Human Papillomavirus-Related Cervical Carcinoma
Conditions
Keywords
HPV vaccine, Single dose HPV vaccination
Brief summary
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.
Detailed description
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.
Interventions
Given IM
Sponsors
Cancer Research UK
Bill and Melinda Gates Foundation
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between: * 9 and 14 years inclusive for Cervarix group * 18 and 25 years inclusive for Gardasil group * Living in the study area without plans to move outside the country in the next six months * Able to communicate with study personnel * Able and willing to provide a blood sample * Willing to permit export of blood samples to the United States * Willing to participate in the study and: * If Cervarix group and less than 12 years old, receive study information and be supported in study participation by at least one of parent (or guardian), who is willing to sign the informed consent document * If Cervarix group and 12 years old or older, sign the informed assent and be supported in study participation by at least one parent (or guardian), who is willing to sign the informed consent document * If Gardasil group, sign the informed consent * In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion)
Exclusion criteria
* They have a diagnosis of an autoimmune, degenerative, or neurological disease without treatment or adequate control; a progressive or severe neurological disease; a genetic immunodeficiency; or any other serious chronic disease without treatment and / or adequate control that, according to the principal investigator or designee, for which vaccination is contraindicated (NOTE: Potential participants with these conditions can be included after consultation with the external medical advisor of the study or with an appropriate specialist) * They are allergic to one of the vaccine components, including yeast (if Gardasil group) * They have received immunoglobulins within 90 days preceding enrollment/vaccination visit * They are unwilling to provide a blood sample * Unwilling to permit export of blood samples to the United States * They have a positive urine pregnancy test result * They are pregnant * They are planning to become pregnant * The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation * They have been vaccinated against HPV * The participant or her parent/legal guardian, as applicable, does not have an identification document
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Seropositive for HPV16 at 36 Months | 36 months following initial HPV vaccination | 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. |
| 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 | 36 months following 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. |
| Number Seropositive for HPV18 at 36 Months | 36 months following initial vaccination | 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. |
| 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 | 36 months following 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. |
| Number Seropositive for HPV16 at 24 Months | 24 months following initial HPV vaccination | 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. |
| 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 | 24 months following 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 |
| Number Seropositive for HPV18 at 24 Months | 24 months following initial vaccination | 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. |
| 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 | 24 months following 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds | 36 month | 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. |
| Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 36 month | 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. |
| Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 36 month | 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. |
| Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds | 36 month | 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 36 month | 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. |
| Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 36 month | 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. |
| Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds | 24 month | 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. |
| Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 24 months | 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. |
| Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 24 months | 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. |
| Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds | 24 month | 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 24 months | 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. |
| Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 24 months | 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. |
| Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 1 month | 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. |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | 36 month | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination. |
| Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 1 month | 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. |
| Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 1 month | 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. |
| Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 1 month | 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 1 month | 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. |
| Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 1 month | 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. |
| Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 12 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 12-month sample does not generate a valid HPV16 result will be excluded only from the 12-month HPV16 analysis. |
| Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 1 year | 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. |
| Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 1 year | 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. |
| Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 12 month | 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 12 months | 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. |
| Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 1 year | 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. |
| Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | 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 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. |
| Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | 36 month | To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination. |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | 36 month | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination. |
| Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | 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 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | 36 month | To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination. |
| Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | 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 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. |
| Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | 24 month | To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination. |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | 24 month | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination. |
| Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | 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. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | 24 month | To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination. |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | 24 month | To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination. |
| Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month |
| Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | 36 month | HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | 36 month | HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | 24 month | HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months | 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. |
| Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | 24 month | HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region. |
| Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months | 36 month | 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. |
| Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months | 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. |
| Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months | 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. |
| Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | 36 months following initial vaccination | 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. |
| Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | 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. |
| Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | 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. |
| Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | 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. |
Countries
Costa Rica
Participant flow
Recruitment details
Multiple methods were used to reach potential participants within the PRIMAVERA catchment area, including publicizing through attending community events, distributing outreach materials in commercial and residential areas, making announcements, and going door-to-door. As needed for potential participants registered away from their residence, in-person verification of potential participants' addresses was conducted to ensure they resided in the catchment area.
Pre-assignment details
Of 1655 registered individuals (773 girls 9-14 years old and 882 women 18-25 years old), 113 were ineligible (44 girls and 69 women), 184 refused (91 girls and 93 women), and 118 were excluded due to termination of the field effort (18 girls and 100 women). Individuals were ineligible if they could not provide blood, fell outside the eligible age range, resided outside the catchment area, had previously received an HPV vaccination, or had a medical condition that warranted exclusion.
Participants by arm
| Arm | Count |
|---|---|
| Girls (1D Cervarix®) Participants 9-14 years old receive Cervarix IM at baseline. | 620 |
| 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. | 620 |
| Total | 1,240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| ATP Cohort for HPV16 at 36 Months | HPV16 seropositive at baseline | 36 | 179 |
| ATP Cohort for HPV18 at 36 Months | HPV18 seropositive at baseline | 52 | 172 |
| Enrolled and Received 1st Vaccination | Adverse Event | 0 | 1 |
| Enrolled and Received 1st Vaccination | Death | 1 | 1 |
| Enrolled and Received 1st Vaccination | HPV6/11 positive | 10 | 0 |
| Enrolled and Received 1st Vaccination | No Show | 0 | 1 |
| Enrolled and Received 1st Vaccination | Not fully vaccinated during ATP windows | 0 | 49 |
| Enrolled and Received 1st Vaccination | Out of Country | 1 | 3 |
| Enrolled and Received 1st Vaccination | Received HPV vaccination outside study (self-report) | 25 | 0 |
| Enrolled and Received 1st Vaccination | Unable to appoint | 3 | 12 |
| Enrolled and Received 1st Vaccination | Withdrawal by Subject | 5 | 8 |
Baseline characteristics
| Characteristic | Girls (1D Cervarix®) | Total | Women (3D Gardasil-4®) |
|---|---|---|---|
| Age, Customized Age 10 years | 44 Participants | 44 Participants | 0 Participants |
| Age, Customized Age 11 years | 137 Participants | 137 Participants | 0 Participants |
| Age, Customized Age 12 years | 126 Participants | 126 Participants | 0 Participants |
| Age, Customized Age 13 years | 126 Participants | 126 Participants | 0 Participants |
| Age, Customized Age 14 years | 115 Participants | 115 Participants | 0 Participants |
| Age, Customized Age 18 years | 0 Participants | 75 Participants | 75 Participants |
| Age, Customized Age 19 years | 0 Participants | 98 Participants | 98 Participants |
| Age, Customized Age 20 years | 0 Participants | 82 Participants | 82 Participants |
| Age, Customized Age 21 years | 0 Participants | 78 Participants | 78 Participants |
| Age, Customized Age 22 years | 0 Participants | 82 Participants | 82 Participants |
| Age, Customized Age 23 years | 0 Participants | 63 Participants | 63 Participants |
| Age, Customized Age 24 years | 0 Participants | 78 Participants | 78 Participants |
| Age, Customized Age 25 years | 0 Participants | 64 Participants | 64 Participants |
| Age, Customized Age 9 years | 72 Participants | 72 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 620 Participants | 1240 Participants | 620 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 620 | 1 / 620 | 1 / 620 | 0 / 620 |
| other Total, other adverse events | 71 / 620 | 166 / 620 | 62 / 620 | 73 / 620 |
| serious Total, serious adverse events | 2 / 620 | 13 / 620 | 3 / 620 | 34 / 620 |
Outcome results
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
Time frame: 24 months following initial vaccination
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | 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 | 20.6 International units (IU/mL) |
| Women (3D Gardasil-4®) | 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 | 48.8 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.36, 0.5]
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.
Time frame: 36 months following initial vaccination
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | 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 | 21.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | 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 | 42.9 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.44, 0.57]
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.
Time frame: 24 months following initial vaccination
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | 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 | 7.9 International units (IU/mL) |
| Women (3D Gardasil-4®) | 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 | 8.8 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.75, 1.08]
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.
Time frame: 36 months following initial vaccination
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | 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 | 8.0 International units (IU/mL) |
| Women (3D Gardasil-4®) | 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 | 7.2 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.95, 1.29]
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.
Time frame: 24 months following initial HPV vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 24 Months | 546 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 24 Months | 371 Participants |
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.
Time frame: 36 months following initial HPV vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 36 Months | 538 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 36 Months | 366 Participants |
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.
Time frame: 24 months following initial vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 24 Months | 521 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 24 Months | 367 Participants |
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.
Time frame: 36 months following initial vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 36 Months | 517 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 36 Months | 358 Participants |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 1 | 4.170 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 2 | 7.226 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 3 | 10.966 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 4 | 14.307 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 5 | 18.022 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 6 | 23.439 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 7 | 30.843 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 8 | 39.221 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 9 | 57.002 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 10 | 95.573 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 8 | 92.907 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 1 | 11.071 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 6 | 55.290 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 2 | 19.538 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 10 | 216.040 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 3 | 27.914 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 7 | 71.274 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 4 | 34.679 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 9 | 118.576 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months | Decile 5 | 41.836 International units (IU/mL) |
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.
Time frame: 36 months following initial vaccination
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 1 | 4.39 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 2 | 7.613 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 3 | 11.148 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 4 | 14.896 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 5 | 19.790 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 6 | 23.899 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 7 | 32.194 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 8 | 41.001 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 9 | 56.984 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 10 | 119.929 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 8 | 78.081 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 1 | 9.834 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 6 | 49.061 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 2 | 17.245 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 10 | 200.652 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 3 | 23.906 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 7 | 59.399 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 4 | 31.218 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 9 | 107.219 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months | Decile 5 | 39.034 International units (IU/mL) |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 1 | 1.568 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 2 | 2.757 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 3 | 4.259 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 4 | 5.465 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 5 | 7.183 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 6 | 9.274 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 7 | 11.425 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 8 | 15.207 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 9 | 21.259 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 10 | 39.083 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 8 | 16.287 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 1 | 1.563 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 6 | 10.326 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 2 | 2.993 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 10 | 58.887 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 3 | 4.118 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 7 | 12.739 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 4 | 5.470 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 9 | 26.680 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months | Decile 5 | 7.759 International units (IU/mL) |
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.
Time frame: 36 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 1 | 1.511 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 2 | 2.748 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 3 | 4.067 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 4 | 5.509 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 5 | 7.056 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 6 | 9.396 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 7 | 12.468 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 8 | 15.708 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 9 | 22.706 International units (IU/mL) |
| Girls (1D Cervarix®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 10 | 40.538 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 8 | 15.030 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 1 | 1.272 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 6 | 8.152 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 2 | 2.163 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 10 | 49.490 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 3 | 3.518 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 7 | 11.070 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 4 | 4.616 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 9 | 22.107 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months | Decile 5 | 6.156 International units (IU/mL) |
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 25.0 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 17.0 International units (IU/mL) |
95% CI: [1.2, 1.81]
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 83.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 62.6 International units (IU/mL) |
95% CI: [1.12, 1.58]
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | 22.0 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | 19.8 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | 53.2 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group | 42.0 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.33, 0.52]
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.37, 0.6]
p-value: =0.028p-values test for heterogeneity
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | 21.0 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | 46.3 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | 20.3 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District | 51.1 International units (IU/mL) |
99% CI: [0.32, 0.5]
p-value: =0.3p-values test for heterogeneity
99% CI: [0.36, 0.58]
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | 20.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | 47.9 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | 20.7 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group | 49.2 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.33, 0.55]
99% CI: [0.34, 0.52]
p-value: =0.95p-values test for heterogeneity
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | 21.7 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | 21.2 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | 47.1 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group | 36.7 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.38, 0.56]
96% CI: [0.48, 0.7]
p-value: =0.079p-values test for heterogeneity
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | 21.5 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | 41.0 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | 21.4 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District | 44.6 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.43, 0.64]
96% CI: [0.4, 0.58]
p-value: =0.46p-values test for heterogeneity
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | 21.6 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | 41.6 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | 21.3 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group | 43.6 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.43, 0.64]
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.41, 0.58]
p-value: =0.73The p-values test for heterogeneity
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 20.8 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 42.8 International units (IU/mL) |
96% CI: [0.42, 0.56]
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 20.0 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 48.8 International units (IU/mL) |
99% CI: [0.35, 0.49]
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 10.6 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 7.5 International units (IU/mL) |
95% CI: [1.15, 1.75]
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 32.8 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 25.4 International units (IU/mL) |
95% CI: [1.09, 1.54]
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | 8.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | 7.6 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | 9.9 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group | 7.6 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.65, 1.1]
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.77, 1.29]
p-value: =0.24The p-values test for heterogeneity
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | 8.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | 8.2 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | 7.6 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District | 9.4 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.79, 1.32]
99% CI: [0.63, 1.04]
p-value: =0.1p-values test for heterogeneity
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | 7.4 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | 8.2 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | 8.2 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group | 9.3 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.99% CI: [0.69, 1.19]
99% CI: [0.69, 1.14]
p-value: =0.88p-values test for heterogeneity
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.
Time frame: 24 months
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 7.6 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 8.8 International units (IU/mL) |
99% CI: [0.71, 1.04]
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | 8.1 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | 7.9 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | 8.0 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group | 6.4 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤0.05 because the null chance of rejection for either HPV16or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [0.82, 1.25]
Comparison: 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/HPV11.96% CI: [1.01, 1.54]
p-value: =0.14p-values test for heterogeneity
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | 8.5 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | 6.7 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | 7.7 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District | 7.7 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [1.03, 1.57]
96% CI: [0.8, 1.23]
p-value: =0.095p-values test for heterogeneity
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | 7.9 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | 6.3 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | 8.1 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group | 8.0 International units (IU/mL) |
Comparison: This procedure controls the overall type one error at 0.05. We are conducting 4 one-sided tests and will spend alpha as follows: 0.005 of the alpha each for HPV16 and for HPV18 at 24 months and 0.02 of the alpha each for HPV16 and for HPV18 at 36 months. The experiment-wise significance level accounting for multiple comparisons is ≤ 0.05 because the null chance of rejection for either HPV16 or HPV18 is ≤0.01 at 24 months by the Bonferroni inequality and ≤0.04 at 36 months.96% CI: [1, 1.58]
96% CI: [0.83, 1.24]
p-value: =0.15The p-values test for heterogeneity
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 7.9 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 7.2 International units (IU/mL) |
96% CI: [0.93, 1.27]
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.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months | 547 Participants |
| Women (3D Gardasil-4®) | Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months | 371 Participants |
p-value: =1Fisher Exact
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.
Time frame: 36 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months | 538 Participants |
| Women (3D Gardasil-4®) | Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months | 366 Participants |
p-value: =1Fisher Exact
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.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months | 521 Participants |
| Women (3D Gardasil-4®) | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months | 367 Participants |
p-value: =0.48Fisher Exact
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.
Time frame: 36 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months | 517 Participants |
| Women (3D Gardasil-4®) | Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months | 358 Participants |
p-value: =0.006Fisher Exact
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 85 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls | 462 Participants |
p-value: =1Fisher Exact
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.
Time frame: 1 month
Population: Since both groups had a 100% seroconversion proportion, p-value could not be calculated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 99 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 461 Participants |
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 461 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls | 366 Participants |
p-value: 1Fisher Exact
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | 211 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | 335 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | 229 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group | 142 Participants |
Comparison: NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 24months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).p-value: =1Fisher Exact
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | 253 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | 171 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | 293 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District | 200 Participants |
Comparison: NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.p-value: =1Fisher Exact
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | 196 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | 147 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | 350 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month | 224 Participants |
Comparison: NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 24 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.p-value: =1Fisher Exact
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 463 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls | 371 Participants |
p-value: =1Fisher Exact
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.
Time frame: 36 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | 203 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | 335 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | 226 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group | 140 Participants |
Comparison: NOTE: Younger one-dose recipients (9-11 Year Old Girls) and three-dose recipients (18-21 Year Old Women) both had a 100% seroconversion proportion for HPV16 at 36 months, so a p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between older one-dose recipients (9-11 Year Old Girls) and three-dose recipients (22-25 Year Old Women).p-value: =1Fisher Exact
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | 99.6 International units (IU/mL) |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | 100.0 International units (IU/mL) |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | 100.0 International units (IU/mL) |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District | 100.0 International units (IU/mL) |
Comparison: NOTE: One-dose recipients and three-dose recipients enrolled from mountainous districts both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate for HPV16 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.p-value: =1Fisher Exact
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | 195 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | 145 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | 343 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month | 221 Participants |
Comparison: NOTE: One-dose recipients and three-dose recipients enrolled April - May both had a 100% seroconversion proportion for HPV16 at 36 months, so the p-value for the difference of the seroconversion rate between them could not be calculated. Therefore, we only include the calculated p-value for the comparison of the seroconversion rate between one-dose recipients and three-dose recipients enrolled June - August.p-value: =1Fisher Exact
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.
Time frame: 1 year
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 84 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 440 Participants |
p-value: =0.368Fisher Exact
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.
Time frame: 1 month
Population: Since both groups had a 100% seroconversion proportion, p-value could not be calculated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 100 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls | 446 Participants |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 440 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls | 367 Participants |
p-value: =0.478Fisher Exact
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 441 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls | 358 Participants |
p-value: =0.0006Fisher Exact
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | 205 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | 316 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | 208 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group | 159 Participants |
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between younger one-dose recipients (9-12 Year Old Girls) and younger three-dose recipients (18-21 Year Old Women).p-value: =0.216Fisher Exact
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between older one-dose recipients (12-14 Year Old Girls) and older three-dose recipients (22-25 Year Old Women).p-value: =1Fisher Exact
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | 242 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | 161 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | 279 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District | 206 Participants |
Comparison: The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from coastal districts.p-value: =1Fisher Exact
Comparison: The calculated p-value for the comparison of the seroconversion rate for HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.p-value: =0.339Fisher Exact
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | 182 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | 154 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | 339 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month | 213 Participants |
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled April - May.p-value: =0.629Fisher Exact
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 24 months between one-dose recipients and three-dose recipients enrolled June - August.p-value: =0.175Fisher Exact
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | 199 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | 318 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | 201 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group | 157 Participants |
Comparison: Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between younger one-dose recipients (9-11 Year Old Girls) and the younger three-dose recipients (18-21 Year Old Women).p-value: =0.001Fisher Exact
Comparison: Calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between older one-dose recipients (12-14 Year Old Girls) and the older three-dose recipients (22-25 Year Old Women).p-value: =0.737Fisher Exact
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | 240 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | 157 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | 277 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District | 201 Participants |
Comparison: The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from coastal districts.p-value: =0.327Fisher Exact
Comparison: The calculated p-value for the comparison of the seroconversion rate for HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled from mountainous districts.p-value: =0.012Fisher Exact
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | 182 Participants |
| Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | 149 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | 335 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month | 209 Participants |
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled April - May.p-value: =0.253Fisher Exact
Comparison: The calculated p-value for the comparison of the seroconversion rate of HPV18 at 36 months between one-dose recipients and three-dose recipients enrolled June - August.p-value: =0.015Fisher Exact
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 85 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 462 Participants |
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 99 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 461 Participants |
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | 253 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | 171 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | 293 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District | 200 Participants |
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | 196 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | 147 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | 350 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month | 224 Participants |
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | 249 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | 169 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | 289 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District | 197 Participants |
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | 195 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | 145 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | 343 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group | 221 Participants |
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.
Time frame: 36 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | 211 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | 335 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | 229 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group | 142 Participants |
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds | 463 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds | 371 Participants |
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.
Time frame: 36 months
Population: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | 203 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | 335 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | 226 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group | 140 Participants |
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds | 461 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds | 366 Participants |
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.
Time frame: 12 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 84 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls | 440 Participants |
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.
Time frame: 1 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 100 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls | 446 Participants |
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | 242 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | 161 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | 279 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District | 206 Participants |
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
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | 182 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | 154 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | 339 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group | 213 Participants |
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | 240 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | 157 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | 277 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District | 201 Participants |
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
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | 182 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | 149 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | 335 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group | 209 Participants |
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.
Time frame: 24 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | 205 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | 316 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | 208 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group | 159 Participants |
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.
Time frame: 24 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds | 440 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds | 367 Participants |
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.
Time frame: 36 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | 199 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | 318 Participants |
| 18-21 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | 201 Participants |
| 22-25 Year Old Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group | 157 Participants |
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.
Time frame: 36 month
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Girls (1D Cervarix®) | Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds | 441 Participants |
| Women (3D Gardasil-4®) | Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds | 358 Participants |