Trial Outcomes & Findings for Single Dose of Cervarix Vaccine in Girls or Three Doses of Gardasil Vaccine in Women for the Prevention of Human Papillomavirus Infection, the PRIMAVERA-ESCUDDO Trial (NCT NCT03728881)

Last Updated: 2025-08-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1240 participants

Primary outcome timeframe

36 months following initial HPV vaccination

Results posted on

2025-08-03

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Girls (1D Cervarix®) Participants 9-14 years old receive Cervarix IM at baseline.	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.
Enrolled and Received 1st Vaccination STARTED	620	620
Enrolled and Received 1st Vaccination Received All Vaccines Within the ATP Windows (Gardasil® Arm Only)	0	559
Enrolled and Received 1st Vaccination No External HPV Vaccination Based on Self-report (Cervarix® Arm Only)	595	0
Enrolled and Received 1st Vaccination No External HPV Vaccination Based on HPV6/11 ELISA Results When Available (Cervarix® Arm Only)	585	0
Enrolled and Received 1st Vaccination Provided 36-month Blood in ATP Window	575	545
Enrolled and Received 1st Vaccination COMPLETED	575	545
Enrolled and Received 1st Vaccination NOT COMPLETED	45	75
ATP Cohort for HPV16 at 36 Months STARTED	575	545
ATP Cohort for HPV16 at 36 Months COMPLETED	539	366
ATP Cohort for HPV16 at 36 Months NOT COMPLETED	36	179
ATP Cohort for HPV18 at 36 Months STARTED	575	545
ATP Cohort for HPV18 at 36 Months COMPLETED	523	373
ATP Cohort for HPV18 at 36 Months NOT COMPLETED	52	172

Reasons for withdrawal

Reasons for withdrawal
Measure	Girls (1D Cervarix®) Participants 9-14 years old receive Cervarix IM at baseline.	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.
Enrolled and Received 1st Vaccination Adverse Event	0	1
Enrolled and Received 1st Vaccination Death	1	1
Enrolled and Received 1st Vaccination Withdrawal by Subject	5	8
Enrolled and Received 1st Vaccination Out of Country	1	3
Enrolled and Received 1st Vaccination No Show	0	1
Enrolled and Received 1st Vaccination Unable to appoint	3	12
Enrolled and Received 1st Vaccination Not fully vaccinated during ATP windows	0	49
Enrolled and Received 1st Vaccination Received HPV vaccination outside study (self-report)	25	0
Enrolled and Received 1st Vaccination HPV6/11 positive	10	0
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

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Girls (1D Cervarix®) n=620 Participants Participants 9-14 years old receive Cervarix IM at baseline.	Women (3D Gardasil-4®) n=620 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity.	Total n=1240 Participants Total of all reporting groups
Age, Customized Age · 9 years	72 Participants n=620 Participants	0 Participants n=620 Participants	72 Participants n=1240 Participants
Age, Customized Age · 10 years	44 Participants n=620 Participants	0 Participants n=620 Participants	44 Participants n=1240 Participants
Age, Customized Age · 11 years	137 Participants n=620 Participants	0 Participants n=620 Participants	137 Participants n=1240 Participants
Age, Customized Age · 12 years	126 Participants n=620 Participants	0 Participants n=620 Participants	126 Participants n=1240 Participants
Age, Customized Age · 13 years	126 Participants n=620 Participants	0 Participants n=620 Participants	126 Participants n=1240 Participants
Age, Customized Age · 14 years	115 Participants n=620 Participants	0 Participants n=620 Participants	115 Participants n=1240 Participants
Age, Customized Age · 18 years	0 Participants n=620 Participants	75 Participants n=620 Participants	75 Participants n=1240 Participants
Age, Customized Age · 19 years	0 Participants n=620 Participants	98 Participants n=620 Participants	98 Participants n=1240 Participants
Age, Customized Age · 20 years	0 Participants n=620 Participants	82 Participants n=620 Participants	82 Participants n=1240 Participants
Age, Customized Age · 21 years	0 Participants n=620 Participants	78 Participants n=620 Participants	78 Participants n=1240 Participants
Age, Customized Age · 22 years	0 Participants n=620 Participants	82 Participants n=620 Participants	82 Participants n=1240 Participants
Age, Customized Age · 23 years	0 Participants n=620 Participants	63 Participants n=620 Participants	63 Participants n=1240 Participants
Age, Customized Age · 24 years	0 Participants n=620 Participants	78 Participants n=620 Participants	78 Participants n=1240 Participants
Age, Customized Age · 25 years	0 Participants n=620 Participants	64 Participants n=620 Participants	64 Participants n=1240 Participants
Sex: Female, Male Female	620 Participants n=620 Participants	620 Participants n=620 Participants	1240 Participants n=1240 Participants
Sex: Female, Male Male	0 Participants n=620 Participants	0 Participants n=620 Participants	0 Participants n=1240 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=539 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 36 Months	538 Participants	366 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=538 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
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) Interval 19.7 to 23.3	42.9 International units (IU/mL) Interval 38.9 to 47.3	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=523 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=373 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 36 Months	517 Participants	358 Participants	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=517 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=358 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
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) Interval 7.4 to 8.8	7.2 International units (IU/mL) Interval 6.4 to 8.1	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=547 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 24 Months	546 Participants	371 Participants	—	—

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=546 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
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) Interval 19.0 to 22.4	48.8 International units (IU/mL) Interval 44.4 to 53.7	—	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=530 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=376 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 24 Months	521 Participants	367 Participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=521 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=367 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
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) Interval 0.7 to 8.6	8.8 International units (IU/mL) Interval 7.9 to 9.9	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=539 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Proportions With Seroconversion Based on HPV16 Antibody Levels Assessed at 36 Months	538 Participants	366 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=523 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=373 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 36 Months	517 Participants	358 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=547 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Proportions With Seroconversion Based HPV16 Antibody Levels at 24 Months	547 Participants	371 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=530 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=376 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Proportions With Seroconversion Based on HPV18 Antibody Levels Assessed at 24 Months	521 Participants	367 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=539 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 1	4.39 International units (IU/mL) Interval 0.7 to 5.852	9.834 International units (IU/mL) Interval 0.7 to 13.625	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 2	7.613 International units (IU/mL) Interval 5.853 to 9.357	17.245 International units (IU/mL) Interval 13.626 to 20.329	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 3	11.148 International units (IU/mL) Interval 9.358 to 12.952	23.906 International units (IU/mL) Interval 20.33 to 27.172	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 4	14.896 International units (IU/mL) Interval 12.953 to 16.892	31.218 International units (IU/mL) Interval 27.173 to 34.459	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 5	19.790 International units (IU/mL) Interval 16.893 to 21.527	39.034 International units (IU/mL) Interval 34.46 to 43.235	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 6	23.899 International units (IU/mL) Interval 21.528 to 26.399	49.061 International units (IU/mL) Interval 43.236 to 53.882	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 7	32.194 International units (IU/mL) Interval 26.4 to 37.1	59.399 International units (IU/mL) Interval 53.883 to 69.789	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 8	41.001 International units (IU/mL) Interval 37.101 to 45.715	78.081 International units (IU/mL) Interval 69.79 to 88.011	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 9	56.984 International units (IU/mL) Interval 45.716 to 75.071	107.219 International units (IU/mL) Interval 88.012 to 140.529	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 36 Months Decile 10	119.929 International units (IU/mL) Interval 75.072 to 529.494	200.652 International units (IU/mL) Interval 140.26 to 555.91	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=523 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=373 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 1	1.511 International units (IU/mL) Interval 0.52 to 2.267	1.272 International units (IU/mL) Interval 0.52 to 1.824	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 2	2.748 International units (IU/mL) Interval 2.268 to 3.498	2.163 International units (IU/mL) Interval 1.825 to 2.723	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 3	4.067 International units (IU/mL) Interval 3.499 to 4.962	3.518 International units (IU/mL) Interval 2.724 to 3.885	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 4	5.509 International units (IU/mL) Interval 4.963 to 6.188	4.616 International units (IU/mL) Interval 3.886 to 5.279	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 5	7.056 International units (IU/mL) Interval 6.189 to 8.04	6.156 International units (IU/mL) Interval 5.28 to 7.043	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 6	9.396 International units (IU/mL) Interval 8.041 to 10.551	8.152 International units (IU/mL) Interval 7.004 to 9.681	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 7	12.468 International units (IU/mL) Interval 10.552 to 14.101	11.070 International units (IU/mL) Interval 9.682 to 13.141	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 8	15.708 International units (IU/mL) Interval 14.102 to 17.605	15.030 International units (IU/mL) Interval 13.142 to 17.911	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 9	22.706 International units (IU/mL) Interval 17.606 to 29.016	22.107 International units (IU/mL) Interval 17.912 to 36.612	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 36 Months Decile 10	40.538 International units (IU/mL) Interval 29.017 to 369.78	49.490 International units (IU/mL) Interval 32.613 to 168.932	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=547 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 1	4.170 International units (IU/mL) Interval 0.7 to 5.78	11.071 International units (IU/mL) Interval 0.7 to 14.744	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 2	7.226 International units (IU/mL) Interval 5.781 to 9.277	19.538 International units (IU/mL) Interval 14.745 to 23.657	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 3	10.966 International units (IU/mL) Interval 9.278 to 12.39	27.914 International units (IU/mL) Interval 23.658 to 30.979	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 4	14.307 International units (IU/mL) Interval 12.391 to 16.16	34.679 International units (IU/mL) Interval 30.98 to 38.266	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 5	18.022 International units (IU/mL) Interval 16.161 to 20.408	41.836 International units (IU/mL) Interval 38.267 to 47.324	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 6	23.439 International units (IU/mL) Interval 20.409 to 26.986	55.290 International units (IU/mL) Interval 47.325 to 63.38	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 7	30.843 International units (IU/mL) Interval 26.987 to 33.419	71.274 International units (IU/mL) Interval 63.381 to 81.015	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 8	39.221 International units (IU/mL) Interval 33.42 to 46.278	92.907 International units (IU/mL) Interval 81.016 to 102.904	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 9	57.002 International units (IU/mL) Interval 46.279 to 68.773	118.576 International units (IU/mL) Interval 102.905 to 154.382	—	—
Comparison of Distribution of HPV16 Antibodies Levels Assessed at 24 Months Decile 10	95.573 International units (IU/mL) Interval 68.774 to 428.103	216.040 International units (IU/mL) Interval 154.383 to 1006.328	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=530 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=376 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 1	1.568 International units (IU/mL) Interval 0.52 to 2.169	1.563 International units (IU/mL) Interval 0.52 to 2.274	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 2	2.757 International units (IU/mL) Interval 2.17 to 3.537	2.993 International units (IU/mL) Interval 2.275 to 3.661	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 3	4.259 International units (IU/mL) Interval 3.538 to 4.876	4.118 International units (IU/mL) Interval 3.662 to 4.853	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 4	5.465 International units (IU/mL) Interval 4.844 to 6.11	5.470 International units (IU/mL) Interval 4.854 to 6.465	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 5	7.183 International units (IU/mL) Interval 6.111 to 8.105	7.759 International units (IU/mL) Interval 6.466 to 8.832	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 6	9.274 International units (IU/mL) Interval 8.106 to 10.373	10.326 International units (IU/mL) Interval 8.833 to 11.59	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 7	11.425 International units (IU/mL) Interval 10.374 to 13.536	12.739 International units (IU/mL) Interval 11.591 to 14.51	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 8	15.207 International units (IU/mL) Interval 13.537 to 18.026	16.287 International units (IU/mL) Interval 14.511 to 20.471	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 9	21.259 International units (IU/mL) Interval 18.027 to 28.251	26.680 International units (IU/mL) Interval 20.472 to 39.323	—	—
Comparison of Distribution of HPV18 Antibodies Levels Assessed at 24 Months Decile 10	39.083 International units (IU/mL) Interval 28.252 to 182.221	58.887 International units (IU/mL) Interval 39.324 to 264.857	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=462 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 36 Months, Excluding 9-10 Year Olds	461 Participants	366 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=461 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls	20.8 International units (IU/mL) Interval 19.0 to 22.8	42.8 International units (IU/mL) Interval 38.8 to 47.2	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=462 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=366 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16 Antibodies Assessed at 36 Months, Excluding 9-10-year-old Girls	461 Participants	366 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=447 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=373 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 36 Months, Excluding 9-10 Year Olds	441 Participants	358 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=441 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=358 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls	7.9 International units (IU/mL) Interval 7.2 to 8.7	7.2 International units (IU/mL) Interval 6.4 to 8.1	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=447 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=373 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 36 Months, Excluding 9-10-year-old Girls	441 Participants	358 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=464 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 24 Months, Excluding 9-10 Year Olds	463 Participants	371 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=463 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls	20.0 International units (IU/mL) Interval 18.3 to 21.9	48.8 International units (IU/mL) Interval 44.4 to 53.7	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=464 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=371 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16 Assessed at 24 Months, Excluding 9-10-year-old Girls	463 Participants	371 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=448 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=376 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 24 Months, Excluding 9-10 Year Olds	440 Participants	367 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=440 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=367 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls	7.6 International units (IU/mL) Interval 6.9 to 8.3	8.8 International units (IU/mL) Interval 7.9 to 9.9	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=448 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=376 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 24 Months, Excluding 9-10-year-old Girls	440 Participants	367 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=99 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=461 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls	99 Participants	461 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=99 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=461 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls	83.4 International units (IU/mL) Interval 71.2 to 97.8	62.6 International units (IU/mL) Interval 58.3 to 67.3	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Since both groups had a 100% seroconversion proportion, p-value could not be calculated.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=99 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=461 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls	99 Participants	461 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=100 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=446 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 Antibodies, Assessed at 1 Month After Vaccination, in Younger and Older Girls	100 Participants	446 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=100 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=446 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls	32.8 International units (IU/mL) Interval 28.2 to 38.2	25.4 International units (IU/mL) Interval 23.3 to 27.6	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Since both groups had a 100% seroconversion proportion, p-value could not be calculated.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=100 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=446 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 1 Month After Vaccination in Younger and Older Girls	100 Participants	446 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=85 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=464 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls	85 Participants	462 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=85 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=462 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls	25.0 International units (IU/mL) Interval 20.7 to 30.2	17.0 International units (IU/mL) Interval 15.5 to 18.6	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=85 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=464 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls	85 Participants	462 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=84 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=448 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls	84 Participants	440 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=84 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=440 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 12 Months After Vaccination in Younger and Older Girls	10.6 International units (IU/mL) Interval 8.8 to 12.9	7.5 International units (IU/mL) Interval 6.9 to 8.2	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=84 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=448 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18 Antibodies, Assessed at 12 Months After Vaccination, in Younger and Older Girls	84 Participants	440 Participants	—	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=203 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=336 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=226 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=140 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 36 Months, By Enrollment Age Group	203 Participants	335 Participants	226 Participants	140 Participants

SECONDARY outcome

Timeframe: 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.

To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 36 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=203 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=335 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=226 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=140 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Age Group	21.7 International units (IU/mL) Interval 19.1 to 24.6	21.2 International units (IU/mL) Interval 19.0 to 23.6	47.1 International units (IU/mL) Interval 41.5 to 53.4	36.7 International units (IU/mL) Interval 31.7 to 42.5

SECONDARY outcome

Timeframe: 36 month

To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=203 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=336 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=226 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=140 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Age Group	203 Participants	335 Participants	226 Participants	140 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=199 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=324 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=212 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=161 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 36 Months, By Enrollment Age Group	199 Participants	318 Participants	201 Participants	157 Participants

SECONDARY outcome

Timeframe: 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.

To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 36 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=199 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=318 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=201 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=157 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Age Group	8.1 International units (IU/mL) Interval 7.2 to 9.2	7.9 International units (IU/mL) Interval 7.1 to 8.9	8.0 International units (IU/mL) Interval 6.8 to 9.5	6.4 International units (IU/mL) Interval 5.4 to 7.5

SECONDARY outcome

Timeframe: 36 month

To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 36 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=199 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=324 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=212 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=161 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Age Group	199 Participants	318 Participants	201 Participants	157 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=211 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=336 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=229 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=142 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16 at 24 Months, By Enrollment Age Group	211 Participants	335 Participants	229 Participants	142 Participants

SECONDARY outcome

Timeframe: 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.

To evaluate whether age is associated with GMCs for HPV16 antibodies, assessed at 24 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=211 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=335 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=229 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=142 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Age Group	22.0 International units (IU/mL) Interval 19.3 to 25.0	19.8 International units (IU/mL) Interval 17.8 to 22.0	53.2 International units (IU/mL) Interval 47.1 to 60.1	42.0 International units (IU/mL) Interval 36.2 to 48.7

SECONDARY outcome

Timeframe: 24 month

To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=211 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=336 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=229 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=142 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Age Group	211 Participants	335 Participants	229 Participants	142 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=206 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=324 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=213 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=163 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18 at 24 Months, By Enrollment Age Group	205 Participants	316 Participants	208 Participants	159 Participants

SECONDARY outcome

Timeframe: 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.

To evaluate whether age is associated with GMCs for HPV18 antibodies, assessed at 24 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=205 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=316 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=208 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=159 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment Age Group	8.4 International units (IU/mL) Interval 7.4 to 9.5	7.6 International units (IU/mL) Interval 6.8 to 8.5	9.9 International units (IU/mL) Interval 8.5 to 11.5	7.6 International units (IU/mL) Interval 6.5 to 8.9

SECONDARY outcome

Timeframe: 24 month

To evaluate whether age is associated with seroconversion proportions for HPV-16 antibodies, assessed at 24 months after initial vaccination.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=206 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=324 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=213 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=163 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Age Group	205 Participants	316 Participants	208 Participants	159 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=195 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=145 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=344 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=221 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment Month Group	195 Participants	145 Participants	343 Participants	221 Participants

SECONDARY outcome

Timeframe: 36 month

HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=195 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=145 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=343 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=221 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies Assessed at 36 Months, by Enrollment Month Group	21.6 International units (IU/mL) Interval 18.8 to 24.8	41.6 International units (IU/mL) Interval 36.3 to 47.7	21.3 International units (IU/mL) Interval 19.2 to 23.6	43.6 International units (IU/mL) Interval 38.2 to 49.7

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=195 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=145 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=344 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=221 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment Month	195 Participants	145 Participants	343 Participants	221 Participants

SECONDARY outcome

Timeframe: 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.

HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=184 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=154 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=339 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=219 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment Month Group	182 Participants	149 Participants	335 Participants	209 Participants

SECONDARY outcome

Timeframe: 36 month

HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=182 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=149 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=335 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=209 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment Month Group	7.9 International units (IU/mL) Interval 6.8 to 9.1	6.3 International units (IU/mL) Interval 5.3 to 7.4	8.1 International units (IU/mL) Interval 7.3 to 9.1	8.0 International units (IU/mL) Interval 6.8 to 9.4

SECONDARY outcome

Timeframe: 36 month

HPV18 ELISA results at 36-months (final analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=184 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=154 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=339 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=219 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment Month	182 Participants	149 Participants	335 Participants	209 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=196 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=147 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=351 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=224 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment Month	196 Participants	147 Participants	350 Participants	224 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=196 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=147 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=350 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=224 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies Assessed at 24 Months, by Enrollment Month Group	20.4 International units (IU/mL) Interval 17.9 to 23.4	47.9 International units (IU/mL) Interval 41.8 to 54.8	20.7 International units (IU/mL) Interval 18.7 to 22.9	49.2 International units (IU/mL) Interval 43.4 to 55.9

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=196 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=147 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=351 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=224 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment Month	196 Participants	147 Participants	350 Participants	224 Participants

SECONDARY outcome

Timeframe: 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.

HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=185 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=155 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=345 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=221 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment Month Group	182 Participants	154 Participants	339 Participants	213 Participants

SECONDARY outcome

Timeframe: 24 month

HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=182 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=154 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=339 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=213 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies Assessed at 24 Months, by Enrollment Month Group	7.4 International units (IU/mL) Interval 6.5 to 8.5	8.2 International units (IU/mL) Interval 7.0 to 9.6	8.2 International units (IU/mL) Interval 7.4 to 9.2	9.3 International units (IU/mL) Interval 7.9 to 10.8

SECONDARY outcome

Timeframe: 24 month

HPV18 ELISA results at 24-months (interim analysis) by arm in according to protocol (ATP) analytical cohort, stratified by enrollment month

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=185 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=155 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=345 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=221 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment Month	182 Participants	154 Participants	339 Participants	213 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=250 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=169 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=289 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=197 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16, Assessed at 36 Months, by Enrollment District	249 Participants	169 Participants	289 Participants	197 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=249 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=169 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=289 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=197 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies, Assessed at 36 Months, by Enrollment District	21.5 International units (IU/mL) Interval 19.0 to 24.3	41.0 International units (IU/mL) Interval 35.7 to 47.1	21.4 International units (IU/mL) Interval 19.1 to 24.0	44.6 International units (IU/mL) Interval 38.9 to 51.0

SECONDARY outcome

Timeframe: 36 month

HPV16 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=250 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=169 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=289 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=197 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 36 Months, by Enrollment District	99.6 International units (IU/mL) Interval 98.1 to 100.0	100.0 International units (IU/mL) Interval 98.2 to 100.0	100.0 International units (IU/mL) Interval 99.0 to 100.0	100.0 International units (IU/mL) Interval 98.5 to 100.0

SECONDARY outcome

Timeframe: 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.

HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=244 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=163 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=279 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=210 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18, Assessed at 36 Months, by Enrollment District	240 Participants	157 Participants	277 Participants	201 Participants

SECONDARY outcome

Timeframe: 36 month

HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=240 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=157 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=277 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=201 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 36 Months, by Enrollment District	8.5 International units (IU/mL) Interval 7.5 to 9.5	6.7 International units (IU/mL) Interval 5.7 to 7.8	7.7 International units (IU/mL) Interval 6.8 to 8.7	7.7 International units (IU/mL) Interval 6.6 to 9.1

SECONDARY outcome

Timeframe: 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.

HPV18 ELISA results at 36-months (final analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=244 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=163 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=279 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=210 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 36 Months, by Enrollment District	240 Participants	157 Participants	277 Participants	201 Participants

SECONDARY outcome

Timeframe: 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.

HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=254 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=171 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=293 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=200 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV16, Assessed at 24 Months, by Enrollment District	253 Participants	171 Participants	293 Participants	200 Participants

SECONDARY outcome

Timeframe: 24 month

HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=253 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=171 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=293 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=200 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV16 Antibodies, Assessed at 24 Months, by Enrollment District	21.0 International units (IU/mL) Interval 18.5 to 23.7	46.3 International units (IU/mL) Interval 40.5 to 53.0	20.3 International units (IU/mL) Interval 18.3 to 22.7	51.1 International units (IU/mL) Interval 44.8 to 58.4

SECONDARY outcome

Timeframe: 24 month

HPV16 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=254 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=171 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=293 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=200 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV16, Assessed at 24 Months, by Enrollment District	253 Participants	171 Participants	293 Participants	200 Participants

SECONDARY outcome

Timeframe: 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.

HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=247 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=164 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=283 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=212 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Number Seropositive for HPV18, Assessed at 24 Months, by Enrollment District	242 Participants	161 Participants	279 Participants	206 Participants

SECONDARY outcome

Timeframe: 24 month

HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=242 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=161 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=279 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=206 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of GMCs for HPV18 Antibodies, Assessed at 24 Months, by Enrollment District	8.4 International units (IU/mL) Interval 7.4 to 9.5	8.2 International units (IU/mL) Interval 7.0 to 9.5	7.6 International units (IU/mL) Interval 6.7 to 8.5	9.4 International units (IU/mL) Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: 24 month

HPV18 ELISA results at 24-months (interim analysis) by arm in the according to protocol analytical cohort stratified by enrollment region.

Outcome measures

Outcome measures
Measure	Girls (1D Cervarix®) n=247 Participants Participants 9-14 years old receive Cervarix IM at baseline. Recombinant Human Papillomavirus Bivalent Vaccine: Given IM	Women (3D Gardasil-4®) n=164 Participants Participants 18-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	18-21 Year Old Women (3D Gardasil-4®) n=283 Participants Participants 18-21 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM	22-25 Year Old Women (3D Gardasil-4®) n=212 Participants Participants 22-25 years old receive Gardasil IM at baseline and at 2 and 6 months in the absence of unacceptable toxicity. Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine: Given IM
Comparison of Seroconversion Proportions for HPV18, Assessed at 24 Months, by Enrollment District	242 Participants	161 Participants	279 Participants	206 Participants

Adverse Events

Girls (1D Cervarix®) Systematic Collection Phase

Serious events: 2 serious events

Other events: 71 other events

Deaths: 0 deaths

Women (3D Gardasil-4®) Systematic Collection Phase

Serious events: 13 serious events

Other events: 166 other events

Deaths: 1 deaths

Girls (1D Cervarix®) Non-systematic Collection Phase

Serious events: 3 serious events

Other events: 62 other events

Deaths: 1 deaths

Women (3D Gardasil-4®) Non-systematic Collection Phase

Serious events: 34 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Aimée R. Kreimer, PhD

Division of Cancer Epidemiology and Genetics, NCI

Phone: 240.276.7102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60