Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls (NCT NCT01381575)

Last Updated: 2020-06-09

Results Overview

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1447 participants

Primary outcome timeframe

At Month 7 (i.e. one month after the last dose of study vaccine)

Results posted on

2020-06-09

Participant Flow

This study was conducted by 33 principal investigators in five countries (Canada, Germany, Italy, Taiwan and Thailand).

All 1447 subjects enrolled in the study were vaccinated and included in the Total vaccinated cohort (TVC).

Participant milestones

Participant milestones
Measure	Cervarix 1 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Study STARTED	550	482	415
Overall Study COMPLETED	524	443	395
Overall Study NOT COMPLETED	26	39	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix 1 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Overall Study Serious Adverse Event	1	0	0
Overall Study Non-Serious Adverse Event	0	0	1
Overall Study Protocol Violation	0	1	1
Overall Study Withdrawal by Subject	15	9	7
Overall Study Migrated/moved from study area	2	12	2
Overall Study Lost to Follow-up	8	17	9

Baseline Characteristics

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Total n=1447 Participants Total of all reporting groups
Age, Continuous	11.6 Years STANDARD_DEVIATION 1.59 • n=5 Participants	19.6 Years STANDARD_DEVIATION 3.05 • n=7 Participants	11.4 Years STANDARD_DEVIATION 1.55 • n=5 Participants	14.2 Years STANDARD_DEVIATION 4.40 • n=4 Participants
Sex: Female, Male Female	550 Participants n=5 Participants	482 Participants n=7 Participants	415 Participants n=5 Participants	1447 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized African Heritage / African American	6 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	141 Participants n=5 Participants	105 Participants n=7 Participants	74 Participants n=5 Participants	320 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	108 Participants n=5 Participants	106 Participants n=7 Participants	104 Participants n=5 Participants	318 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	288 Participants n=5 Participants	263 Participants n=7 Participants	223 Participants n=5 Participants	774 Participants n=4 Participants
Race/Ethnicity, Customized Mixed origin	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Month 7 (i.e. one month after the last dose of study vaccine)

Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=493 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=382 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 Anti-HPV-16	488 Participants	352 Participants	—
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 Anti-HPV-18	493 Participants	382 Participants	—

PRIMARY outcome

Timeframe: At Month 7 (i.e. one month after the last dose of study vaccine)

Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=493 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=382 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 Anti-HPV-16	9400.1 EL.U/mL Interval 8818.3 to 10020.4	10234.5 EL.U/mL Interval 9258.3 to 11313.6	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 Anti-HPV-18	5909.1 EL.U/mL Interval 5508.9 to 6338.4	5002.6 EL.U/mL Interval 4572.6 to 5473.1	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 18, 24 and 36

Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0, Month 7 and Month 12 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=462 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=356 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Day 0	0 Participants	0 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 7	455 Participants	330 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 12	455 Participants	330 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 18	453 Participants	329 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 24	454 Participants	326 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 36	455 Participants	330 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Day 0	0 Participants	0 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 7	462 Participants	356 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 12	462 Participants	356 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 18	458 Participants	355 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 24	459 Participants	352 Participants	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 36	461 Participants	355 Participants	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 18, 24 and 36

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=462 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=356 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 36	1210.2 EL.U/mL Interval 1124.8 to 1302.1	1326.4 EL.U/mL Interval 1193.9 to 1473.5	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Day 0	4.0 EL.U/mL Interval 4.0 to 4.0	4.0 EL.U/mL Interval 4.0 to 4.0	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 7	9402.9 EL.U/mL Interval 8792.4 to 10055.8	10120.2 EL.U/mL Interval 9162.7 to 11177.9	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 12	2653.5 EL.U/mL Interval 2473.5 to 2846.6	3290.4 EL.U/mL Interval 2956.5 to 3662.0	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 18	1730.7 EL.U/mL Interval 1608.6 to 1862.0	1931.2 EL.U/mL Interval 1735.4 to 2149.1	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-16, Month 24	1483.8 EL.U/mL Interval 1382.1 to 1592.9	1575.9 EL.U/mL Interval 1418.2 to 1751.2	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Day 0	3.5 EL.U/mL Interval 3.5 to 3.5	3.5 EL.U/mL Interval 3.5 to 3.5	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 7	5935.6 EL.U/mL Interval 5519.4 to 6383.3	4984.2 EL.U/mL Interval 4543.9 to 5467.1	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 12	1523.6 EL.U/mL Interval 1403.7 to 1653.7	1491.5 EL.U/mL Interval 1339.0 to 1661.4	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 18	864.6 EL.U/mL Interval 793.1 to 942.7	830.6 EL.U/mL Interval 742.9 to 928.5	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 24	715.5 EL.U/mL Interval 658.1 to 777.9	654.3 EL.U/mL Interval 582.9 to 734.5	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 Anti-HPV-18, Month 36	562.8 EL.U/mL Interval 516.4 to 613.4	552.6 EL.U/mL Interval 494.1 to 618.0	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18, 24 and 36

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0 and Month 13 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=355 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-16, Day 0	0 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-16, Month 13	339 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-16, Month 18	339 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-16, Month 24	337 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-16, Month 36	339 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-18, Day 0	0 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-18, Month 13	355 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-18, Month 18	355 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-18, Month 24	353 Participants	—	—
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group Anti-HPV-18, Month 36	355 Participants	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18, 24 and 36

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=355 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-16, Day 0	4.0 EL.U/mL Interval 4.0 to 4.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-16, Month 13	11329.4 EL.U/mL Interval 10509.3 to 12213.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-16, Month 18	3248.2 EL.U/mL Interval 2974.2 to 3547.4	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-16, Month 24	2191.0 EL.U/mL Interval 2003.9 to 2395.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-16, Month 36	1559.3 EL.U/mL Interval 1431.2 to 1699.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-18, Day 0	3.5 EL.U/mL Interval 3.5 to 3.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-18, Month 13	6580.0 EL.U/mL Interval 6075.8 to 7126.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-18, Month 18	1860.3 EL.U/mL Interval 1699.4 to 2036.4	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-18, Month 24	1174.7 EL.U/mL Interval 1067.1 to 1293.2	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group Anti-HPV-18, Month 36	804.0 EL.U/mL Interval 731.8 to 883.4	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18, 24 and 36

Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=88 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-16, Day 0	20.0 Titers Interval 20.0 to 20.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-16, Month 13	74848.0 Titers Interval 60521.9 to 92565.1	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-16, Month 18	16576.6 Titers Interval 13127.4 to 20932.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-16, Month 24	10003.7 Titers Interval 8114.1 to 12333.4	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-16, Month 36	9214.3 Titers Interval 7112.3 to 11937.5	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-18, Day 0	20.0 Titers Interval 20.0 to 20.0	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-18, Month 13	39994.7 Titers Interval 33327.2 to 47996.1	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-18, Month 18	9495.4 Titers Interval 7744.4 to 11642.2	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-18, Month 24	5464.1 Titers Interval 4377.8 to 6819.8	—	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group Anti-HPV-18, Month 36	4046.4 Titers Interval 3278.0 to 4994.8	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 18, 24 and 36

Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=96 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=92 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Day 0	21.3 Titers Interval 18.8 to 24.2	23.5 Titers Interval 20.7 to 26.6	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Month 7	82975.9 Titers Interval 67377.4 to 102185.6	31407.6 Titers Interval 24181.5 to 40793.0	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Month 12	14872.1 Titers Interval 12025.5 to 18392.4	15801.8 Titers Interval 12069.8 to 20687.8	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Month 18	7393.6 Titers Interval 5986.6 to 9131.1	8246.4 Titers Interval 6224.6 to 10925.0	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Month 24	6216.5 Titers Interval 5111.0 to 7561.1	7267.5 Titers Interval 5423.4 to 9738.6	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-16, Month 36	7762.7 Titers Interval 6218.6 to 9690.1	5063.7 Titers Interval 3800.4 to 6746.9	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Day 0	21.0 Titers Interval 19.0 to 23.5	22.4 Titers Interval 20.4 to 24.5	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Month 7	24833.1 Titers Interval 20777.0 to 29681.1	13935.6 Titers Interval 10991.0 to 17669.0	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Month 12	5914.5 Titers Interval 4756.0 to 7355.4	5066.5 Titers Interval 3818.9 to 6721.7	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Month 18	3961.2 Titers Interval 3153.8 to 4975.4	2958.2 Titers Interval 2213.9 to 3952.6	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Month 24	2849.4 Titers Interval 2276.0 to 3567.2	2524.3 Titers Interval 1860.4 to 3425.2	—
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group Anti-HPV-18, Month 36	2416.4 Titers Interval 1905.9 to 3063.5	1956.2 Titers Interval 1488.5 to 2570.7	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 24 and 36

Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

The CMI response represents the measure of the cytokines production \[i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)\] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=84 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=70 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Day 0	88.0 cells/million T cells Interval 62.0 to 152.0	120.0 cells/million T cells Interval 67.0 to 185.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 7	3953.0 cells/million T cells Interval 1866.0 to 7025.0	3426.0 cells/million T cells Interval 1889.0 to 5214.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 12	2491.0 cells/million T cells Interval 1387.5 to 5543.5	2278.5 cells/million T cells Interval 1225.0 to 3363.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 24	2698.0 cells/million T cells Interval 1231.0 to 5147.0	2401.0 cells/million T cells Interval 1231.0 to 3641.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 36	1951.0 cells/million T cells Interval 1085.0 to 5130.0	2073.0 cells/million T cells Interval 1012.0 to 2836.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Day 0	77.5 cells/million T cells Interval 57.0 to 192.0	100.0 cells/million T cells Interval 60.0 to 269.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 7	5019.5 cells/million T cells Interval 1353.0 to 7343.0	1820.0 cells/million T cells Interval 1311.0 to 3021.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 12	2603.0 cells/million T cells Interval 1003.0 to 3350.0	1423.5 cells/million T cells Interval 876.0 to 3747.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 24	2552.0 cells/million T cells Interval 1156.0 to 3963.0	1404.0 cells/million T cells Interval 1050.0 to 2856.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 36	2180.0 cells/million T cells Interval 1293.0 to 3383.0	1310.0 cells/million T cells Interval 939.0 to 2614.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Day 0	70.0 cells/million T cells Interval 42.0 to 130.0	97.0 cells/million T cells Interval 49.0 to 144.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 7	3531.0 cells/million T cells Interval 1676.0 to 6528.0	3196.0 cells/million T cells Interval 1692.0 to 4771.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 12	2439.5 cells/million T cells Interval 1342.5 to 5376.0	2255.5 cells/million T cells Interval 1185.0 to 3290.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 24	2443.0 cells/million T cells Interval 1111.0 to 4922.0	2344.0 cells/million T cells Interval 1031.0 to 3323.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 36	1935.0 cells/million T cells Interval 1048.0 to 5061.0	2027.0 cells/million T cells Interval 978.0 to 2806.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Day 0	57.5 cells/million T cells Interval 39.5 to 162.0	72.5 cells/million T cells Interval 40.0 to 186.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 7	4979.5 cells/million T cells Interval 1290.5 to 7001.5	1655.0 cells/million T cells Interval 1050.0 to 2440.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 12	2587.0 cells/million T cells Interval 975.0 to 3305.0	1412.5 cells/million T cells Interval 832.0 to 3677.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 24	2456.0 cells/million T cells Interval 945.0 to 3931.0	1285.0 cells/million T cells Interval 962.5 to 1953.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 36	2109.0 cells/million T cells Interval 1178.0 to 3343.0	1279.0 cells/million T cells Interval 928.0 to 2496.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Day 0	44.0 cells/million T cells Interval 19.0 to 67.0	39.5 cells/million T cells Interval 19.5 to 72.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 7	840.0 cells/million T cells Interval 503.0 to 1538.0	657.0 cells/million T cells Interval 474.0 to 1185.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 12	546.0 cells/million T cells Interval 176.5 to 1007.5	362.0 cells/million T cells Interval 202.0 to 644.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 24	644.5 cells/million T cells Interval 294.0 to 1318.0	449.0 cells/million T cells Interval 204.0 to 884.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 36	562.0 cells/million T cells Interval 273.0 to 1334.0	391.0 cells/million T cells Interval 215.0 to 824.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Day 0	38.5 cells/million T cells Interval 26.5 to 86.0	50.5 cells/million T cells Interval 31.0 to 75.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 7	881.5 cells/million T cells Interval 462.5 to 2704.0	489.0 cells/million T cells Interval 244.0 to 814.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 12	533.0 cells/million T cells Interval 336.0 to 827.0	329.0 cells/million T cells Interval 183.0 to 481.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 24	579.0 cells/million T cells Interval 398.0 to 897.0	310.5 cells/million T cells Interval 221.5 to 595.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 36	651.0 cells/million T cells Interval 520.0 to 998.0	564.0 cells/million T cells Interval 185.5 to 714.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Day 0	59.0 cells/million T cells Interval 35.0 to 103.0	85.5 cells/million T cells Interval 43.5 to 143.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 7	3808.0 cells/million T cells Interval 1728.0 to 6787.0	3212.5 cells/million T cells Interval 1788.0 to 5010.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 12	2402.5 cells/million T cells Interval 1308.5 to 5242.0	2184.5 cells/million T cells Interval 1156.0 to 3238.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 24	2477.0 cells/million T cells Interval 1140.0 to 4680.0	2282.0 cells/million T cells Interval 1138.0 to 3392.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 36	1881.0 cells/million T cells Interval 958.0 to 4912.0	1922.0 cells/million T cells Interval 892.0 to 2708.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Day 0	68.0 cells/million T cells Interval 23.0 to 147.5	77.5 cells/million T cells Interval 39.0 to 229.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 7	4886.0 cells/million T cells Interval 1162.5 to 6906.0	1573.0 cells/million T cells Interval 1202.0 to 2924.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 12	2339.0 cells/million T cells Interval 877.0 to 3166.0	1372.0 cells/million T cells Interval 868.0 to 3692.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 24	2454.0 cells/million T cells Interval 1026.0 to 3931.0	1226.5 cells/million T cells Interval 969.0 to 2392.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 36	2135.0 cells/million T cells Interval 1221.0 to 3291.0	1243.0 cells/million T cells Interval 910.5 to 2382.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Day 0	59.0 cells/million T cells Interval 37.0 to 93.0	68.0 cells/million T cells Interval 29.5 to 110.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 7	2474.0 cells/million T cells Interval 1311.0 to 4800.0	2575.5 cells/million T cells Interval 1224.0 to 3675.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 12	1944.0 cells/million T cells Interval 814.5 to 4150.0	1726.0 cells/million T cells Interval 919.0 to 2481.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 24	2181.5 cells/million T cells Interval 886.0 to 4177.0	1970.0 cells/million T cells Interval 773.0 to 2758.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 36	1595.0 cells/million T cells Interval 700.0 to 3836.0	1390.0 cells/million T cells Interval 672.0 to 2092.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Day 0	47.0 cells/million T cells Interval 32.0 to 131.0	64.0 cells/million T cells Interval 49.0 to 120.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 7	2058.5 cells/million T cells Interval 1047.0 to 3933.0	1273.0 cells/million T cells Interval 949.0 to 2372.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 12	1826.0 cells/million T cells Interval 875.0 to 2703.0	1171.0 cells/million T cells Interval 733.0 to 2828.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 24	1851.0 cells/million T cells Interval 1039.0 to 2259.0	1061.5 cells/million T cells Interval 878.5 to 2421.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 36	1138.0 cells/million T cells Interval 1031.0 to 2506.0	1057.0 cells/million T cells Interval 732.0 to 2009.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Day 0	11.0 cells/million T cells Interval 11.0 to 41.0	11.0 cells/million T cells Interval 11.0 to 44.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 7	11.0 cells/million T cells Interval 11.0 to 41.0	11.0 cells/million T cells Interval 11.0 to 36.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8 all doubles, S-, Month 12	30.5 cells/million T cells Interval 11.0 to 45.5	29.5 cells/million T cells Interval 11.0 to 50.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 24	11.0 cells/million T cells Interval 11.0 to 53.0	11.0 cells/million T cells Interval 11.0 to 54.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 36	37.0 cells/million T cells Interval 11.0 to 72.0	35.0 cells/million T cells Interval 11.0 to 59.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Day 0	11.0 cells/million T cells Interval 11.0 to 49.0	35.5 cells/million T cells Interval 26.0 to 41.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 7	11.0 cells/million T cells Interval 11.0 to 30.5	33.0 cells/million T cells Interval 11.0 to 43.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8 all doubles, S+, Month 12	52.0 cells/million T cells Interval 49.0 to 77.0	29.0 cells/million T cells Interval 11.0 to 57.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 24	49.0 cells/million T cells Interval 12.0 to 63.0	11.0 cells/million T cells Interval 11.0 to 56.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 36	27.0 cells/million T cells Interval 11.0 to 123.0	11.0 cells/million T cells Interval 11.0 to 49.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 32.0	7.0 cells/million T cells Interval 7.0 to 37.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 31.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 36	11.0 cells/million T cells Interval 7.0 to 52.0	7.0 cells/million T cells Interval 7.0 to 32.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 22.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 12	45.0 cells/million T cells Interval 7.0 to 48.0	15.0 cells/million T cells Interval 7.0 to 37.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 46.0	7.0 cells/million T cells Interval 7.0 to 17.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 27.0	7.0 cells/million T cells Interval 7.0 to 15.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 32.0	7.0 cells/million T cells Interval 7.0 to 37.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 35.0	7.0 cells/million T cells Interval 7.0 to 26.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 38.0	7.0 cells/million T cells Interval 7.0 to 46.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 37.0	7.0 cells/million T cells Interval 7.0 to 42.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 36	11.0 cells/million T cells Interval 7.0 to 44.0	25.0 cells/million T cells Interval 7.0 to 44.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 45.0	31.5 cells/million T cells Interval 22.0 to 37.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	22.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 12	46.0 cells/million T cells Interval 31.0 to 54.0	15.0 cells/million T cells Interval 7.0 to 40.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 24	8.0 cells/million T cells Interval 7.0 to 46.0	7.0 cells/million T cells Interval 7.0 to 23.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 63.0	7.0 cells/million T cells Interval 7.0 to 45.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 30.0	7.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 28.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 12	7.0 cells/million T cells Interval 7.0 to 31.0	7.0 cells/million T cells Interval 7.0 to 23.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 45.0	7.0 cells/million T cells Interval 7.0 to 13.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 36	7 cells/million T cells Interval 7.0 to 23.0	7 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 29.0	7.0 cells/million T cells Interval 7.0 to 28.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 33.0	7.0 cells/million T cells Interval 7.0 to 32.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 38.0	7.0 cells/million T cells Interval 7.0 to 33.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 37.0	7.0 cells/million T cells Interval 7.0 to 24.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 36	7 cells/million T cells Interval 7.0 to 36.0	7 cells/million T cells Interval 7.0 to 32.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 30.5	14.5 cells/million T cells Interval 7.0 to 31.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 26.5	22.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 12	8.0 cells/million T cells Interval 7.0 to 54.0	23.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 24	8.0 cells/million T cells Interval 7.0 to 42.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 119.0	7.0 cells/million T cells Interval 7.0 to 7.0	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 24 and 36

The CMI response represents the measure of the cytokines production \[IL-2, IFN-γ, TNF-α, and CD40L\] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=83 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=72 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Day 0	86.0 cells/million T cells Interval 61.0 to 129.0	112.0 cells/million T cells Interval 75.0 to 177.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 7	2780.0 cells/million T cells Interval 1606.0 to 4289.0	1864.0 cells/million T cells Interval 1158.0 to 2565.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 12	2039.0 cells/million T cells Interval 1053.0 to 3481.0	1246.5 cells/million T cells Interval 814.0 to 2045.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 24	1815.5 cells/million T cells Interval 877.5 to 3193.0	1355.0 cells/million T cells Interval 638.5 to 2106.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 36	1609.0 cells/million T cells Interval 716.0 to 3322.0	1246.0 cells/million T cells Interval 676.5 to 1751.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Day 0	125.0 cells/million T cells Interval 61.0 to 227.0	128.0 cells/million T cells Interval 71.0 to 153.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 7	1593.0 cells/million T cells Interval 786.0 to 4012.0	1498.0 cells/million T cells Interval 808.0 to 2727.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 12	868.0 cells/million T cells Interval 576.0 to 2069.0	787.0 cells/million T cells Interval 597.0 to 1771.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 24	710.5 cells/million T cells Interval 523.0 to 2329.0	885.0 cells/million T cells Interval 475.5 to 2147.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 36	808.5 cells/million T cells Interval 624.0 to 1764.0	598.0 cells/million T cells Interval 367.0 to 1414.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Day 0	62.0 cells/million T cells Interval 35.0 to 105.0	88.0 cells/million T cells Interval 49.0 to 155.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 7	2634.0 cells/million T cells Interval 1331.0 to 3748.0	1700.0 cells/million T cells Interval 993.0 to 2324.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 12	1967.0 cells/million T cells Interval 1019.0 to 3362.0	1206.5 cells/million T cells Interval 797.5 to 2006.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 24	1632.0 cells/million T cells Interval 807.0 to 3133.0	1290.5 cells/million T cells Interval 600.5 to 1911.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 36	1543.0 cells/million T cells Interval 686.0 to 3258.0	1222.0 cells/million T cells Interval 670.0 to 1665.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Day 0	121.0 cells/million T cells Interval 50.0 to 223.0	110.5 cells/million T cells Interval 44.0 to 142.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 7	1419.0 cells/million T cells Interval 729.0 to 3704.0	1377.0 cells/million T cells Interval 703.0 to 2511.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 12	830.0 cells/million T cells Interval 572.0 to 2008.0	767.0 cells/million T cells Interval 539.0 to 1724.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 24	652.0 cells/million T cells Interval 475.0 to 2151.0	867.0 cells/million T cells Interval 431.0 to 1963.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 36	794.0 cells/million T cells Interval 604.0 to 1721.0	594.0 cells/million T cells Interval 350.0 to 1356.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Day 0	32.0 cells/million T cells Interval 19.0 to 55.0	32.0 cells/million T cells Interval 19.0 to 68.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 7	562.0 cells/million T cells Interval 220.0 to 952.0	350.0 cells/million T cells Interval 192.0 to 554.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 12	354.0 cells/million T cells Interval 132.0 to 669.0	216.5 cells/million T cells Interval 111.5 to 390.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 24	326.5 cells/million T cells Interval 166.5 to 799.5	205.5 cells/million T cells Interval 108.5 to 538.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 36	304.5 cells/million T cells Interval 168.5 to 757.0	233.5 cells/million T cells Interval 114.5 to 485.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Day 0	55.0 cells/million T cells Interval 19.0 to 70.0	28.0 cells/million T cells Interval 19.0 to 48.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 7	628.0 cells/million T cells Interval 186.0 to 1186.0	376.0 cells/million T cells Interval 234.0 to 580.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 12	244.5 cells/million T cells Interval 120.0 to 535.0	161.0 cells/million T cells Interval 85.0 to 344.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 24	295.5 cells/million T cells Interval 108.0 to 636.0	270.5 cells/million T cells Interval 94.5 to 455.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 36	356.0 cells/million T cells Interval 278.0 to 417.0	239.0 cells/million T cells Interval 102.0 to 422.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Day 0	57.0 cells/million T cells Interval 30.0 to 96.0	81.0 cells/million T cells Interval 36.0 to 127.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 7	2611.0 cells/million T cells Interval 1452.0 to 3953.0	1725.0 cells/million T cells Interval 1026.0 to 2329.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 12	1959.0 cells/million T cells Interval 1009.0 to 3269.0	1172.5 cells/million T cells Interval 755.5 to 1916.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 24	1638.5 cells/million T cells Interval 851.5 to 3084.0	1306.0 cells/million T cells Interval 589.0 to 1977.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 36	1495.0 cells/million T cells Interval 661.0 to 3065.0	1183.5 cells/million T cells Interval 586.5 to 1684.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Day 0	65.0 cells/million T cells Interval 31.0 to 137.0	96.5 cells/million T cells Interval 48.0 to 102.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 7	1470.0 cells/million T cells Interval 691.0 to 3887.0	1231.0 cells/million T cells Interval 690.0 to 2313.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 12	847.5 cells/million T cells Interval 556.0 to 2022.0	783.0 cells/million T cells Interval 514.0 to 1650.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 24	652.5 cells/million T cells Interval 448.0 to 2269.0	705.5 cells/million T cells Interval 433.0 to 2041.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 36	777.0 cells/million T cells Interval 589.0 to 1669.0	554.0 cells/million T cells Interval 333.0 to 1370.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Day 0	49.0 cells/million T cells Interval 31.0 to 72.0	73.0 cells/million T cells Interval 27.0 to 138.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 7	1699.0 cells/million T cells Interval 979.0 to 2832.0	1394.0 cells/million T cells Interval 824.0 to 2060.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 12	1573.0 cells/million T cells Interval 715.0 to 2662.0	991.0 cells/million T cells Interval 599.0 to 1617.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 24	1434.0 cells/million T cells Interval 637.5 to 2506.0	1102.5 cells/million T cells Interval 543.0 to 1580.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 36	1268.0 cells/million T cells Interval 473.5 to 2130.0	868.5 cells/million T cells Interval 520.0 to 1296.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Day 0	51.0 cells/million T cells Interval 44.0 to 159.0	68.0 cells/million T cells Interval 32.0 to 137.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 7	1337.0 cells/million T cells Interval 437.0 to 3141.0	1137.0 cells/million T cells Interval 648.0 to 2211.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 12	604.0 cells/million T cells Interval 391.0 to 1696.0	684.0 cells/million T cells Interval 443.0 to 1284.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 24	601.0 cells/million T cells Interval 462.0 to 2122.0	768.5 cells/million T cells Interval 370.5 to 1673.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 36	652.5 cells/million T cells Interval 489.0 to 1590.0	444.0 cells/million T cells Interval 294.0 to 996.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Day 0	11.0 cells/million T cells Interval 11.0 to 36.0	11.0 cells/million T cells Interval 11.0 to 33.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 7	11.0 cells/million T cells Interval 11.0 to 37.0	11.0 cells/million T cells Interval 11.0 to 32.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8 all doubles, S-, Month 12	28.0 cells/million T cells Interval 11.0 to 47.0	37.0 cells/million T cells Interval 11.0 to 51.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 24	11.0 cells/million T cells Interval 11.0 to 51.0	11.0 cells/million T cells Interval 11.0 to 43.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 36	32.0 cells/million T cells Interval 11.0 to 45.5	29.0 cells/million T cells Interval 11.0 to 51.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Day 0	11.0 cells/million T cells Interval 11.0 to 27.0	11.0 cells/million T cells Interval 11.0 to 34.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 7	11.0 cells/million T cells Interval 11.0 to 78.0	11.0 cells/million T cells Interval 11.0 to 73.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8 all doubles, S+, Month 12	44.0 cells/million T cells Interval 11.0 to 73.0	11.0 cells/million T cells Interval 11.0 to 33.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 24	19.5 cells/million T cells Interval 11.0 to 47.0	11.0 cells/million T cells Interval 11.0 to 36.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 36	45.0 cells/million T cells Interval 11.0 to 85.0	34.0 cells/million T cells Interval 11.0 to 50.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 32.0	7.0 cells/million T cells Interval 7.0 to 36.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 35.5	7.0 cells/million T cells Interval 7.0 to 37.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 27.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 12	34.5 cells/million T cells Interval 7.0 to 48.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 36	25.0 cells/million T cells Interval 7.0 to 61.0	7.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 29.0	7.0 cells/million T cells Interval 7.0 to 24.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 26.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 34.0	7.0 cells/million T cells Interval 7.0 to 39.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 29.5	7.0 cells/million T cells Interval 7.0 to 33.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 40.5	7.0 cells/million T cells Interval 7.0 to 34.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 23.0	7.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 74.0	7.0 cells/million T cells Interval 7.0 to 39.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 12	16.0 cells/million T cells Interval 7.0 to 38.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 9.0	7.0 cells/million T cells Interval 7.0 to 32.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 39.0	7.0 cells/million T cells Interval 7.0 to 40.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 26.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 27.0	7.0 cells/million T cells Interval 7.0 to 14.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 24.0	7.0 cells/million T cells Interval 7.0 to 34.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 12	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 23.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 24.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 39.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	7.0 cells/million T cells Interval 7.0 to 8.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 7	7.0 cells/million T cells Interval 7.0 to 31.0	7.0 cells/million T cells Interval 7.0 to 27.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 12	7.0 cells/million T cells Interval 7.0 to 31.0	7.0 cells/million T cells Interval 7.0 to 35.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 24	7.0 cells/million T cells Interval 7.0 to 32.5	7.0 cells/million T cells Interval 7.0 to 33.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 32.0	7.0 cells/million T cells Interval 7.0 to 35.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 23.0	7.0 cells/million T cells Interval 7.0 to 30.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 7	7.0 cells/million T cells Interval 7.0 to 74.0	7.0 cells/million T cells Interval 7.0 to 62.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 12	7.0 cells/million T cells Interval 7.0 to 38.0	7.0 cells/million T cells Interval 7.0 to 7.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 24	7.0 cells/million T cells Interval 7.0 to 31.0	7.0 cells/million T cells Interval 7.0 to 16.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 36	17.0 cells/million T cells Interval 7.0 to 57.0	7.0 cells/million T cells Interval 7.0 to 29.0	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18 and 36

Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=77 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Day 0	96.0 cells/million T cells Interval 61.0 to 170.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 13	2399.0 cells/million T cells Interval 1514.0 to 4223.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 18	1879.0 cells/million T cells Interval 1124.0 to 3449.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S-, Month 36	1786.5 cells/million T cells Interval 1064.0 to 3285.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Day 0	169.0 cells/million T cells Interval 77.0 to 277.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 13	2507.5 cells/million T cells Interval 1067.0 to 4212.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 18	2717.5 cells/million T cells Interval 1597.0 to 4103.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4 all doubles, S+, Month 36	1521.0 cells/million T cells Interval 297.0 to 3794.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Day 0	89.0 cells/million T cells Interval 48.0 to 133.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 13	2356.0 cells/million T cells Interval 1510.0 to 4165.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 18	1831.0 cells/million T cells Interval 1070.0 to 3272.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S-, Month 36	1763.0 cells/million T cells Interval 1048.0 to 3239.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Day 0	141.0 cells/million T cells Interval 73.0 to 261.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 13	2450.5 cells/million T cells Interval 1036.0 to 4139.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 18	2614.5 cells/million T cells Interval 1580.0 to 3862.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-CD40L, S+, Month 36	1426.0 cells/million T cells Interval 280.0 to 3697.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Day 0	35.0 cells/million T cells Interval 20.0 to 60.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 13	651.0 cells/million T cells Interval 328.0 to 1356.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 18	405.0 cells/million T cells Interval 208.0 to 821.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S-, Month 36	646.0 cells/million T cells Interval 276.0 to 1282.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Day 0	68.0 cells/million T cells Interval 33.0 to 203.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 13	644.0 cells/million T cells Interval 204.0 to 1163.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 18	708.5 cells/million T cells Interval 361.0 to 1218.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IFNγ, S+, Month 36	310.0 cells/million T cells Interval 72.0 to 1783.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Day 0	63.0 cells/million T cells Interval 34.0 to 111.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 13	2220.0 cells/million T cells Interval 1406.0 to 4107.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 18	1830.0 cells/million T cells Interval 1084.0 to 3221.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S-, Month 36	1670.5 cells/million T cells Interval 1009.0 to 3169.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Day 0	121.0 cells/million T cells Interval 47.0 to 191.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 13	2442.0 cells/million T cells Interval 835.0 to 4006.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 18	2659.5 cells/million T cells Interval 1510.0 to 3870.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-IL-2, S+, Month 36	1028.0 cells/million T cells Interval 267.0 to 3629.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Day 0	63.0 cells/million T cells Interval 37.0 to 99.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 13	1643.0 cells/million T cells Interval 907.0 to 2988.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 18	1326.0 cells/million T cells Interval 807.0 to 2627.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S-, Month 36	1300.5 cells/million T cells Interval 693.0 to 2267.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Day 0	140.0 cells/million T cells Interval 32.0 to 164.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 13	1843.0 cells/million T cells Interval 584.0 to 2657.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 18	2085.0 cells/million T cells Interval 1380.0 to 2700.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD4-d-TNFα, S+, Month 36	1202.0 cells/million T cells Interval 169.0 to 2745.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Day 0	27.0 cells/million T cells Interval 11.0 to 54.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 13	11.0 cells/million T cells Interval 11.0 to 43.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 18	11.0 cells/million T cells Interval 11.0 to 53.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S-, Month 36	21.5 cells/million T cells Interval 11.0 to 52.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Day 0	33.0 cells/million T cells Interval 11.0 to 59.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 13	43.0 cells/million T cells Interval 11.0 to 57.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 18	27.0 cells/million T cells Interval 11.0 to 52.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-all doubles, S+, Month 36	11.0 cells/million T cells Interval 11.0 to 89.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 35.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 13	7.0 cells/million T cells Interval 7.0 to 29.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 18	7.0 cells/million T cells Interval 7.0 to 34.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 30.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 35.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 13	7.0 cells/million T cells Interval 7.0 to 34.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 18	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-CD40L, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 46.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 44.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 13	7.0 cells/million T cells Interval 7.0 to 35.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 18	7.0 cells/million T cells Interval 7.0 to 37.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 38.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Day 0	29.0 cells/million T cells Interval 7.0 to 55.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 13	25.5 cells/million T cells Interval 7.0 to 53.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 18	7.0 cells/million T cells Interval 7.0 to 33.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IFNγ, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 46.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 13	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 18	7.0 cells/million T cells Interval 7.0 to 29.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 13	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 18	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-IL-2, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 46.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Day 0	7.0 cells/million T cells Interval 7.0 to 27.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 13	7.0 cells/million T cells Interval 7.0 to 29.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 18	7.0 cells/million T cells Interval 7.0 to 41.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S-, Month 36	7.0 cells/million T cells Interval 7.0 to 38.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Day 0	7.0 cells/million T cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 13	20.5 cells/million T cells Interval 7.0 to 44.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 18	20.0 cells/million T cells Interval 7.0 to 39.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, CD8-d-TNFα, S+, Month 36	7.0 cells/million T cells Interval 7.0 to 7.0	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18 and 36

The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=82 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Day 0	99.0 cells/million T-cells Interval 61.0 to 149.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 13	1499.0 cells/million T-cells Interval 1033.0 to 2928.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 18	1222.0 cells/million T-cells Interval 796.0 to 2116.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S-, Month 36	1158.0 cells/million T-cells Interval 606.0 to 2185.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Day 0	107.5 cells/million T-cells Interval 69.0 to 146.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 13	1968.5 cells/million T-cells Interval 1753.0 to 2184.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 18	1250.0 cells/million T-cells Interval 1156.0 to 1344.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4 all doubles, S+, Month 36	1399.5 cells/million T-cells Interval 1004.0 to 1795.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Day 0	82.5 cells/million T-cells Interval 42.0 to 125.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 13	1472.0 cells/million T-cells Interval 1003.0 to 2880.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 18	1199.0 cells/million T-cells Interval 748.0 to 2098.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S-, Month 36	1154.0 cells/million T-cells Interval 563.0 to 2157.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Day 0	103.5 cells/million T-cells Interval 65.0 to 142.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 13	1904.5 cells/million T-cells Interval 1656.0 to 2153.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 18	1174.5 cells/million T-cells Interval 1110.0 to 1239.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-CD40L, S+, Month 36	1320.0 cells/million T-cells Interval 918.0 to 1722.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Day 0	35.0 cells/million T-cells Interval 23.0 to 61.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 13	349.0 cells/million T-cells Interval 173.0 to 1221.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 18	226.0 cells/million T-cells Interval 108.0 to 575.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S-, Month 36	318.0 cells/million T-cells Interval 140.0 to 766.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Day 0	33.5 cells/million T-cells Interval 24.0 to 43.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 13	378.0 cells/million T-cells Interval 307.0 to 449.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 18	157.5 cells/million T-cells Interval 136.0 to 179.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IFNγ, S+, Month 36	389.0 cells/million T-cells Interval 231.0 to 547.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Day 0	58.5 cells/million T-cells Interval 32.0 to 98.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 13	1398.0 cells/million T-cells Interval 812.0 to 2743.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 18	1102.0 cells/million T-cells Interval 719.0 to 1924.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S-, Month 36	1086.0 cells/million T-cells Interval 535.0 to 1974.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Day 0	46.5 cells/million T-cells Interval 33.0 to 60.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 13	1845.0 cells/million T-cells Interval 1544.0 to 2146.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 18	1151.0 cells/million T-cells Interval 1078.0 to 1224.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-IL-2, S+, Month 36	1160.0 cells/million T-cells Interval 827.0 to 1493.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Day 0	60.5 cells/million T-cells Interval 34.0 to 97.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 13	1029.0 cells/million T-cells Interval 649.0 to 2051.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 18	921.0 cells/million T-cells Interval 539.0 to 1783.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S-, Month 36	812.0 cells/million T-cells Interval 384.0 to 1545.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Day 0	66.5 cells/million T-cells Interval 29.0 to 104.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 13	1449.5 cells/million T-cells Interval 1317.0 to 1582.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 18	954.5 cells/million T-cells Interval 873.0 to 1036.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD4-d-TNFα, S+, Month 36	1127.0 cells/million T-cells Interval 847.0 to 1407.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Day 0	11.0 cells/million T-cells Interval 11.0 to 47.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 13	32.0 cells/million T-cells Interval 11.0 to 49.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 18	34.0 cells/million T-cells Interval 11.0 to 50.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S-, Month 36	33.0 cells/million T-cells Interval 11.0 to 56.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Day 0	29.0 cells/million T-cells Interval 11.0 to 47.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 13	63.5 cells/million T-cells Interval 39.0 to 88.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 18	11.0 cells/million T-cells Interval 11.0 to 11.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-all doubles, S+, Month 36	45.0 cells/million T-cells Interval 11.0 to 79.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Day 0	7.0 cells/million T-cells Interval 7.0 to 30.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 13	7.0 cells/million T-cells Interval 7.0 to 38.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 18	7.0 cells/million T-cells Interval 7.0 to 34.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S-, Month 36	7.0 cells/million T-cells Interval 7.0 to 38.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Day 0	25.0 cells/million T-cells Interval 7.0 to 43.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 13	21.0 cells/million T-cells Interval 7.0 to 35.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 18	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-CD40L, S+, Month 36	41.0 cells/million T-cells Interval 7.0 to 75.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Day 0	7.0 cells/million T-cells Interval 7.0 to 41.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 13	7.0 cells/million T-cells Interval 7.0 to 40.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 18	7.0 cells/million T-cells Interval 7.0 to 37.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S-, Month 36	7.0 cells/million T-cells Interval 7.0 to 44.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Day 0	25.0 cells/million T-cells Interval 7.0 to 43.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 13	59.5 cells/million T-cells Interval 35.0 to 84.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 18	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IFNγ, S+, Month 36	41.0 cells/million T-cells Interval 7.0 to 75.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Day 0	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 13	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 18	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S-, Month 36	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Day 0	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 13	45.5 cells/million T-cells Interval 7.0 to 84.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 18	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-IL-2, S+, Month 36	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Day 0	7.0 cells/million T-cells Interval 7.0 to 38.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 13	7.0 cells/million T-cells Interval 7.0 to 30.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 18	7.0 cells/million T-cells Interval 7.0 to 40.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S-, Month 36	7.0 cells/million T-cells Interval 7.0 to 35.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Day 0	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 13	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 18	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, CD8-d-TNFα, S+, Month 36	7.0 cells/million T-cells Interval 7.0 to 7.0	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 24 and 36

The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=75 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=63 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Day 0	1.0 cells/million B-cells Interval 1.0 to 1.0	1.0 cells/million B-cells Interval 1.0 to 1.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 7	2155.0 cells/million B-cells Interval 886.0 to 5421.0	1510.0 cells/million B-cells Interval 799.0 to 3114.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 12	801.0 cells/million B-cells Interval 361.0 to 2648.0	1145.0 cells/million B-cells Interval 371.0 to 3215.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 24	318.0 cells/million B-cells Interval 95.0 to 697.0	594.5 cells/million B-cells Interval 147.5 to 1133.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 36	560.5 cells/million B-cells Interval 157.0 to 1012.0	448.0 cells/million B-cells Interval 219.0 to 821.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Day 0	1.0 cells/million B-cells Interval 1.0 to 16.0	1.0 cells/million B-cells Interval 1.0 to 51.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 7	4838.0 cells/million B-cells Interval 1513.0 to 11824.0	477.0 cells/million B-cells Interval 139.0 to 4928.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 12	5056.0 cells/million B-cells Interval 5018.0 to 5094.0	539.0 cells/million B-cells Interval 340.0 to 2111.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 24	621.0 cells/million B-cells Interval 324.5 to 1751.5	568.5 cells/million B-cells Interval 50.0 to 1955.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 36	475.0 cells/million B-cells Interval 414.0 to 822.0	107.0 cells/million B-cells Interval 1.0 to 1275.0	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 7, 12, 24 and 36

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=72 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=63 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Day 0	1.0 cells/million B-cells Interval 1.0 to 1.0	1.0 cells/million B-cells Interval 1.0 to 1.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 7	958.0 cells/million B-cells Interval 386.0 to 2500.0	817.5 cells/million B-cells Interval 368.0 to 1894.5	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 24	236.0 cells/million B-cells Interval 61.5 to 710.0	274.0 cells/million B-cells Interval 71.0 to 829.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 36	269.0 cells/million B-cells Interval 62.0 to 732.0	284.5 cells/million B-cells Interval 90.0 to 582.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Day 0	1.0 cells/million B-cells Interval 1.0 to 44.0	1.0 cells/million B-cells Interval 1.0 to 22.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 7	2016.5 cells/million B-cells Interval 423.0 to 2797.0	439.5 cells/million B-cells Interval 31.0 to 1779.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 24	299.0 cells/million B-cells Interval 117.0 to 643.0	338.5 cells/million B-cells Interval 174.0 to 786.0	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 36	154.0 cells/million B-cells Interval 141.0 to 427.0	93.0 cells/million B-cells Interval 18.0 to 762.0	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18 and 36

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=68 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Day 0	1.0 cells/million B-cells Interval 1.0 to 7.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 13	2809.5 cells/million B-cells Interval 1402.5 to 5045.5	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 18	766.0 cells/million B-cells Interval 412.0 to 1946.5	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S-, Month 36	613.0 cells/million B-cells Interval 322.0 to 1301.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Day 0	1.0 cells/million B-cells Interval 1.0 to 20.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 13	5996.0 cells/million B-cells Interval 919.0 to 7353.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 18	2130.0 cells/million B-cells Interval 808.0 to 2271.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-16, S+, Month 36	425.0 cells/million B-cells Interval 102.0 to 714.0	—	—

SECONDARY outcome

Timeframe: At Day 0 and at Months 13, 18 and 36

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=72 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 13	1165.0 cells/million B-cells Interval 602.0 to 1660.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 18	561.5 cells/million B-cells Interval 132.0 to 1213.5	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Month 36	361.0 cells/million B-cells Interval 112.0 to 724.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Day 0	48.0 cells/million B-cells Interval 48.0 to 48.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 13	758.0 cells/million B-cells Interval 114.0 to 1402.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 18	938.0 cells/million B-cells Interval 938.0 to 938.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S+, Month 36	1231.0 cells/million B-cells Interval 1231.0 to 1231.0	—	—
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects Anti-HPV-18, S-, Day 0	1.0 cells/million B-cells Interval 1.0 to 1.0	—	—

SECONDARY outcome

Timeframe: During the 7-day period (Days 0-6) after each vaccine dose and across doses

Population: The analysis was based on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=480 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=413 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness - Dose 2	180 Participants	143 Participants	153 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness - Dose 2	4 Participants	5 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness - Dose 3	—	142 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness - Dose 3	—	5 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness - Across doses	247 Participants	212 Participants	197 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness - Across doses	4 Participants	10 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling - Dose 1	141 Participants	105 Participants	101 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling - Dose 1	3 Participants	1 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling - Dose 2	166 Participants	131 Participants	135 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling - Dose 2	2 Participants	4 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling - Dose 3	—	136 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling - Dose 3	—	3 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling - Across doses	225 Participants	204 Participants	171 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling - Across doses	5 Participants	6 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain - Dose 1	461 Participants	439 Participants	354 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain - Dose 1	24 Participants	21 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain - Dose 2	446 Participants	377 Participants	323 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain - Dose 2	33 Participants	25 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain - Dose 3	—	358 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain - Dose 3	—	20 Participants	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain - Across doses	499 Participants	461 Participants	381 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain - Across doses	50 Participants	53 Participants	48 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness - Dose 1	167 Participants	135 Participants	126 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness - Dose 1	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 7-day period (Days 0-6) after each vaccine dose and across doses

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=480 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=413 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash - Across doses	26 Participants	18 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever - Dose 1	24 Participants	17 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever - Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever - Dose 1	15 Participants	12 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever - Dose 2	21 Participants	15 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever - Dose 2	1 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever - Dose 2	17 Participants	12 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever - Dose 3	—	29 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever - Dose 3	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever - Dose 3	—	25 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever - Across doses	41 Participants	48 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever - Across doses	2 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever - Across doses	29 Participants	39 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria - Dose 1	9 Participants	7 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria - Dose 1	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria - Dose 1	7 Participants	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria - Dose 2	7 Participants	9 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria - Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria - Dose 2	6 Participants	7 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria - Dose 3	—	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria - Dose 3	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria - Dose 3	—	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria - Across doses	15 Participants	15 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria - Across doses	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria - Across doses	13 Participants	11 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Artharlgia - Dose 1	61 Participants	53 Participants	52 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia - Dose 1	8 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia - Dose 1	56 Participants	50 Participants	45 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia - Dose 2	64 Participants	50 Participants	57 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Artharlgia - Dose 2	71 Participants	56 Participants	64 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia - Dose 2	2 Participants	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Artharlgia - Dose 3	—	49 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia - Dose 3	—	3 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia - Dose 3	—	42 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Artharlgia - Across doses	111 Participants	107 Participants	93 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia - Across doses	9 Participants	6 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia - Across doses	105 Participants	102 Participants	83 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue - Dose 1	181 Participants	238 Participants	156 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue - Dose 1	7 Participants	9 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue - Dose 1	153 Participants	205 Participants	129 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue - Dose 2	167 Participants	168 Participants	144 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue - Dose 2	9 Participants	11 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue - Dose 2	149 Participants	142 Participants	119 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue - Dose 3	—	177 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue - Dose 3	—	12 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue - Dose 3	—	161 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue - Across doses	247 Participants	310 Participants	215 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue - Across doses	14 Participants	25 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue - Across doses	221 Participants	294 Participants	185 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal - Dose 1	59 Participants	88 Participants	44 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal - Dose 1	1 Participants	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal - Dose 1	49 Participants	67 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal - Dose 2	51 Participants	50 Participants	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal - Dose 2	6 Participants	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal - Dose 2	34 Participants	36 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal - Dose 3	—	45 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal - Dose 3	—	7 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal - Dose 3	—	35 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal - Across doses	98 Participants	134 Participants	77 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal - Across doses	7 Participants	11 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal - Across doses	77 Participants	106 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache - Dose 1	133 Participants	161 Participants	128 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache - Dose 1	9 Participants	10 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache - Dose 1	104 Participants	136 Participants	104 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache - Dose 2	128 Participants	129 Participants	130 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache - Dose 2	14 Participants	5 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache - Dose 2	107 Participants	108 Participants	100 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache - Dose 3	—	124 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache - Dose 3	—	11 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache - Dose 3	—	106 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache - Across doses	204 Participants	246 Participants	185 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache - Across doses	19 Participants	26 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache - Across doses	176 Participants	219 Participants	148 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia - Dose 1	206 Participants	236 Participants	160 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia - Dose 1	16 Participants	12 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia - Dose 1	191 Participants	223 Participants	140 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia - Dose 2	196 Participants	182 Participants	150 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia - Dose 2	13 Participants	11 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia - Dose 2	182 Participants	171 Participants	136 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia - Dose 3	—	158 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia - Dose 3	—	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia - Dose 3	—	150 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia - Across doses	278 Participants	295 Participants	221 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia - Across doses	24 Participants	25 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia - Across doses	265 Participants	285 Participants	201 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash - Dose 1	17 Participants	8 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash - Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash - Dose 1	13 Participants	5 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash - Dose 2	17 Participants	11 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash - Dose 2	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash - Dose 2	13 Participants	10 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash - Dose 3	—	8 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash - Dose 3	—	0 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash - Dose 3	—	5 Participants	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash - Across doses	33 Participants	25 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash - Across doses	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 30 day (Days 0-29) post-vaccination period

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any unsolicited AEs	97 Participants	167 Participants	74 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 unsolicited AEs	2 Participants	17 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related unsolicited AEs	11 Participants	24 Participants	13 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available. The data for Cervarix 1 and 2 Groups are only presented up to Month 13, as the data were only collected up to Month 13 for those 2 groups.

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) Any pIMDs, from Day 0 up to Month 13	2 Participants	2 Participants	2 Participants
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) Any pIMDs, from Day 0 up to Month 18	—	—	2 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 36 (throughout the study period)

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.

MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Medically Significant Conditions (MSCs)	134 Participants	153 Participants	87 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 36 (throughout the study period)

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) Any SAEs	20 Participants	28 Participants	24 Participants
Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants	1 Participants
Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) Fatal SAEs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 36 (throughout the study period)

Population: The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.

Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=1 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=34 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=1 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies Ectopic pregnancy	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies Elective termination NO ACA	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies Live Infant NO ACA	1 Participants	30 Participants	1 Participants
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies Stillbirth NO ACA	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Month 13

Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.

The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.

Outcome measures

Outcome measures
Measure	Cervarix 1 Group n=550 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 Participants Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 Participants Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Number of Subjects Completing the Vaccination Course	550 Participants	482 Participants	415 Participants

Adverse Events

Cervarix 1 Group

Serious events: 20 serious events

Other events: 513 other events

Deaths: 0 deaths

Cervarix 2 Group

Serious events: 28 serious events

Other events: 466 other events

Deaths: 0 deaths

Cervarix 3 Group

Serious events: 24 serious events

Other events: 387 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Cervarix 1 Group n=550 participants at risk Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 2 Group n=482 participants at risk Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.	Cervarix 3 Group n=415 participants at risk Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
Infections and infestations Nasopharyngitis	4.0% 22/550 • Number of events 22 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.6% 27/482 • Number of events 27 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	3.4% 14/415 • Number of events 14 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Pain	90.7% 499/550 • Number of events 499 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	96.0% 461/480 • Number of events 461 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	92.3% 381/413 • Number of events 381 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Redness	44.9% 247/550 • Number of events 247 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	44.2% 212/480 • Number of events 212 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	47.7% 197/413 • Number of events 197 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Swelling	40.9% 225/550 • Number of events 225 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	42.5% 204/480 • Number of events 204 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	41.4% 171/413 • Number of events 171 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Arthralgia	20.2% 111/550 • Number of events 111 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	22.3% 107/480 • Number of events 107 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	22.5% 93/413 • Number of events 93 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Fatigue	44.9% 247/550 • Number of events 247 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	64.6% 310/480 • Number of events 310 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	52.1% 215/413 • Number of events 215 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Gastrointestinal symptoms	17.8% 98/550 • Number of events 98 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	27.9% 134/480 • Number of events 134 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	18.6% 77/413 • Number of events 77 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Headache	37.1% 204/550 • Number of events 204 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	51.2% 246/480 • Number of events 246 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	44.8% 185/413 • Number of events 185 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Myalgia	50.5% 278/550 • Number of events 278 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	61.5% 295/480 • Number of events 295 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	53.5% 221/413 • Number of events 221 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Rash	6.0% 33/550 • Number of events 33 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.2% 25/480 • Number of events 25 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	7.0% 29/413 • Number of events 29 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Fever	7.5% 41/550 • Number of events 41 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	10.0% 48/480 • Number of events 48 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	10.2% 42/413 • Number of events 42 • Solicited symptoms were collected during the 7-day period (Days 0-6) after vaccination.Unsolicited AEs were collected during the 30-day period (Days 0-29) after vaccination. SAEs were collected from Day 0 to Month 36. The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Additional Information

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