Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects (NCT NCT00996125)

NCT ID: NCT00996125

Last Updated: 2018-08-17

Results Overview

Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 750 participants
• Primary outcome timeframe: One month after the third dose (at Month 7)
• Results posted on: 2018-08-17

Participant Flow

Participant milestones

Measure	Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Study STARTED	374	376
Overall Study COMPLETED	369	365
Overall Study NOT COMPLETED	5	11

Reasons for withdrawal

Measure	Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	6
Overall Study Withdrawal by Subject	4	3

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

Baseline characteristics by cohort

Measure	Cervarix Group n=374 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Total n=750 Participants Total of all reporting groups
Age, Continuous	13.1 Years STANDARD_DEVIATION 2.44 • n=5 Participants	13.1 Years STANDARD_DEVIATION 2.42 • n=7 Participants	13.1 Years STANDARD_DEVIATION 2.43 • n=5 Participants
Sex: Female, Male Female	374 Participants n=5 Participants	376 Participants n=7 Participants	750 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the third dose (at Month 7)

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.

Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Outcome measures

Measure	Cervarix Group n=362 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=363 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens Anti-HPV-16	18347.1 EL.U/mL Interval 16915.2 to 19900.2	5.0 EL.U/mL Interval 4.7 to 5.3
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens Anti-HPV-18	7960.2 EL.U/mL Interval 7181.3 to 8823.6	4.1 EL.U/mL Interval 3.8 to 4.3

SECONDARY outcome

Timeframe: At Month 7

Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti- HPV-18 antibodies.

Outcome measures

Measure	Cervarix Group n=338 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=344 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-16	326 Participants	8 Participants
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies Anti-HPV-18	336 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 7 days (Days 0 - 6) following each vaccination

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

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).

Outcome measures

Measure	Cervarix Group n=373 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any pain	350 Participants	299 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 pain	38 Participants	16 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any redness	113 Participants	52 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 redness	2 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any swelling	113 Participants	54 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 swelling	13 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 7 days (Days 0 - 6) following each vaccination

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

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Cervarix Group n=373 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any arthralgia	38 Participants	33 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 arthralgia	0 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related arthralgia	25 Participants	23 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any fatigue	137 Participants	126 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 fatigue	2 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related fatigue	106 Participants	98 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any gastrointestinal symptoms	57 Participants	45 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 gastrointestinal symptoms	2 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related gastrointestinal symptoms	21 Participants	31 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any headache	123 Participants	99 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 headache	5 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related headache	80 Participants	70 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any myalgia	110 Participants	93 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 myalgia	1 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related myalgia	96 Participants	83 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any rash	9 Participants	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 rash	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related rash	3 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any fever	86 Participants	74 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 fever	2 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related fever	40 Participants	27 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any urticaria	8 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 urticaria	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related urticaria	7 Participants	1 Participants

SECONDARY outcome

Timeframe: Throughout the study period (from Day 0 up to Month 12)

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

Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.

MSCs were collected regardless of causal relationship to vaccination and intensity.

Outcome measures

Measure	Cervarix Group n=374 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Medically Significant Conditions (MSCs)	14 Participants	11 Participants

SECONDARY outcome

Timeframe: Throughout the study period (from Day 0 up to Month 12)

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

Outcome measures

Measure	Cervarix Group n=374 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Pregnancies and Pregnancy Outcomes	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 days (Days 0 - 29) after any vaccination

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

Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Measure	Cervarix Group n=374 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AEs	139 Participants	125 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AEs	0 Participants	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AEs	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Throughout the study period (from Day 0 up to Month 12)

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

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Cervarix Group n=374 Participants Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 Participants Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	5 Participants	2 Participants
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Participants	0 Participants

Adverse Events

Cervarix Group

Serious events: 5 serious events

Other events: 360 other events

Deaths: 0 deaths

Placebo Group

Serious events: 2 serious events

Other events: 339 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cervarix Group n=374 participants at risk Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 participants at risk Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Gastrointestinal disorders Abdominal adhesions	0.27% 1/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.00% 0/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Reproductive system and breast disorders Adnexa uteri cyst	0.27% 1/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.00% 0/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Infections and infestations Bronchopneumonia	0.27% 1/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.00% 0/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Gastrointestinal disorders Food poisoning	0.27% 1/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.00% 0/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.27% 1/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Blood and lymphatic system disorders Lymphadenopathy	0.27% 1/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.00% 0/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.27% 1/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	0.27% 1/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.

Other adverse events

Measure	Cervarix Group n=374 participants at risk Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.	Placebo Group n=376 participants at risk Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
Infections and infestations Upper respiratory tract infection	27.0% 101/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	22.9% 86/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
Infections and infestations Nasopharyngitis	5.9% 22/374 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	4.8% 18/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Pain	93.8% 350/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	79.5% 299/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Redness	30.3% 113/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	13.8% 52/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Swelling	30.3% 113/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	14.4% 54/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Arthralgia	10.2% 38/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	8.8% 33/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Fatigue	36.7% 137/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	33.5% 126/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Gastrointestinal symptoms	15.3% 57/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	12.0% 45/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Headache	33.0% 123/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	26.3% 99/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Myalgia	29.5% 110/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	24.7% 93/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.
General disorders Fever	23.1% 86/373 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.	19.7% 74/376 • Serious adverse events were assessed from Day 0 up to Month 12. Systematically assessed frequent adverse events (AEs) and non-systematically assessed frequent AEs were assessed during 7 days and 30 days post vaccination period respectively. For the systematically assessed other (non-serious) adverse events, the total participants at risk in Cervarix Group included those from Total Vaccinated cohort who had the symptom sheet completed and with at least one documented dose.

Additional Information

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Results disclosure agreements

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

Restriction type: OTHER