Trial Outcomes & Findings for A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards. (NCT NCT00730847)

Last Updated: 2019-11-05

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

743 participants

Primary outcome timeframe

During the 7-day follow-up period (Days 0-6) after each dose and across doses

Results posted on

2019-11-05

Participant Flow

Since this was a post-marketing study (PMS), subjects may have received one or two doses of Cervarix outside of the PMS.

Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination. The whole set of data was not cleaned for this study. Analysis was performed on subjects with cleaned data and on subjects with missing data or unresolved data queries, or both. The overall group includes both cleaned and not cleaned data.

Participant milestones

Participant milestones
Measure	Cervarix Group Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Study STARTED	596
Overall Study COMPLETED	465
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix Group Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Overall Study Adverse Event	1
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	16
Overall Study Lost to Follow-up	67
Overall Study Unknown completion status	21
Overall Study Other	24

Baseline Characteristics

A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix Group n=596 Participants Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Age, Continuous	32.8 Years STANDARD_DEVIATION 10.27 • n=5 Participants
Sex: Female, Male Female	596 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized South Asian	594 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	1 Participants n=5 Participants
Race/Ethnicity, Customized Not specified	1 Participants n=5 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.

Outcome measures

Outcome measures
Measure	Cervarix Group n=578 Participants Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	402 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	25 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	116 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	76 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	309 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	16 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	106 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	60 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 3	211 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 3	7 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 3	69 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 3	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 3	47 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 3	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	430 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	38 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	168 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	2 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	119 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	4 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.

Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0°C.

Outcome measures

Outcome measures
Measure	Cervarix Group n=576 Participants Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 1	76 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 1	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 1	35 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	120 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	53 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 1	46 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 1	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 1	10 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	90 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	29 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	91 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	39 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Rash, Dose 1	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 1	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 1	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Urticaria, Dose 1	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 1	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 1	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 2	43 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 2	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 2	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	81 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	35 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 2	32 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 2	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 2	9 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	55 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	20 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	52 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	20 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Rash, Dose 2	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 2	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 2	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Urticaria, Dose 2	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 2	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 2	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 3	30 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 3	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 3	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 3	57 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 3	3 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 3	28 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 3	12 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 3	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 3	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Dose 3	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Dose 3	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Dose 3	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 3	39 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 3	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 3	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 3	30 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 3	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 3	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Rash, Dose 3	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Dose 3	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Rash, Dose 3	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Urticaria, Dose 3	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Dose 3	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Dose 3	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Across doses	102 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Across doses	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Across doses	48 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	165 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	11 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	72 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	32 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	19 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal, Across doses	68 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal, Across doses	4 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal, Across doses	19 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	127 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	47 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	115 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	7 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	51 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Rash, Across doses	17 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Rash, Across doses	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Rash, Across doses	8 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Urticaria, Across doses	14 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Urticaria, Across doses	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Urticaria, Across doses	4 Participants

PRIMARY outcome

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

Population: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.

An 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Cervarix Group n=596 Participants Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	20 Participants
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	3 Participants
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	2 Participants
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 and Related AE(s)	0 Participants

PRIMARY outcome

Timeframe: During the entire study period (from Day 0 up to Month 7)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Cervarix Group n=596 Participants Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Any SAE(s)	4 Participants
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Grade 3 SAE(s)	1 Participants
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) Related SAE(s)	0 Participants

Adverse Events

Cervarix Group

Serious events: 4 serious events

Other events: 443 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cervarix Group n=596 participants at risk Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Infections and infestations Bronchitis	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Blood and lymphatic system disorders Iron deficiency anaemia	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Cardiac disorders Mitral valve prolapse	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Reproductive system and breast disorders Ovarian cyst	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Typhoid fever	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Urinary tract infection	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.17% 1/596 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).

Other adverse events

Other adverse events
Measure	Cervarix Group n=596 participants at risk Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.
Gastrointestinal disorders Abdominal pain lower	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Musculoskeletal and connective tissue disorders Arthralgia	17.1% 102/596 • Number of events 149 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Respiratory, thoracic and mediastinal disorders Asthma	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Musculoskeletal and connective tissue disorders Back pain	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Chills	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Respiratory, thoracic and mediastinal disorders Cough	0.67% 4/596 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Skin and subcutaneous tissue disorders Erythema	28.2% 168/596 • Number of events 291 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Fatigue	27.7% 165/596 • Number of events 258 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Gastrointestinal disorders Gastrointestinal disorder	11.4% 68/596 • Number of events 93 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Nervous system disorders Headache	21.3% 127/596 • Number of events 184 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Herpes zoster	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Injection site erythema	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Injury, poisoning and procedural complications Limb injury	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Musculoskeletal and connective tissue disorders Myalgia	19.3% 115/596 • Number of events 173 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Nasopharyngitis	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Oedema peripheral	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Pain	72.1% 430/596 • Number of events 922 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Reproductive system and breast disorders Polycystic ovaries	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Skin and subcutaneous tissue disorders Pruritus	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Pyrexia	5.4% 32/596 • Number of events 42 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Skin and subcutaneous tissue disorders Rash	2.9% 17/596 • Number of events 20 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
General disorders Swelling	20.0% 119/596 • Number of events 183 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Upper respiratory tract infection	0.34% 2/596 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Urinary tract infection	1.2% 7/596 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Skin and subcutaneous tissue disorders Urticaria	2.3% 14/596 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).
Infections and infestations Vaginitis bacterial	0.17% 1/596 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: during the 30-day (Days 0-29) post-vaccination period; Serious adverse events: during the entire study period (from Day 0 up to Month 7). For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).

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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