Trial Outcomes & Findings for Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. (NCT NCT00250276)

NCT ID: NCT00250276

Last Updated: 2020-01-02

Results Overview

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 798 participants
• Primary outcome timeframe: At Month 7
• Results posted on: 2020-01-02

Participant Flow

Participant milestones

Measure	Cervarix Lot1 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Study STARTED	199	198	201	200
Overall Study COMPLETED	182	177	182	181
Overall Study NOT COMPLETED	17	21	19	19

Reasons for withdrawal

Measure	Cervarix Lot1 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Overall Study Serious Adverse Event	0	0	1	0
Overall Study Non-serious Adverse Event	2	0	0	2
Overall Study Protocol Violation	0	1	0	0
Overall Study Withdrawal by Subject	1	2	3	2
Overall Study Migrated/moved from study area	3	0	2	7
Overall Study Lost to Follow-up	11	18	13	8

Baseline Characteristics

Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

Baseline characteristics by cohort

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Total n=798 Participants Total of all reporting groups
Age, Continuous	21.8 Years STANDARD_DEVIATION 2.08 • n=5 Participants	21.8 Years STANDARD_DEVIATION 2.08 • n=7 Participants	21.9 Years STANDARD_DEVIATION 2.00 • n=5 Participants	22.0 Years STANDARD_DEVIATION 1.96 • n=4 Participants	21.88 Years STANDARD_DEVIATION 2.03 • n=21 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	198 Participants n=7 Participants	201 Participants n=5 Participants	200 Participants n=4 Participants	798 Participants n=21 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	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥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.

Outcome measures

Measure	Cervarix Lot1 Group n=129 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=143 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=135 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=407 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=117 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) Anti-HPV-16	118 Participants	127 Participants	126 Participants	371 Participants	102 Participants
Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) Anti-HPV-18	129 Participants	143 Participants	135 Participants	407 Participants	117 Participants

PRIMARY outcome

Timeframe: At Month 7

Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.

Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.

Outcome measures

Measure	Cervarix Lot1 Group n=54 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=38 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=43 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=57 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-16	54 Participants	38 Participants	43 Participants	57 Participants	—
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-18	43 Participants	22 Participants	34 Participants	41 Participants	—

SECONDARY outcome

Timeframe: At Month 2

Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.

Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.

Outcome measures

Measure	Cervarix Lot1 Group n=128 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=142 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=134 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=116 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-16	117 Participants	126 Participants	125 Participants	102 Participants	—
Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-18	128 Participants	142 Participants	134 Participants	116 Participants	—

SECONDARY outcome

Timeframe: At Month 2

Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.

Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .

Outcome measures

Measure	Cervarix Lot1 Group n=54 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=38 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=43 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=56 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-16	54 Participants	38 Participants	43 Participants	56 Participants	—
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 Anti-HPV-18	43 Participants	22 Participants	34 Participants	41 Participants	—

SECONDARY outcome

Timeframe: During the 7-days (Day 0-6) post-vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.

Outcome measures

Measure	Cervarix Lot1 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=197 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=594 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=197 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain Dose 2	167 Participants	166 Participants	170 Participants	503 Participants	161 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling Across	15 Participants	6 Participants	6 Participants	27 Participants	10 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain Dose 1	188 Participants	190 Participants	178 Participants	556 Participants	185 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain Dose 1	20 Participants	16 Participants	17 Participants	53 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness Dose 1	74 Participants	71 Participants	77 Participants	222 Participants	75 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling Dose 1	58 Participants	57 Participants	57 Participants	172 Participants	54 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling Dose 1	9 Participants	2 Participants	2 Participants	13 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain Dose 2	17 Participants	10 Participants	19 Participants	46 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness Dose 2	78 Participants	85 Participants	79 Participants	242 Participants	62 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness Dose 2	3 Participants	6 Participants	0 Participants	9 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling Dose 2	64 Participants	59 Participants	56 Participants	179 Participants	53 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling Dose 2	7 Participants	2 Participants	2 Participants	11 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain Dose 3	164 Participants	151 Participants	162 Participants	477 Participants	156 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain Dose 3	21 Participants	14 Participants	11 Participants	46 Participants	15 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness Dose 3	94 Participants	102 Participants	96 Participants	292 Participants	92 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness Dose 3	5 Participants	6 Participants	4 Participants	15 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling Dose 3	92 Participants	84 Participants	85 Participants	261 Participants	82 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling Dose 3	8 Participants	3 Participants	2 Participants	13 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain Across	194 Participants	192 Participants	190 Participants	576 Participants	192 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain Across	45 Participants	29 Participants	34 Participants	108 Participants	30 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness Across	118 Participants	128 Participants	127 Participants	373 Participants	126 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness Across	8 Participants	9 Participants	4 Participants	21 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling Across	116 Participants	112 Participants	113 Participants	341 Participants	107 Participants

SECONDARY outcome

Timeframe: During the 7-days (Day 0-6) post-vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.

Outcome measures

Measure	Cervarix Lot1 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=197 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=594 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=196 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia	36 Participants	44 Participants	41 Participants	121 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	4 Participants	4 Participants	6 Participants	14 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	69 Participants	70 Participants	60 Participants	199 Participants	65 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	19 Participants	19 Participants	13 Participants	51 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	1 Participants	0 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	14 Participants	17 Participants	8 Participants	39 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	81 Participants	84 Participants	73 Participants	238 Participants	80 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	4 Participants	1 Participants	4 Participants	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	60 Participants	62 Participants	48 Participants	170 Participants	61 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	4 Participants	7 Participants	4 Participants	15 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	1 Participants	5 Participants	3 Participants	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastro-intestinal	32 Participants	39 Participants	34 Participants	105 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastro-intestinal	1 Participants	2 Participants	0 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastro-intestinal	17 Participants	24 Participants	19 Participants	60 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	8 Participants	4 Participants	2 Participants	14 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	44 Participants	49 Participants	38 Participants	131 Participants	46 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia	45 Participants	55 Participants	50 Participants	150 Participants	42 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia	3 Participants	2 Participants	3 Participants	8 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	2 Participants	3 Participants	4 Participants	9 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria	5 Participants	3 Participants	3 Participants	11 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria	2 Participants	2 Participants	2 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: During the 7-days (Day 0-6) post-vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.

Outcome measures

Measure	Cervarix Lot1 Group n=195 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=195 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=588 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=193 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	27 Participants	33 Participants	29 Participants	89 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria	0 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	14 Participants	14 Participants	14 Participants	42 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	12 Participants	11 Participants	10 Participants	33 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	63 Participants	73 Participants	69 Participants	205 Participants	58 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	2 Participants	4 Participants	3 Participants	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	39 Participants	55 Participants	38 Participants	132 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	7 Participants	5 Participants	7 Participants	19 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	5 Participants	2 Participants	2 Participants	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastro-intestinal	22 Participants	21 Participants	28 Participants	71 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastro-intestinal	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastro-intestinal	14 Participants	14 Participants	12 Participants	40 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	47 Participants	51 Participants	46 Participants	144 Participants	41 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	2 Participants	4 Participants	2 Participants	8 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia	30 Participants	37 Participants	39 Participants	106 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia	0 Participants	1 Participants	3 Participants	4 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia	22 Participants	30 Participants	31 Participants	83 Participants	21 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	1 Participants	3 Participants	8 Participants	12 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	1 Participants	3 Participants	5 Participants	9 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria	2 Participants	2 Participants	2 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: During the 7-days (Day 0-6) post-vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.

Outcome measures

Measure	Cervarix Lot1 Group n=181 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=178 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=184 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=543 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=181 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	9 Participants	1 Participants	2 Participants	12 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	18 Participants	19 Participants	18 Participants	55 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	15 Participants	16 Participants	12 Participants	43 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	76 Participants	67 Participants	64 Participants	207 Participants	60 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	58 Participants	50 Participants	49 Participants	157 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	7 Participants	6 Participants	4 Participants	17 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	1 Participants	4 Participants	1 Participants	6 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastro-intestinal	17 Participants	19 Participants	25 Participants	61 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastro-intestinal	2 Participants	1 Participants	1 Participants	4 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastro-intestinal	8 Participants	9 Participants	14 Participants	31 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	53 Participants	44 Participants	49 Participants	146 Participants	39 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	5 Participants	2 Participants	4 Participants	11 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	34 Participants	31 Participants	29 Participants	94 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia	44 Participants	38 Participants	39 Participants	121 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia	3 Participants	2 Participants	1 Participants	6 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia	35 Participants	35 Participants	32 Participants	102 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	7 Participants	4 Participants	9 Participants	20 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	5 Participants	2 Participants	6 Participants	13 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria	3 Participants	0 Participants	5 Participants	8 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria	1 Participants	0 Participants	2 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: During the 7-days (Day 0-6) post-vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.

Outcome measures

Measure	Cervarix Lot1 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=197 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=594 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=197 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	13 Participants	6 Participants	8 Participants	27 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia	38 Participants	40 Participants	32 Participants	110 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia	2 Participants	1 Participants	2 Participants	5 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia	31 Participants	32 Participants	22 Participants	85 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	117 Participants	117 Participants	106 Participants	340 Participants	105 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	90 Participants	95 Participants	78 Participants	263 Participants	90 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	16 Participants	18 Participants	14 Participants	48 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	6 Participants	11 Participants	5 Participants	22 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastro-intestinal	55 Participants	61 Participants	57 Participants	173 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastro-intestinal	4 Participants	3 Participants	2 Participants	9 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastro-intestinal	32 Participants	38 Participants	33 Participants	103 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	99 Participants	103 Participants	95 Participants	297 Participants	93 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	14 Participants	9 Participants	8 Participants	31 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	68 Participants	77 Participants	57 Participants	202 Participants	68 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia	75 Participants	82 Participants	73 Participants	230 Participants	66 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia	6 Participants	5 Participants	6 Participants	17 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia	62 Participants	70 Participants	62 Participants	194 Participants	48 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Rash	11 Participants	10 Participants	19 Participants	40 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Rash	7 Participants	7 Participants	13 Participants	27 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Urticaria	7 Participants	5 Participants	7 Participants	19 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Urticaria	3 Participants	3 Participants	4 Participants	10 Participants	8 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 7

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With New Onset Chronic Diseases (NOCDs)	3 Participants	4 Participants	7 Participants	14 Participants	3 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 7

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

MSAEs 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

Measure	Cervarix Lot1 Group n=598 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Medically Significant Adverse Events (MSAEs)	71 Participants	23 Participants	—	—	—

SECONDARY outcome

Timeframe: From Month 0 to Month 12

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Outcome measures

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With (NOCDs)	4 Participants	4 Participants	7 Participants	15 Participants	3 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 12

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

MSAEs 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

Measure	Cervarix Lot1 Group n=598 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With MSAEs	78 Participants	23 Participants	—	—	—

SECONDARY outcome

Timeframe: Within 30 days (Day 0-29) post vaccination

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.

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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any (AEs)	58 Participants	56 Participants	76 Participants	190 Participants	67 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 (AEs)	5 Participants	6 Participants	14 Participants	25 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related (AEs)	22 Participants	23 Participants	30 Participants	75 Participants	32 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 7

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	0 Participants	2 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: From Month 0 to Month 12

Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Cervarix Lot1 Group n=199 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 Participants The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 Participants Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	6 Participants	1 Participants	2 Participants	9 Participants	3 Participants

Adverse Events

Cervarix Lot1 Group

Serious events: 6 serious events

Other events: 196 other events

Deaths: 0 deaths

Cervarix Lot2 Group

Serious events: 1 serious events

Other events: 194 other events

Deaths: 0 deaths

Cervarix Lot3 Group

Serious events: 2 serious events

Other events: 191 other events

Deaths: 0 deaths

Pooled Group

Serious events: 9 serious events

Other events: 581 other events

Deaths: 0 deaths

Cervarix Low Group

Serious events: 3 serious events

Other events: 194 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cervarix Lot1 Group n=199 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 participants at risk The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
Cardiac disorders Supraventricular tachycardia	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.50% 1/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Endocrine disorders Basedow's disease	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Infections and infestations Appendicitis	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	1.0% 2/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Infections and infestations Cerebral malaria	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Infections and infestations Pelvic inflammatory disease	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Infections and infestations Tuberculosis	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Injury, poisoning and procedural complications Femur fracture	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.50% 1/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.50% 1/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Nervous system disorders Syncope	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.50% 1/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.51% 1/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.50% 1/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.17% 1/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	0.00% 0/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).

Other adverse events

Measure	Cervarix Lot1 Group n=199 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot2 Group n=198 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Cervarix Lot3 Group n=201 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.	Pooled Group n=598 participants at risk The 3 study groups receiving the 3 different lots of Cervarix™ vaccine manufactured at 600L scale were pooled to demonstrate consistency for data analysis.	Cervarix Low Group n=200 participants at risk Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm.
General disorders Pain	98.0% 194/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	97.5% 192/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	95.5% 190/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	97.0% 576/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	97.5% 192/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Redness	59.6% 118/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	65.0% 128/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	63.8% 127/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	62.8% 373/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	64.0% 126/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Swelling	58.6% 116/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	56.9% 112/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	56.8% 113/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	57.4% 341/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	54.3% 107/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Arthralgia	19.2% 38/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	20.3% 40/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	16.1% 32/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	18.5% 110/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	17.8% 35/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Fatigue	59.1% 117/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	59.4% 117/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	53.3% 106/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	57.2% 340/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	53.3% 105/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Fever/(Axillary) (°C)	8.1% 16/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	9.1% 18/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	7.0% 14/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	8.1% 48/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	7.6% 15/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Gastrointestinal	27.8% 55/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	31.0% 61/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	28.6% 57/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	29.1% 173/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	24.9% 49/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Headache	50.0% 99/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	52.3% 103/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	47.7% 95/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	50.0% 297/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	47.2% 93/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Myalgia	37.9% 75/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	41.6% 82/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	36.7% 73/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	38.7% 230/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	33.5% 66/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Rash	5.6% 11/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	5.1% 10/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	9.5% 19/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	6.7% 40/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	7.6% 15/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Urticaria	3.5% 7/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	2.5% 5/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	3.5% 7/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	3.2% 19/594 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	5.1% 10/197 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
General disorders Injection site pruritus	3.5% 7/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	1.5% 3/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	2.0% 4/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	2.3% 14/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	5.0% 10/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).
Infections and infestations Nasopharyngitis	4.0% 8/199 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	4.0% 8/198 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	5.0% 10/201 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	4.3% 26/598 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).	3.5% 7/200 • Solicited local/general symptoms: during the 7-days (Day 0-6) post vaccination. AEs: during the 30-days (Day 0-29) post vaccination. SAEs throughout the whole study period (up to Month 12).

Additional Information

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Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER