Infections, Papillomavirus, Papillomavirus Vaccines
Conditions
Brief summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.
Interventions
BIOLOGICALCervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* A female subject between, and including, 18 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to enrolment. * Subject must have a negative urine pregnancy test. * Healthy subject before entering the study entry as established by medical history and physical examination. * Subject must be of non-childbearing potential.
Exclusion criteria
* pregnant or breastfeeding subject. * previous vaccination against human papillomavirus (HPV). * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality. * History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | At Month 7 | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay \[ELISA\] units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination. |
| Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | At Month 7 | Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-days (Day 0-6) post-vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-days (Day 0-6) post-vaccination | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination. |
| Number of Subjects With New Onset Chronic Diseases (NOCDs) | From Month 0 to Month 7 | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Medically Significant Adverse Events (MSAEs) | From Month 0 to Month 7 | MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | At Month 2 | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination. |
| Number of Subjects With MSAEs | From Month 0 to Month 12 | MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days (Day 0-29) post vaccination | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 to Month 7 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With (NOCDs) | From Month 0 to Month 12 | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | At Month 2 | Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL . |
Countries
Denmark, Lithuania, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Lot1 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 1 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. | 199 |
| Cervarix Lot2 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 2 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. | 198 |
| Cervarix Lot3 Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine Lot 3 manufactured at 600L scale according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. | 201 |
| Cervarix Low Group Subjects aged between and including 18-25 years, who received one dose of Cervarix™ vaccine manufactured lower scale-80L according to a 0, 1, 6- month schedule and were followed up for 7 months after the first dose. Additionally, a telephone contact was foreseen at Month 12. The vaccine was administrated by intramuscular (IM) injection into the deltoid region of the non-dominant arm. | 200 |
| Total | 798 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 18 | 13 | 8 |
| Overall Study | Migrated/moved from study area | 3 | 0 | 2 | 7 |
| Overall Study | Non-serious Adverse Event | 2 | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Serious Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 3 | 2 |
Baseline characteristics
| Characteristic | Cervarix Lot1 Group | Cervarix Lot2 Group | Cervarix Lot3 Group | Cervarix Low Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 21.8 Years STANDARD_DEVIATION 2.08 | 21.8 Years STANDARD_DEVIATION 2.08 | 21.9 Years STANDARD_DEVIATION 2 | 22.0 Years STANDARD_DEVIATION 1.96 | 21.88 Years STANDARD_DEVIATION 2.03 |
| Sex: Female, Male Female | 199 Participants | 198 Participants | 201 Participants | 200 Participants | 798 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 196 / 199 | 194 / 198 | 191 / 201 | 581 / 598 | 194 / 200 |
| serious Total, serious adverse events | 6 / 199 | 1 / 198 | 2 / 201 | 9 / 598 | 3 / 200 |
Outcome results
Primary
Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 Enzyme-Linked Immunosorbent Assay \[ELISA\] units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time frame: At Month 7
Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-18 | 129 Participants |
| Cervarix Lot1 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-16 | 118 Participants |
| Cervarix Lot2 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-16 | 127 Participants |
| Cervarix Lot2 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-18 | 143 Participants |
| Cervarix Lot3 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-18 | 135 Participants |
| Cervarix Lot3 Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-16 | 126 Participants |
| Pooled Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-16 | 371 Participants |
| Pooled Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-18 | 407 Participants |
| Cervarix Low Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-16 | 102 Participants |
| Cervarix Low Group | Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) | Anti-HPV-18 | 117 Participants |
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [0.81, 1.34]ANOVA
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [0.95, 1.49]ANOVA
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [0.98, 1.63]ANOVA
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [1.18, 1.85]ANOVA
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [0.94, 1.55]ANOVA
Comparison: To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.95% CI: [1, 1.55]ANOVA
Comparison: To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).95% CI: [-3.63, 1.02]Proc StatXact 5.0
Comparison: To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).95% CI: [-3.18, 0.94]Proc StatXact 5.0
Comparison: To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).95% CI: [0.7, 1.08]ANOVA
Comparison: To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).95% CI: [0.66, 0.97]ANOVA
Primary
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL.
Time frame: At Month 7
Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 54 Participants |
| Cervarix Lot1 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 43 Participants |
| Cervarix Lot2 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 22 Participants |
| Cervarix Lot2 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 38 Participants |
| Cervarix Lot3 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 43 Participants |
| Cervarix Lot3 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 34 Participants |
| Pooled Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 57 Participants |
| Pooled Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 41 Participants |
Secondary
Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations ≥8 ELISA units per milliliter \[EL.U/mL\] and anti-HPV-18 concentrations ≥7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time frame: At Month 2
Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 117 Participants |
| Cervarix Lot1 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 128 Participants |
| Cervarix Lot2 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 142 Participants |
| Cervarix Lot2 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 126 Participants |
| Cervarix Lot3 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 125 Participants |
| Cervarix Lot3 Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 134 Participants |
| Pooled Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 102 Participants |
| Pooled Group | Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 116 Participants |
Secondary
Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18
Seropositivity defined subjects with anti-HPV-16 antibody concentration ≥ 8 EL.U/mL and/or anti-HPV-18 antibody concentration ≥ 7 EL.U/mL .
Time frame: At Month 2
Population: The According-to-Protocol cohort for immunogenicity included all evaluable subjects from whom data concerning immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine component at Month 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 54 Participants |
| Cervarix Lot1 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 43 Participants |
| Cervarix Lot2 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 22 Participants |
| Cervarix Lot2 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 38 Participants |
| Cervarix Lot3 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 43 Participants |
| Cervarix Lot3 Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 34 Participants |
| Pooled Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-16 | 56 Participants |
| Pooled Group | Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 | Anti-HPV-18 | 41 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.
Time frame: During the 7-days (Day 0-6) post-vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 167 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 20 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 74 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 58 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 9 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 188 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 17 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 78 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 3 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 64 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 164 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 21 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 94 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 5 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 92 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 8 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across | 194 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across | 45 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across | 118 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across | 8 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across | 116 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across | 15 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 190 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across | 128 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across | 9 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 59 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 166 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 71 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across | 29 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 85 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across | 192 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across | 112 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 151 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 84 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 57 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 16 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 14 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 10 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 102 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across | 34 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 19 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across | 113 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 85 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across | 190 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 79 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 57 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across | 6 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across | 127 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 77 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 56 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 170 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 17 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 162 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 96 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 11 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 178 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 172 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 13 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 503 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across | 373 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 46 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 242 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 9 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 179 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 11 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across | 21 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 477 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 46 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across | 27 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 292 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 15 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 261 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across | 341 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 13 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across | 576 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 556 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 53 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across | 108 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 222 Participants |
| Pooled Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 3 | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 3 | 92 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 3 | 15 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 185 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across | 6 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 3 | 156 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 12 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 12 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 161 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 53 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 75 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across | 30 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 62 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across | 126 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across | 107 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 3 | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 3 | 82 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 54 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across | 192 Participants |
| Cervarix Low Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across | 10 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.
Time frame: During the 7-days (Day 0-6) post-vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 44 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 8 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 15 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 34 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 53 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 76 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 3 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 5 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 58 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 35 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 18 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 3 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 17 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 50 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 19 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 9 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 31 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 44 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 16 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 19 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 67 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 35 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 38 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 32 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 12 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 64 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 49 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 25 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 14 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 49 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 29 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 39 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 18 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 9 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 6 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 5 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 2 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 207 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 94 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 4 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 2 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 121 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 6 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 6 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 102 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 17 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 20 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 157 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 55 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 12 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 13 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 8 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 61 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 43 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 3 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 11 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 146 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 31 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 9 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 6 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 30 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 6 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 15 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 7 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 29 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 60 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 8 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 39 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 24 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 6 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 49 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 13 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 11 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.
Time frame: During the 7-days (Day 0-6) post-vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 5 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 32 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 69 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 45 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 44 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 60 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 3 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 81 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 4 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 19 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 4 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 36 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 14 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 17 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 39 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 55 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 19 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 24 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 84 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 70 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 49 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 62 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 7 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 5 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 17 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 44 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 8 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 48 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 34 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 50 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 3 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 41 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 13 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 19 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 60 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 38 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 6 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 3 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 73 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 105 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 51 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 170 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 60 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 121 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 15 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 6 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 14 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 8 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 131 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 14 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 39 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 199 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 150 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 3 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 238 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 11 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 19 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 42 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 17 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 14 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 30 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 61 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 65 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 30 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 80 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 46 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.
Time frame: During the 7-days (Day 0-6) post-vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 22 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 39 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 22 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 5 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 47 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 27 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 14 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 30 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 14 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 12 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 63 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 37 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 21 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 33 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 14 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 73 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 11 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 55 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 14 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 30 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 51 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 14 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 8 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 28 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 3 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 3 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 39 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 12 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 5 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 38 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 29 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 69 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 7 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 46 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 31 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 10 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 2 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 106 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 4 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 83 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 12 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 6 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 3 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 42 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 33 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 205 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 132 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 19 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 71 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 40 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 144 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 89 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 58 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 14 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 41 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 24 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 17 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 3 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 24 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 9 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 21 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 1 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 40 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 31 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.
Time frame: During the 7-days (Day 0-6) post-vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 55 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 32 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 6 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 90 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 14 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 62 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 38 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 3 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 4 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 2 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 31 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 75 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 117 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 6 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 16 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 99 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 68 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 13 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 7 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 11 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 117 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 77 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 95 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 18 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 32 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 9 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 70 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 5 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 7 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 103 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 38 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 5 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 40 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 10 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 82 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 1 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 61 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 11 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 6 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 19 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 95 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 22 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 13 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 7 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 32 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 106 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 8 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 14 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 8 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 57 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 5 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 57 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 73 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 2 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 33 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 6 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 62 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 78 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 194 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 202 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 1 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 27 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 297 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 22 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 340 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 173 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 110 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 5 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 230 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 40 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 103 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 27 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 9 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 17 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 263 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 85 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 48 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 19 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 31 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 10 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia | 35 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 90 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash | 11 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia | 48 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastro-intestinal | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 68 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria | 8 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 105 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastro-intestinal | 25 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 12 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 7 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia | 31 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 93 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 5 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastro-intestinal | 49 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria | 0 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia | 2 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria | 10 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 15 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia | 66 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash | 15 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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.
Time frame: Within 30 days (Day 0-29) post vaccination
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any (AEs) | 58 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related (AEs) | 22 Participants |
| Cervarix Lot1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 (AEs) | 5 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 (AEs) | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any (AEs) | 56 Participants |
| Cervarix Lot2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related (AEs) | 23 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 (AEs) | 14 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any (AEs) | 76 Participants |
| Cervarix Lot3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related (AEs) | 30 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any (AEs) | 190 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related (AEs) | 75 Participants |
| Pooled Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 (AEs) | 25 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 (AEs) | 7 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any (AEs) | 67 Participants |
| Cervarix Low Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related (AEs) | 32 Participants |
Secondary
Number of Subjects With Medically Significant Adverse Events (MSAEs)
MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Month 0 to Month 7
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Medically Significant Adverse Events (MSAEs) | 71 Participants |
| Cervarix Lot2 Group | Number of Subjects With Medically Significant Adverse Events (MSAEs) | 23 Participants |
Secondary
Number of Subjects With MSAEs
MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Month 0 to Month 12
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With MSAEs | 78 Participants |
| Cervarix Lot2 Group | Number of Subjects With MSAEs | 23 Participants |
Secondary
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Month 0 to Month 7
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 3 Participants |
| Cervarix Lot2 Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 7 Participants |
| Pooled Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 14 Participants |
| Cervarix Low Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 3 Participants |
Secondary
Number of Subjects With (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Month 0 to Month 12
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at last one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With (NOCDs) | 4 Participants |
| Cervarix Lot2 Group | Number of Subjects With (NOCDs) | 4 Participants |
| Cervarix Lot3 Group | Number of Subjects With (NOCDs) | 7 Participants |
| Pooled Group | Number of Subjects With (NOCDs) | 15 Participants |
| Cervarix Low Group | Number of Subjects With (NOCDs) | 3 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 12
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Cervarix Lot2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Cervarix Lot3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Pooled Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
| Cervarix Low Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Month 0 to Month 7
Population: The Total Vaccinated cohort included all vaccinated subjects. The Total vaccinated cohort for analysis of safety included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Lot1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Cervarix Lot2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Cervarix Lot3 Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Pooled Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| Cervarix Low Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |