This phase IIIb trial compares a single dose of the Cervarix vaccine in girls to 3 doses of the Gardasil vaccine in young women for the prevention of human papillomavirus (HPV) infection. Cervarix is a vaccine used to prevent cervical cancer caused by HPV types 16 and 18. Gardasil is vaccine used to prevent cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11. Giving only one dose of the Cervarix vaccine in girls may work the same as 3 doses of the Gardasil vaccine in young women in preventing HPV infection and ultimately, cervical and other HPV-related cancers. Currently, many women around the world cannot get HPV vaccines because they are too expensive. If this trial can show one dose given to young girls is enough to prevent cancer, more girls might be able to get the vaccine.
PRIMARY OBJECTIVE: I. To demonstrate that the immunogenicity (as determined by enzyme-linked immunosorbent assay \[ELISA\]) of a single dose of recombinant human papillomavirus bivalent vaccine (Cervarix) in 9-14 year old girls is non-inferior to the immunogenicity of three doses of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil), administered at 0, 2, and 6 months, in 18-25 year old women 36 months after initial vaccination, with an interim analysis at 24 months after initial vaccination. SECONDARY OBJECTIVES: I. To compare the distribution of HPV -16 and HPV-18 antibodies levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. II. To compare rates of seroconversion based on HPV-16 and HPV-18 antibody levels, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-14 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women. III. To compare geometric mean titers (GMTs), distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination, following a single dose of Cervarix in 9-11 year old girls and three doses of Gardasil, administered at 0, 2, and 6 months, in 18-25 year old women; to perform a similar comparison restricting to 12-14 year old girls. IV. To compare GMTs, distributions, and seroconversion rates for HPV-16 and HPV-18 antibodies, assessed at 1-month after vaccination and 1-year after vaccination, following a single dose of Cervarix in 9-10 year old girls and a single dose of Cervarix in 11-14 year old girls. V. To evaluate whether baseline variables (e.g. geographic district, initial antibody levels, date of vaccination) are associated with GMTs, distributions, and seroconversion rates for HPV16 and HPV-18 antibodies, assessed at 24 and 36 months after initial vaccination. OUTLINE: Participants are assigned to 1 of 2 groups. GROUP I: Participants 9-14 years old receive Cervarix intramuscularly (IM) at baseline. GROUP II: Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. After completion of trial vaccine dose(s), participants are followed up at 1, 12, 24, and 36 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,240
Given IM
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste Province, Costa Rica
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.
Time frame: 36 months following initial HPV vaccination
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.
Time frame: 36 months following initial vaccination
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.
Time frame: 36 months following initial vaccination
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.
Time frame: 36 months following initial vaccination
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.
Time frame: 24 months following initial HPV vaccination
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
Time frame: 24 months following initial vaccination
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.
Time frame: 24 months following initial vaccination
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.
Time frame: 24 months following initial vaccination
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.
Time frame: 36 months
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.
Time frame: 36 month
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 36 months following initial vaccination
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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.
Time frame: 36 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 24 month
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 month
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 12 months
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 12 month
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.
Time frame: 12 months
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.
Time frame: 1 year
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.
Time frame: 36 months
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 months
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 months
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.
Time frame: 24 month
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.
Time frame: 24 month
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.
Time frame: 24 months
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.
Time frame: 24 month
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.
Time frame: 24 month
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
Time frame: 36 month
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
Time frame: 36 month
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
Time frame: 36 month
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
Time frame: 36 month
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
Time frame: 36 month
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
Time frame: 36 month
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
Time frame: 24 month
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
Time frame: 24 month
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
Time frame: 24 month
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
Time frame: 24 month
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
Time frame: 24 month
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
Time frame: 24 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 36 month
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.
Time frame: 24 month
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.
Time frame: 24 month
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.
Time frame: 24 month
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.
Time frame: 24 month
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.
Time frame: 24 month
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.
Time frame: 24 month