Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults (NCT NCT01755689)

Last Updated: 2018-07-03

Results Overview

The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1300 participants

Primary outcome timeframe

At one month after vaccination with Nimenrix (Month 1)

Results posted on

2018-07-03

Participant Flow

Participant milestones

Participant milestones
Measure	Nimenrix+Cervarix (1,2,7-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Cervarix Group Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Study STARTED	259	259	261	260	261
Overall Study COMPLETED	256	254	255	254	255
Overall Study NOT COMPLETED	3	5	6	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix+Cervarix (1,2,7-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Cervarix Group Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Overall Study Withdrawal by Subject	1	3	2	1	1
Overall Study Migrated/moved from study area	0	1	1	1	1
Overall Study Lost to Follow-up	1	0	1	0	2
Overall Study Pregnancy	1	1	2	4	2

Baseline Characteristics

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Cervarix Group n=261 Participants Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=260 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Total n=1300 Participants Total of all reporting groups
Age, Continuous	16.3 Participants STANDARD_DEVIATION 4.6 • n=5 Participants	16.6 Participants STANDARD_DEVIATION 4.4 • n=7 Participants	16.6 Participants STANDARD_DEVIATION 4.6 • n=5 Participants	16.6 Participants STANDARD_DEVIATION 4.6 • n=4 Participants	16.6 Participants STANDARD_DEVIATION 4.5 • n=21 Participants	16.5 Participants STANDARD_DEVIATION 4.5 • n=8 Participants
Sex: Female, Male Female	259 Participants n=5 Participants	259 Participants n=7 Participants	261 Participants n=5 Participants	260 Participants n=4 Participants	261 Participants n=21 Participants	1300 Participants n=8 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	0 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage / African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian Heritage	86 Participants n=5 Participants	86 Participants n=7 Participants	86 Participants n=5 Participants	86 Participants n=4 Participants	86 Participants n=21 Participants	430 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European Heritage	87 Participants n=5 Participants	86 Participants n=7 Participants	87 Participants n=5 Participants	87 Participants n=4 Participants	88 Participants n=21 Participants	435 Participants n=8 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	86 Participants n=5 Participants	87 Participants n=7 Participants	88 Participants n=5 Participants	86 Participants n=4 Participants	87 Participants n=21 Participants	434 Participants n=8 Participants

PRIMARY outcome

Timeframe: At one month after vaccination with Nimenrix (Month 1)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=255 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=257 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenA	5517.1 Titers Interval 4791.4 to 6352.6	5523.5 Titers Interval 4913.2 to 6209.6	4649.6 Titers Interval 4022.8 to 5374.0	—	—
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenC	4277.3 Titers Interval 3604.3 to 5076.1	5091.0 Titers Interval 4338.6 to 5973.8	3598.6 Titers Interval 3004.2 to 4310.7	—	—
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenW-135	14782.1 Titers Interval 12254.2 to 17831.5	18068.3 Titers Interval 15381.6 to 21224.4	11663.6 Titers Interval 9336.8 to 14570.2	—	—
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) rSBA-MenY	11871.0 Titers Interval 10542.3 to 13367.2	12758.9 Titers Interval 11569.6 to 14070.5	11201.2 Titers Interval 9678.7 to 12963.1	—	—

PRIMARY outcome

Timeframe: At one month after vaccination with Cervarix (Month 7)

Population: The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=248 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=249 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=244 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=247 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-16	12124.9 EU/mL Interval 10564.5 to 13915.7	11672.1 EU/mL Interval 10173.5 to 13391.4	9563.8 EU/mL Interval 8262.0 to 11070.7	11470.7 EU/mL Interval 10018.5 to 13133.5	—
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-18	5234.1 EU/mL Interval 4573.9 to 5989.6	5655.0 EU/mL Interval 4978.5 to 6423.4	4306.2 EU/mL Interval 3748.3 to 4947.1	5110.0 EU/mL Interval 4487.0 to 5819.6	—

PRIMARY outcome

Timeframe: At one month after Boostrix vaccination (Month 1)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=250 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL Anti-D	235 Participants	248 Participants	—	—	—
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL Anti-T	249 Participants	256 Participants	—	—	—

PRIMARY outcome

Timeframe: At one month after Boostrix vaccination (Month 1)

The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=247 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	52.9 IU/mL Interval 46.4 to 60.4	73.2 IU/mL Interval 65.0 to 82.5	—	—	—
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	278.7 IU/mL Interval 249.5 to 311.2	472.4 IU/mL Interval 419.7 to 531.8	—	—	—
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	193.4 IU/mL Interval 159.0 to 235.1	318.6 IU/mL Interval 262.4 to 386.8	—	—	—

SECONDARY outcome

Timeframe: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)

The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=255 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=257 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenA ≥1:8, Month 0	112 Participants	118 Participants	129 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenC ≥1:8, Month 0	34 Participants	29 Participants	40 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenW-135 ≥1:8, Month 0	23 Participants	24 Participants	22 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenY ≥1:8, Month 0	86 Participants	102 Participants	80 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenA ≥1:128, Month 0	78 Participants	86 Participants	82 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenC ≥1:128, Month 0	20 Participants	10 Participants	23 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenW-135 ≥1:128, Month 0	22 Participants	23 Participants	20 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenY ≥1:128, Month 0	84 Participants	99 Participants	74 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenA ≥1:8, Month 1	255 Participants	255 Participants	255 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenC ≥1:8, Month 1	254 Participants	253 Participants	253 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenW-135 ≥1:8, Month 1	253 Participants	255 Participants	250 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenY ≥1:8, Month 1	256 Participants	255 Participants	255 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenA ≥1:128, Month 1	255 Participants	255 Participants	255 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenC ≥1:128, Month 1	254 Participants	252 Participants	252 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenW-135 ≥1:128, Month 1	253 Participants	255 Participants	250 Participants	—	—
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 rSBA-MenY ≥1:128, Month 1	256 Participants	255 Participants	255 Participants	—	—

SECONDARY outcome

Timeframe: At one month after Nimenrix vaccination (Month 1)

rSBA vaccine response for serogroups A, C, W-135 and Y was defined as: * For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination. * For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=255 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=256 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response rSBA-MenA	240 Participants	235 Participants	230 Participants	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response rSBA-MenC	250 Participants	251 Participants	246 Participants	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response rSBA-MenW-135	252 Participants	255 Participants	248 Participants	—	—
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response rSBA-MenY	245 Participants	253 Participants	251 Participants	—	—

SECONDARY outcome

Timeframe: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.

The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=255 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL Anti-T ≥ 0.1 IU/mL, Month 0	236 Participants	—	—	—	—
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL Anti-T ≥ 0.1 IU/mL, Month 1	255 Participants	—	—	—	—
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL Anti-T ≥ 1 IU/mL, Month 0	151 Participants	—	—	—	—
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL Anti-T ≥ 1 IU/mL, Month 1	253 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)

Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=255 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-T Antibody Concentrations Anti-T, Month 0	1.2 IU/mL Interval 1.0 to 1.4	—	—	—	—
Anti-T Antibody Concentrations Anti-T, Month 1	25.4 IU/mL Interval 22.8 to 28.3	—	—	—	—

SECONDARY outcome

Timeframe: Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=246 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=248 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=249 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=244 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=247 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL Anti-HPV-18, Month 0	11 Participants	12 Participants	17 Participants	14 Participants	14 Participants
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL Anti-HPV-16, Month 7/Month 8	245 Participants	248 Participants	249 Participants	244 Participants	247 Participants
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL Anti-HPV-16, Month 0	17 Participants	29 Participants	32 Participants	29 Participants	22 Participants
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL Anti-HPV-18, Month 7/Month 8	245 Participants	248 Participants	249 Participants	244 Participants	247 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)

Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=235 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=236 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=232 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=230 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=233 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-16, Month 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-16, Month 7/Month 8	228 Participants	219 Participants	217 Participants	215 Participants	225 Participants
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-18, Month 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-18, Month 7/Month 8	234 Participants	236 Participants	232 Participants	230 Participants	233 Participants

SECONDARY outcome

Timeframe: Prior to and one month after the third dose of Cervarix (Months 0 and 8)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group.

The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=246 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-16, Month 8	11128.2 EU/mL Interval 9471.8 to 13074.4	—	—	—	—
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-16, Month 0	10.9 EU/mL Interval 10.2 to 11.6	—	—	—	—
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-18, Month 0	9.8 EU/mL Interval 9.3 to 10.4	—	—	—	—
Anti-HPV-16 and Anti-HPV-18 Concentrations Anti-HPV-18, Month 8	5357.0 EU/mL Interval 4550.2 to 6306.9	—	—	—	—

SECONDARY outcome

Timeframe: At one month after Boostrix vaccination (Month 1)

Booster responses to the PT, FHA and PRN antigens were defined as: * For initially seronegative subjects (antibody concentrations: \< 2.046 IU/ml for anti-FHA, \< 2.187 IU/ml for anti-PRN, \< 2.693 IU/ml for anti-PT), antibody concentration ≥ 4\*cut\_off IU/ml at Month 1 post-vaccination; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration \< 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=247 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PT	218 Participants	235 Participants	—	—	—
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-FHA	240 Participants	247 Participants	—	—	—
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies Anti-PRN	231 Participants	248 Participants	—	—	—

SECONDARY outcome

Timeframe: Prior to and one month after Boostrix vaccination (Month 0 and Month 1)

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=251 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-D, Month 0	214 Participants	223 Participants	—	—	—
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-D, Month 1	250 Participants	256 Participants	—	—	—
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-T, Month 0	239 Participants	248 Participants	—	—	—
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL Anti-T, Month 1	250 Participants	256 Participants	—	—	—

SECONDARY outcome

Timeframe: Prior to and one month after Boostrix vaccination (Months 0 and 1)

The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=251 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 0	0.5 IU/mL Interval 0.4 to 0.5	0.5 IU/mL Interval 0.4 to 0.6	—	—	—
Anti-D and Anti-T Antibody Concentrations Anti-D, Month 1	4.7 IU/mL Interval 4.2 to 5.2	6.6 IU/mL Interval 5.9 to 7.4	—	—	—
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 0	1.3 IU/mL Interval 1.1 to 1.5	1.3 IU/mL Interval 1.1 to 1.5	—	—	—
Anti-D and Anti-T Antibody Concentrations Anti-T, Month 1	25.9 IU/mL Interval 23.4 to 28.8	15.4 IU/mL Interval 14.1 to 16.9	—	—	—

SECONDARY outcome

Timeframe: Prior to and one month after Boostrix vaccination (Months 0 and 1)

The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=251 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=256 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-PT, Month 0	156 Participants	153 Participants	—	—	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-PT, Month 1	240 Participants	252 Participants	—	—	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-FHA, Month 0	235 Participants	244 Participants	—	—	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-FHA, Month 1	247 Participants	256 Participants	—	—	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-PRN, Month 0	218 Participants	229 Participants	—	—	—
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value Anti-PRN, Month 1	246 Participants	256 Participants	—	—	—

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=257 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=259 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Nimenrix), Dose 1	1 Participants	1 Participants	—	5 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Cervarix), Across doses	43 Participants	56 Participants	54 Participants	62 Participants	48 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Nimenrix), Dose 1	152 Participants	140 Participants	—	156 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Nimenrix), Dose 1	4 Participants	3 Participants	—	7 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Boostrix), Dose 1	—	—	—	189 Participants	200 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Boostrix), Dose 1	—	—	—	21 Participants	15 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Cervarix), Dose 1	—	213 Participants	205 Participants	217 Participants	221 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Cervarix), Dose 1	—	8 Participants	11 Participants	23 Participants	18 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Nimenrix), Dose 1	57 Participants	42 Participants	—	54 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Nimenrix), Dose 1	4 Participants	2 Participants	—	0 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Boostrix), Dose 1	—	—	—	73 Participants	53 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Boostrix), Dose 1	—	—	—	2 Participants	4 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Cervarix), Dose 1	—	56 Participants	54 Participants	62 Participants	48 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Cervarix), Dose 1	—	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Nimenrix), Dose 1	40 Participants	34 Participants	—	58 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Boostrix), Dose 1	—	—	—	79 Participants	58 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Boostrix), Dose 1	—	—	—	5 Participants	7 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Nimenrix), Across doses	1 Participants	1 Participants	—	5 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Cervarix), Dose 1	—	42 Participants	37 Participants	64 Participants	55 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Cervarix), Dose 1	—	1 Participants	1 Participants	1 Participants	5 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Cervarix), Dose 2	193 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Cervarix), Dose 2	15 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Cervarix), Dose 2	43 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Cervarix), Dose 2	0 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Cervarix), Dose 2	41 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Cervarix), Dose 2	1 Participants	—	—	—	—
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Nimenrix), Across doses	152 Participants	140 Participants	—	156 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Nimenrix), Across doses	4 Participants	3 Participants	—	7 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Boostrix), Across doses	—	—	—	189 Participants	200 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Boostrix), Across doses	—	—	—	21 Participants	15 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Pain (Cervarix), Across doses	193 Participants	213 Participants	205 Participants	217 Participants	221 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain (Cervarix), Across doses	15 Participants	8 Participants	11 Participants	23 Participants	18 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Nimenrix), Across doses	57 Participants	42 Participants	—	54 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Nimenrix), Across doses	4 Participants	2 Participants	—	0 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Redness (Boostrix), Across doses	—	—	—	73 Participants	53 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Boostrix), Across doses	—	—	—	2 Participants	4 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness (Cervarix), Across doses	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Nimenrix), Across doses	40 Participants	34 Participants	—	58 Participants	—
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Boostrix), Across doses	—	—	—	79 Participants	58 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Boostrix), Across doses	—	—	—	5 Participants	7 Participants
Number of Subjects Reporting Solicited Local Symptoms Any Swelling (Cervarix), Across doses	41 Participants	42 Participants	37 Participants	64 Participants	55 Participants
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling (Cervarix), Across doses	1 Participants	1 Participants	1 Participants	1 Participants	5 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for "Dose 2" because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=257 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=259 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects Reporting Solicited General Symptoms Related Fatigue, Dose 1	82 Participants	92 Participants	79 Participants	103 Participants	99 Participants
Number of Subjects Reporting Solicited General Symptoms Any Gastrointestinal, Dose 1	21 Participants	27 Participants	23 Participants	29 Participants	22 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Gastrointestinal, Dose 1	19 Participants	27 Participants	21 Participants	26 Participants	20 Participants
Number of Subjects Reporting Solicited General Symptoms Any Headache, Dose 1	82 Participants	94 Participants	78 Participants	99 Participants	95 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Headache, Dose 1	5 Participants	3 Participants	5 Participants	5 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Related Headache, Dose 1	81 Participants	89 Participants	73 Participants	92 Participants	85 Participants
Number of Subjects Reporting Solicited General Symptoms Any Myalgia, Dose 1	65 Participants	83 Participants	85 Participants	96 Participants	101 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Myalgia, Dose 1	0 Participants	4 Participants	6 Participants	9 Participants	9 Participants
Number of Subjects Reporting Solicited General Symptoms Related Myalgia, Dose 1	60 Participants	81 Participants	82 Participants	92 Participants	100 Participants
Number of Subjects Reporting Solicited General Symptoms Any Rash, Dose 1	4 Participants	8 Participants	8 Participants	6 Participants	6 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Rash, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Rash, Dose 1	1 Participants	6 Participants	7 Participants	6 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Any Fever, Dose 1	24 Participants	32 Participants	15 Participants	38 Participants	27 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Fever, Dose 1	21 Participants	31 Participants	14 Participants	37 Participants	25 Participants
Number of Subjects Reporting Solicited General Symptoms Any Urticaria, Dose 1	0 Participants	4 Participants	4 Participants	5 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Urticaria, Dose 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Urticaria, Dose 1	0 Participants	3 Participants	4 Participants	5 Participants	3 Participants
Number of Subjects Reporting Solicited General Symptoms Related Fatigue, Dose 2	58 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	1 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Myalgia, Dose 2	72 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Arthralgia, Across doses	34 Participants	18 Participants	13 Participants	36 Participants	23 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Arthralgia, Across doses	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Related Arthralgia, Across doses	34 Participants	18 Participants	13 Participants	34 Participants	23 Participants
Number of Subjects Reporting Solicited General Symptoms Any Fatigue, Across doses	105 Participants	95 Participants	85 Participants	110 Participants	101 Participants
Number of Subjects Reporting Solicited General Symptoms Any Rash, Across doses	7 Participants	8 Participants	8 Participants	6 Participants	6 Participants
Number of Subjects Reporting Solicited General Symptoms Any Arthralgia, Dose 2	18 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Arthralgia, Dose 2	0 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Arthralgia, Dose 2	18 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Fatigue, Dose 2	61 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fatigue, Dose 2	2 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Gastrointestinal, Dose 2	10 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Gastrointestinal, Dose 2	8 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Headache, Dose 2	58 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Headache, Dose 2	3 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Headache, Dose 2	55 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Myalgia, Dose 2	73 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Myalgia, Dose 2	4 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Rash, Dose 2	3 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Rash, Dose 2	0 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Rash, Dose 2	3 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Urticaria, Dose 2	2 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Any Fever, Dose 2	11 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Fever, Dose 2	10 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Urticaria, Dose 2	0 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Related Urticaria, Dose 2	2 Participants	—	—	—	—
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fatigue, Across doses	4 Participants	4 Participants	2 Participants	8 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Related Fatigue, Across doses	98 Participants	92 Participants	79 Participants	103 Participants	99 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Rash, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Any Gastrointestinal, Across doses	26 Participants	27 Participants	23 Participants	29 Participants	22 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Gastrointestinal, Across doses	23 Participants	27 Participants	21 Participants	26 Participants	20 Participants
Number of Subjects Reporting Solicited General Symptoms Any Headache, Across doses	101 Participants	94 Participants	78 Participants	99 Participants	95 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Headache, Across doses	8 Participants	3 Participants	5 Participants	5 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Related Headache, Across doses	99 Participants	89 Participants	73 Participants	92 Participants	85 Participants
Number of Subjects Reporting Solicited General Symptoms Any Myalgia, Across doses	95 Participants	83 Participants	85 Participants	96 Participants	101 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Myalgia, Across doses	4 Participants	4 Participants	6 Participants	9 Participants	9 Participants
Number of Subjects Reporting Solicited General Symptoms Related Myalgia, Across doses	91 Participants	81 Participants	82 Participants	92 Participants	100 Participants
Number of Subjects Reporting Solicited General Symptoms Related Rash, Across doses	4 Participants	6 Participants	7 Participants	6 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Any Fever, Across doses	34 Participants	32 Participants	15 Participants	38 Participants	27 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fever, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Fever, Across doses	30 Participants	31 Participants	14 Participants	37 Participants	25 Participants
Number of Subjects Reporting Solicited General Symptoms Any Urticaria, Across doses	2 Participants	4 Participants	4 Participants	5 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Any Arthralgia, Dose 1	23 Participants	18 Participants	13 Participants	36 Participants	23 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Arthralgia, Dose 1	0 Participants	1 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Related Arthralgia, Dose 1	23 Participants	18 Participants	13 Participants	34 Participants	23 Participants
Number of Subjects Reporting Solicited General Symptoms Any Fatigue, Dose 1	87 Participants	95 Participants	85 Participants	110 Participants	101 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	4 Participants	2 Participants	8 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Grade 3 Urticaria, Across doses	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Related Urticaria, Across doses	2 Participants	3 Participants	4 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with 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

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=261 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Unsolicited Adverse Events AE(s)	37 Participants	35 Participants	35 Participants	42 Participants	39 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 8)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

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

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=261 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Serious Adverse Events SAE(s)	3 Participants	2 Participants	5 Participants	7 Participants	6 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 8)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=261 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 8)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 Participants Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=261 Participants Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=260 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 Participants Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Number of Subjects With New Onset Chronic Illnesses (NOCIs)	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants

Adverse Events

Nimenrix+Cervarix (1,2,7-Month) Group

Serious events: 3 serious events

Other events: 232 other events

Deaths: 0 deaths

Nimenrix+Cervarix (0,1,6-Month) Group

Serious events: 2 serious events

Other events: 228 other events

Deaths: 0 deaths

Cervarix Group

Serious events: 5 serious events

Other events: 222 other events

Deaths: 0 deaths

Nimenrix+Cervarix+Boostrix Group

Serious events: 7 serious events

Other events: 236 other events

Deaths: 0 deaths

Boostrix+Cervarix Group

Serious events: 6 serious events

Other events: 243 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 participants at risk Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 participants at risk Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Cervarix Group n=261 participants at risk Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=260 participants at risk Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 participants at risk Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Metabolism and nutrition disorders Underweight	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Pregnancy, puerperium and perinatal conditions Premature baby	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Respiratory, thoracic and mediastinal disorders Neonatal respiratory distress syndrome	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/260 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Appendicitis	0.77% 2/259 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/260 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Dengue fever	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.39% 1/259 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.77% 2/261 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.77% 2/260 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Gastroenteritis	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/260 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Influenza	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Pelvic inflammatory disease	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Infections and infestations Pharyngitis	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.39% 1/259 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Injury, poisoning and procedural complications Stab wound	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/260 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Nervous system disorders Migraine	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/260 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Reproductive system and breast disorders Ovarian cyst	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Reproductive system and breast disorders Pelvic pain	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.38% 1/261 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.39% 1/259 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/259 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/260 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	0.00% 0/261 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).

Other adverse events

Other adverse events
Measure	Nimenrix+Cervarix (1,2,7-Month) Group n=259 participants at risk Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix (0,1,6-Month) Group n=259 participants at risk Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Cervarix Group n=261 participants at risk Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.	Nimenrix+Cervarix+Boostrix Group n=260 participants at risk Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.	Boostrix+Cervarix Group n=261 participants at risk Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
Musculoskeletal and connective tissue disorders Arthralgia	13.1% 34/259 • Number of events 41 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	6.9% 18/259 • Number of events 18 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	5.0% 13/261 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	13.8% 36/260 • Number of events 36 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	8.8% 23/261 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Skin and subcutaneous tissue disorders Erythema	30.1% 78/259 • Number of events 100 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	26.3% 68/259 • Number of events 68 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	20.7% 54/261 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	34.6% 90/260 • Number of events 90 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	24.5% 64/261 • Number of events 64 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
General disorders Fatigue	40.5% 105/259 • Number of events 148 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	36.7% 95/259 • Number of events 95 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	32.6% 85/261 • Number of events 85 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	42.3% 110/260 • Number of events 110 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	38.7% 101/261 • Number of events 101 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Gastrointestinal disorders Gastrointestinal disorder	10.0% 26/259 • Number of events 31 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	10.4% 27/259 • Number of events 27 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	8.8% 23/261 • Number of events 23 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	11.2% 29/260 • Number of events 29 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	8.4% 22/261 • Number of events 22 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Nervous system disorders Headache	39.8% 103/259 • Number of events 147 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	37.8% 98/259 • Number of events 99 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	29.9% 78/261 • Number of events 78 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	39.2% 102/260 • Number of events 107 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	37.5% 98/261 • Number of events 101 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
Musculoskeletal and connective tissue disorders Myalgia	36.7% 95/259 • Number of events 139 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	32.0% 83/259 • Number of events 83 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	32.6% 85/261 • Number of events 85 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	36.9% 96/260 • Number of events 96 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	38.7% 101/261 • Number of events 101 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
General disorders Pain	83.8% 217/259 • Number of events 345 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	84.9% 220/259 • Number of events 220 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	78.5% 205/261 • Number of events 205 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	87.7% 228/260 • Number of events 228 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	89.3% 233/261 • Number of events 233 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
General disorders Pyrexia	13.5% 35/259 • Number of events 36 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	12.7% 33/259 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	6.1% 16/261 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	15.0% 39/260 • Number of events 39 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	10.7% 28/261 • Number of events 28 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).
General disorders Swelling	23.9% 62/259 • Number of events 81 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	20.8% 54/259 • Number of events 54 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	14.2% 37/261 • Number of events 37 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	37.7% 98/260 • Number of events 98 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).	26.8% 70/261 • Number of events 70 • Solicited local and general symptoms: during the 7-day (Days 0-6) period following each vaccination, Unsolicited AEs: during the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the whole study period (from Month 0 up to Month 8).

Additional Information

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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.
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