| Primary | Number Seropositive for HPV16 at 36 Months | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis. | The primary cohort for the final analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 months following initial HPV vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Primary | Immunogenicity for HPV16 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2 and 6 Months, in 18-25 Year Old Women, 36 Months After Initial Vaccination | Will measure HPV-16 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months. | The primary cohort for the final analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Number Seropositive for HPV18 at 36 Months | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis. | The primary cohort for the final analysis of HPV18 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Immunogenicity for HPV18 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 36 Months After Initial Vaccination | Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the GMT ratios for HPV-16 and HPV-18 at 24 months and the two-sided 96% confidence intervals of the GMT ratios for HPV-16 and HPV-18 at 36 months. | Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 96% confidence intervals of the Geometric Mean Concentration (GMC) ratio for HPV-18 at 36 months. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Number Seropositive for HPV16 at 24 Months | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis. | The primary cohort for the interim analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 months following initial HPV vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Immunogenicity for HPV16 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 24 Months After Initial Vaccination | Will measure HPV-16 specific serum antibody using the HPV type-specific enzyme-linked immunoassay (ELISA) on serum. Will estimate the two-sided 99% confidence interval of the geometric mean concentration (GMC) ratio for HPV-16 at 24 months | The primary cohort for the final analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Number Seropositive for HPV18 at 24 Months | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis. | The primary cohort for the interim analysis of HPV18 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Primary | Immunogenicity for HPV18 of One Dose of Bivalent HPV Vaccine (Cervarix) in 9-14 Year Old Girls Compared to Three Doses of Quadrivalent HPV Vaccine (Gardasil), Administered at 0,2, and 6 Months, in 18-25 Year Old Women, 24 Months After Initial Vaccination | Will measure HPV-18 specific serum antibody using the HPV type-specific ELISA on serum. Will estimate the two-sided 99% confidence interval of the Geometric Mean Concentration (GMC) ratio for HPV-18 at 24 months. | The primary cohort for the interim analysis of HPV18 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months | To compare proportions with seroconversion based on HPV16 antibody levels, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | | Posted | | Count of Participants | | Participants | | 36 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months | To compare proportions with seroconversion based on HPV18 antibody levels, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months | To compare proportions with seroconversion based on HPV16 antibody levels, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months | To compare proportions with seroconversion based on HPV18 antibody levels, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Distribution of HPV16 antibodies levels assessed at 36 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV16 antibodies levels assessed at 36 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles. | The primary cohort for the final analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Median | Full Range | International units (IU/mL) | | 36 months following initial vaccination | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Distribution of HPV18 antibodies levels assessed at 36 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV18 antibodies levels assessed at 36 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown in medians and ranges by deciles. | The primary cohort for the final analysis of HPV18 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Median | Full Range | International units (IU/mL) | | 36 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Distribution of HPV16 antibodies levels assessed at 24 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV16 antibodies levels assessed at 24 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles. | The primary cohort for the interim analysis of HPV16 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Median | Full Range | International units (IU/mL) | | 24 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Distribution of HPV18 antibodies levels assessed at 24 months following a single dose of Cervarix in 9-14 year old girls compared to distribution of HPV18 antibodies levels assessed at 24 months following three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. Shown as medians and ranges by deciles. | The primary cohort for the interim analysis of HPV18 includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Median | Full Range | International units (IU/mL) | | 24 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®) | Participants 9-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis. | The primary cohort for the analysis of HPV16 among girls 11-14 at and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
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| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | To compare GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | The primary cohort for the analysis of HPV16 among girls 11-14 at and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®), Excluding 9-10 Year Old Girls | Participants 11-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. |
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| Secondary | Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | To compare seroconversion proportions for HPV16 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. | The primary cohort for the analysis of HPV16 among girls 11-14 at and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
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| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis. | The primary cohort for the analysis of HPV18 among girls 11-14 at and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
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| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | To compare GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | The primary cohort for the analysis of HPV18 among girls 11-14 at and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®), Excluding 9-10 Year Old Girls | Participants 11-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | To compare seroconversion proportions for HPV18 antibodies, assessed at 36 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | The primary cohort for the analysis of HPV16 among girls 11-14 years old and women at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®), Excluding 9-10 Year Old Girls | Participants 11-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA concentration is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis. | The primary cohort for the analysis of HPV16 among girls 11-14 and women at 24 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
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| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | To compare GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | The primary cohort for the analysis of HPV16 among girls 11-14 and women at 24 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 months | | | | ID | Title | Description |
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| OG000 | Girls (1D Cervarix®), Excluding 9-10 Year Old Girls | Participants 11-14 years old receive Cervarix IM at baseline. | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | To compare seroconversion proportions for HPV16 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | The primary cohort for the interim analysis of HPV16 includes 11-14-year-old girls and women who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
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| OG000 | 11-14 Year Old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA concentration is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis. | The primary cohort for the interim analysis of HPV18 includes 11-14-year-old girls and women who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
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| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | To compare GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | To compare seroconversion proportions for HPV18 antibodies, assessed at 24 months after initial vaccination, following a single dose of Cervarix in 11-14-year-old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25-year-old women. | The cohort for this analysis at 24 months includes girls 11-14 and women who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
| |
| Secondary | Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 1-month sample does not generate a valid HPV16 result will be excluded only from the 1-month HPV16 analysis. | The cohort for the 1 month analysis of HPV16 includes 9-14 year old girls who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 1-month mark, and reported no additional HPV vaccinations outside the study before the 1-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Years Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | To compare GMCs for HPV16 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | The cohort for the 1 month analysis of HPV16 includes 9-14 year old girls who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 1-month mark, and reported no additional HPV vaccinations outside the study before the 1-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10-year-old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | To compare seroconversion proportions for HPV16 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls. | Since both groups had a 100% seroconversion proportion, p-value could not be calculated. | Posted | | Count of Participants | | Participants | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Year Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 1-month sample does not generate a valid HPV18 result will be excluded only from the 1-month HPV18 analysis. | The primary cohort for the 1-month analysis of HPV18 includes girls who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 1-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Years Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | To compare seroconversion proportions for HPV18 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | The primary cohort for the analysis of HPV18 among girls 9-14 at 1 month includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 1-month mark, and reported no additional HPV vaccinations outside the study before the 1-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Year Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14 Year Old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | To compare seroconversion proportions for HPV18 antibodies, assessed at 1 month after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | Since both groups had a 100% seroconversion proportion, p-value could not be calculated. | Posted | | Count of Participants | | Participants | | 1 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10-year-old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 12-month sample does not generate a valid HPV16 result will be excluded only from the 12-month HPV16 analysis. | The cohort for the 12-month analysis of HPV16 includes girls 9-14 years old who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Years Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | To compare GMCs for HPV16 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | The cohort for the analysis of HPV16 at 12 months includes girls 9-14 years old who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 9-10-year-old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | To compare seroconversion proportions for HPV16 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls. | The cohort for the analysis of HPV16 at 12 months includes girls 9-14 years old who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Year Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 12-month sample does not generate a valid HPV18 result will be excluded only from the 12-month HPV18 analysis. | The primary cohort for the 12-month analysis of HPV18 includes 9-14 year old girls who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection. | Posted | | Count of Participants | | Participants | | 12 month | | | | ID | Title | Description |
|---|
| OG000 | 9-10 Years Old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | To compare GMCs for HPV18 antibodies, assessed at 12 months after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls. in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | The cohort for the analysis of HPV18 at 12 months includes girls 9-14 years old who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 12 months | | | | ID | Title | Description |
|---|
| OG000 | 9-10-year-old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | To compare seroconversion proportions for HPV18 antibodies, assessed at 1 year after vaccination, following a single dose of Cervarix in 9-10-year-old girls and following a single dose of Cervarix in 11-14-year-old girls, in order to compare girls who were in and not in the age range for routine HPV vaccination in Costa Rica. | The cohort for the analysis of HPV18 at 12 months includes girls 9-14 years old who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 12-month mark, and reported no additional HPV vaccinations outside the study before the 12-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
|---|
| OG000 | 9-10-year-old Girls (1D Cervarix®) | Participants 9-10 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 11-14-year-old Girls (1D Cervarix®) | Participants 11-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV16 result will be excluded only from the 36-month HPV16 analysis. | The primary cohort for the analysis of HPV16 by enrollment age grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11 | Posted | | Count of Participants | | Participants | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) |
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| Secondary | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination. | The cohort for the analysis of HPV16 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination. | | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG003 | 22-25 Year Old Women (3D Gardasil-4®) | Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 36-month sample does not generate a valid HPV18 result will be excluded only from the 36-month HPV18 analysis. | The primary cohort for the analysis of HPV18 by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination. | The cohort for the analysis of HPV18 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Girls (1D Cervarix) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14 Girls (1D Cervarix) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Women (3D Gardasil) | Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination. | The cohort for the analysis of HPV18 at 36 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14 Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | Will measure HPV16 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV16 is seropositive if the ELISA titer is greater than 1.41 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV16 result will be excluded only from the 24-month HPV16 analysis. | The cohort for the analysis of HPV16 at 24 months by enrollment age grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11 | Posted | | Count of Participants | | Participants | | 36 months | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) |
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| Secondary | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination. | The cohort for the analysis of HPV16 at 24 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
|
| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination. | The cohort for the analysis of HPV16 at 24 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
|
| Secondary | Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | Will measure HPV18 specific serum antibody using the HPV type-specific ELISA on serum. For computing proportions seropositive and proportions seroconverting, HPV18 is seropositive if the ELISA titer is greater than 1.05 IU/mL. Participants whose analysis of the 24-month sample does not generate a valid HPV18 result will be excluded only from the 24-month HPV18 analysis. | The primary cohort for the analysis of HPV18 at 24 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 months | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) |
|
| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination. | The cohort for the analysis of HPV18 at 24 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
|
| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination. | The cohort for the analysis of HPV18 at 24 months by enrollment age group includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | 9-11 Year Old Girls (1D Cervarix®) | Participants 9-11 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | 12-14-year-old Girls (1D Cervarix®) | Participants 12-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG002 | 18-21 Year Old Women (3D Gardasil-4®) | Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM |
|
| Secondary | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV16 at 36 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV16 at 36 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The primary cohort for the analysis of HPV16 at 36 months includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 36 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 36 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 36 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV16 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV16 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV16 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month | The cohort for the analysis of HPV18 at 24 months by enrollment month grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Girls (1D Cervarix) Enrolled April-May | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Women (3D Gardasil) Enrolled April-May | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Girls (1D Cervarix) Enrolled June-August | |
|
| Secondary | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 36 months by enrollment district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
|
| Secondary | Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 36 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 36 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Median | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
|
| Secondary | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 36 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
|
| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 36 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 36 months by enrollment district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 36-month mark, and reported no additional HPV vaccinations outside the study before the 36-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 36 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
|
| Secondary | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
|
| Secondary | Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
|
| Secondary | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV16 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV16, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
|---|
| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
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| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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| Secondary | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Geometric Mean | 95% Confidence Interval | International units (IU/mL) | | 24 month | | | | ID | Title | Description |
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| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | |
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| Secondary | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. | The cohort for the analysis of HPV18 at 24 months by district grouping includes participants who received the appropriate number of vaccine doses within the specified windows, were initially seronegative for HPV18, underwent blood collection at the 24-month mark, and reported no additional HPV vaccinations outside the study before the 24-month blood collection, as confirmed by self-report or serologic testing for HPV6/HPV11. | Posted | | Count of Participants | | Participants | | 24 month | | | | ID | Title | Description |
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| OG000 | Coastal Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM | | OG001 | Coastal Women (3D Gardasil) | Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM | | OG002 | Mountainous Girls (1D Cervarix) | Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM |
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