG000 | Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| | | Title | Denominators | Categories |
|---|
| Anti-HPV 6 | - ParticipantsOG000343
- ParticipantsOG001315
| | Title | Measurements |
|---|
| - OG000975.2(905.6 to 1050.2)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | <0.0001 | | GMT Ratio | 1.42 | | | 2-Sided | 95 | 1.28 | 1.58 | | | GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr) | | Non-Inferiority | The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type. | | |
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| Primary | Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 12 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 24 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 36 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 48 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-Human Papillomavirus (HPV) Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA | Serum antibody titers (Geometric mean titers) for HPV virus-like particles (VLPs) Types 6, 11, 16, and 18 were measured. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 60 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by cLIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 12 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by cLIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 24 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 36 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by cLIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 48 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by cLIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using cLIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 60 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 12 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 12 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 24 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 24 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 36 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. Antibody titers were expressed as (mMU/mL). | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 36 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 48 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 48 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: GMTs for Serum Anti-HPV Types 6, 11, 16, and 18 at Month 60 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA) | Serum antibody titers (Geometric mean titers) for HPV Types 6, 11, 16, and 18 were measured. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 60 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 12 Assessed by IgG LIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 12 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 24 Assessed by IgG LIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 24 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by IgG LIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 36 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 48 Assessed by IgG LIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Geometric Mean | 95% Confidence Interval | Percentage of Participants | | Month 48 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Primary | Extension Stage: Percentage of Participants With Seropositivity to HPV Types 6, 11, 16, and 18 at Month 60 Assessed by IgG LIA | The percentage of participants who are seropositive to each of HPV Types 6, 11, 16, and 18 were assessed. Antibodies were measured using IgG LIA. | Per protocol, the analysis population included participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Month 60 post-vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Year | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
| |
| Secondary | Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: cLIA | Seroconversion is defined as changing serostatus from seronegative at Day 1 to seropositive at 1 month post dose 3. Antibodies were measured using a Competitive Luminex Immunoassay (cLIA). Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). | Per protocol, the analysis population included the participants with immune response to each of the 4 HPV types (6, 11, 16, and 18), who received 3 vaccinations and met following criteria: received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), had a Day 1 through Month 7 serum sample collected within an acceptable day range, and had no protocol violation that potentially interfered with the evaluation of immune responses to the qHPV vaccine. | Posted | | Number | | Percentage of Participants | | Month 7 (1 month postdose 3) | | | | ID | Title | Description |
|---|
| OG000 | Base Study: Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
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| Secondary | Base Stage: Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: IgG LIA | Antibodies to HPV Types 6, 11, 16, and 18 were measured using an IgG LIA. Antibody titers were expressed as milli Merck Units/milliliter (mMU/mL). | All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage. | Posted | | Geometric Mean | 95% Confidence Interval | mMU/mL | | Month 7 (1 month postdose 3) | | | | ID | Title | Description |
|---|
| OG000 | Base Study: Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| |
| Secondary | Base Stage: Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: IgG LIA | The percentage of participants who seroconverted to each of HPV Types 6, 11, 16, and 18 was assessed. Antibodies were measured using IgG LIA. | All participants who received the correct dose of all 3 study vaccinations within visit window; was seronegative at Day 1 for the human papilloma virus (HPV) type being analyzed; provided Month 7 serum sample within visit window; and did not meet any exclusion criteria at any time during base stage. | Posted | | Number | | Percentage of Participants | | Month 7 (1 month postdose 3) | | | | ID | Title | Description |
|---|
| OG000 | Base Study: Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| |
| Secondary | Base Stage: Percentage of Participants Who Experienced a Solicited Injection-site Adverse Event (AE) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site redness, swelling, induration, pain, and pruritus. | The analysis population concisted of participants who recieved at least one dose of study vaccination. | Posted | | Number | | Percentage of Participants | | Up to 15 days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Base Study: Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| |
| Secondary | Base Stage: Percentage of Participants Participants Who Experienced a Solicited Systemic AE | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included hypersensitivity, headache, fatigue, vomiting, nausea, diarrhea, myalgia, pyrexia, and cough. | The analysis population concisted of participants who recieved at least one dose of study vaccination. | Posted | | Number | | Percentage of Participants | | Up to 15 days after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
| |
| Secondary | Base Stage: Percentage of Participants Who Experienced a Serious Adverse Event (SAE) | An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. | The analysis population concisted of participants who recieved at least one dose of study vaccination. | Posted | | Number | | Percentage of Participants | | Up to Month 7 (1 month postdose 3) | | | | ID | Title | Description |
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| OG000 | Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
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| Secondary | Base Stage: Percentage of Participants Who Experienced an AE | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment | The analysis population concisted of participants who recieved at least one dose of study vaccination. | Posted | | Number | | Percentage of Participants | | Up to 31 days after any vaccination | | | | ID | Title | Description |
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| OG000 | Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
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| Secondary | Base Stage: Maximum Axillary Temperature: Merck Sharp & Dohme (MSD) Criteria | In the global studies, fever is defined as an oral temperature of ≥37.8°C or 100.0°F, which is equivalent to axillary temperature of ≥37.2°C, while the definition of fever is axillary temperature of ≥37.1°C in Chinese criteria. To be compliant to Chinese criteria, axillary temperatures of ≥37.1°C was considered as a fever in this study. Body temperature readings assessed orally were converted to the axillary equivalent. The percentage of participants with a maximum axillary or converted axillary temperature was summarized by temperature range. | The analysis population concisted of participants who recieved at least one dose of study vaccination. | Posted | | Number | | Percentage of Participants | | Up to 5 days after any vaccination | | | | ID | Title | Description |
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| OG000 | Chinese Girls Aged 9 to 19 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 | | OG001 | Base Study: Chinese Young Women Aged 20 to 26 Years | Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
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| Secondary | Extension Stage: Percentage of Participants Who Experienced an SAE | The percentage of participants with an SAE will be assessed. An SAE is an AE that results in death, is life threatening, requires hospitalization or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, according to medical or scientific judgment, may jeopardize the participant or requires medical or surgical intervention to prevent one of the other outcomes listed in the above definition. | The analysis population consisted of all participants who received at least 1 dose of study vaccination and had clinical follow-up for safety. | Posted | | Number | | Percentage of Participants | | Month 7 up to Month 60 | | | | ID | Title | Description |
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| OG000 | Extension Study: Chinese Girls Aged 9 to 19 Years | In base study, participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 and followed up to Month 7. In the extension studies after Month 7, the participants were followed up for safety and immunogenicity up to Month 60 (EXT) |
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