Infections, Papillomavirus
Conditions
Keywords
HPV vaccine, Healthy adolescents, Cervical cancer, Safety, Immunogenicity, Cervarix
Brief summary
Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.
Interventions
BIOLOGICALCervarix
Intramuscular injection, 3 doses
BIOLOGICALEngerix-B
Intramuscular injection, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 12 and 15 years of age at the time of the first vaccination. A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative. Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study. * Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse). * Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement. * If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
Exclusion criteria
* Previous vaccination against HPV or Hepatitis B virus. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F) / Axillary temperature \<37.5°C (99.5°F) / Rectal temperature \<38°C (100.4°F).) * Pregnant or lactating female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | At the time of Visit 5 (at 18.5 years of age) | The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group). |
| Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | 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) of injection site. |
| Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | During the 7-day post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), 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. |
| Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Within the 30-day post-vaccination period | 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 Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Within 30 minutes following each vaccination dose | The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame. |
| Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | At the time of Visit 5 (i.e. at 18.5 years of age) | The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group). Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure. |
| Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination | During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO) | During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis. |
| Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5) | Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section. |
| Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age) | The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age) | The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5. |
| Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | From Dose 1 (at Day 0) until Month 12 | MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury. |
Countries
Finland
Participant flow
Recruitment details
Immunization phase (Day 0 to Month 12) = adolescents (birth cohorts '92-'95) were vaccinated with Cervarix/Engerix-B. Effectiveness evaluation phase (Visit 5) = the vaccine's impact was assessed on female subjects aged 18.5. At Day 0, Cervarix was not licensed for males;male subjects receiving the vaccine were considered part of a Phase III trial.
Pre-assignment details
34412 subjects were enrolled in the study, out of which 2236 subjects had a subject number allocated, but did not receive a vaccine dose, and 1 subject was excluded due to non-eligibility criteria, hence 32175 subjects were vaccinated and started the study.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Pooled Group Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 14,837 |
| Engerix-B Pooled Group Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. | 17,338 |
| Total | 32,175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to follow-up, complete vaccination | 4,707 | 10,757 |
| Overall Study | Lost to follow-up,incomplete vaccination | 83 | 117 |
| Overall Study | Migrated/moved from study area | 13 | 11 |
| Overall Study | Other | 1,685 | 902 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Total | Cervarix Pooled Group | Engerix-B Pooled Group |
|---|---|---|---|
| Age, Continuous | 14.1 Years STANDARD_DEVIATION 0.8 | 14.1 Years STANDARD_DEVIATION 0.8 | 14.1 Years STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 17 Participants | 9 Participants | 8 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian heritage | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian heritage | 8 Participants | 8 Participants | 0 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese heritage | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian heritage | 17 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized Geographic ancestry Mixed origin | 195 Participants | 103 Participants | 92 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic/North African heritage | 70 Participants | 31 Participants | 39 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European heritage | 31859 Participants | 14669 Participants | 17190 Participants |
| Sex: Female, Male Female | 20518 Participants | 12399 Participants | 8119 Participants |
| Sex: Female, Male Male | 11657 Participants | 2438 Participants | 9219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14,837 | 0 / 17,338 |
| other Total, other adverse events | 506 / 643 | 411 / 1,047 |
| serious Total, serious adverse events | 188 / 14,837 | 152 / 17,338 |
Outcome results
Primary
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group
The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)
Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | 139 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | 117 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group | 329 Participants |
Comparison: Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.p-value: 0.00495% CI: [20.1, 68.2]Cochran-Mantel-Haenszel
Comparison: Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.p-value: 0.23295% CI: [-19, 51.1]Cochran-Mantel-Haenszel
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects
The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
Time frame: At the time of Visit 1 (Day 0), Visit 4 (at Month 7) and at the time of Visit 5 (18.5 years of age)
Population: The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0) | 4.5 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y) | 2759.5 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0) | 4.5 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7) | 21327.2 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y) | 2609.6 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0) | 3.8 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7) | 8583.9 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y) | 837.7 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0) | 3.9 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7) | 8227.3 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y) | 890.0 EL.U/mL |
| Cervarix/Engerix-B A Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7) | 23959.1 EL.U/mL |
Secondary
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group
The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group). Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure.
Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)
Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | 139 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group | 117 Participants |
Comparison: Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.p-value: 0.06995% CI: [-139.4, 3.3]Cochran-Mantel-Haenszel
Secondary
Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types
The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)
Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/35/39/45/51/52/56/58/59/66/68 | 923 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-18 | 62 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6 | 192 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11/53/74 | 403 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-11 | 39 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51 | 449 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11 | 221 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16 | 88 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 | 965 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51/52 | 563 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/45 | 97 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45 | 175 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6 | 183 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-18 | 41 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/45 | 93 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51 | 450 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51/52 | 585 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/35/39/45/51/52/56/58/59/66/68 | 961 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-11 | 32 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11 | 204 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11/53/74 | 381 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16 | 85 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45 | 173 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 | 999 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11/53/74 | 307 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-18 | 134 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16 | 227 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/45 | 182 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51/52 | 532 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 | 883 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45 | 271 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-11 | 34 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/35/39/45/51/52/56/58/59/66/68 | 776 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6/11 | 165 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-6 | 139 Participants |
| Engerix-B Group | Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51 | 441 Participants |
Secondary
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types
The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time frame: At the time of Visit 5 (i.e. at 18.5 years of age)
Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types | 27 Participants |
Secondary
Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types
The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).
Time frame: At the time of Visit 5 (at 18.5 years of age)
Population: The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45 | 9 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6 | 36 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51/52 | 63 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-11 | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/45 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6/11 | 41 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/35/39/45/51/52/56/58/59/66/68 | 129 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6/11/53/74 | 72 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51 | 53 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 | 136 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-18 | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-16 | 6 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-18 | 10 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/45 | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45 | 16 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51 | 42 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/45/51/52 | 49 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-31/33/35/39/45/51/52/56/58/59/66/68 | 79 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68 | 95 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6 | 27 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-11 | 5 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6/11 | 29 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-6/11/53/74 | 45 Participants |
| Cervarix/Engerix-B B Group | Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types | HPV-16 | 19 Participants |
Secondary
Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects
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) of injection site.
Time frame: During the 7-day post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Across doses | 169 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 1 | 463 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 1 | 12 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 1 | 99 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 1 | 61 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 1 | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 2 | 331 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 2 | 88 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 2 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 2 | 66 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 2 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 3 | 326 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 3 | 11 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 3 | 100 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 3 | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 3 | 69 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 3 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Across doses | 506 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Across doses | 26 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 1 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Across doses | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Across doses | 131 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Across doses | 8 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 2 | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 2 | 123 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Across doses | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 1 | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 3 | 108 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 1 | 90 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 1 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 3 | 18 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 1 | 29 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Across doses | 46 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 1 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 2 | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 2 | 59 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Across doses | 251 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Redness, Dose 2 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Across doses | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Swelling, Dose 2 | 16 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Across doses | 2 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Swelling, Dose 2 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Dose 3 | 50 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Pain, Dose 1 | 157 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Any Redness, Across doses | 131 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects | Grade 3 Pain, Dose 3 | 0 Participants |
Secondary
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), 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.
Time frame: During the 7-day post-vaccination period following each dose and across doses
Population: The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 1 | 45 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 1 | 58 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 1 | 37 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 1 | 224 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 1 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 1 | 156 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever (axillary), Dose 1 | 7 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 1 | 73 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 1 | 7 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 1 | 6 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 1 | 178 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 1 | 10 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 1 | 108 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 1 | 229 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 1 | 196 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 2 | 36 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 1 | 13 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 1 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 1 | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 1 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 2 | 100 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Dose 2 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 2 | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Across doses | 291 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Across doses | 233 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Across doses | 48 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Across doses | 106 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 2 | 27 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 2 | 101 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 2 | 55 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 2 | 151 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 2 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 2 | 143 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 2 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 3 | 53 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 3 | 41 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 3 | 135 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 3 | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 3 | 100 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Dose 3 | 15 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Dose 3 | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Dose 3 | 10 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 3 | 19 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 3 | 12 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 3 | 101 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 3 | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 3 | 69 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 3 | 158 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 3 | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 3 | 137 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 3 | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Across doses | 107 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever (axillary), Dose 1 | 15 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever (axillary), Dose 1 | 3 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 1 | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 2 | 41 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 2 | 136 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 2 | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Dose 2 | 19 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Dose 2 | 11 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 2 | 45 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 2 | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 2 | 9 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 2 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 2 | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 2 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 3 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 3 | 11 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Across doses | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Across doses | 87 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Across doses | 7 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Across doses | 6 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Across doses | 28 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Across doses | 11 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Across doses | 70 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Across doses | 261 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Across doses | 15 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Across doses | 176 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Across doses | 321 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Across doses | 12 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Across doses | 291 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Across doses | 29 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Across doses | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Across doses | 14 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Across doses | 4 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Across doses | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Across doses | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 2 | 2 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 3 | 39 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 1 | 6 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 1 | 58 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 3 | 123 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 1 | 45 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Across doses | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 1 | 301 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 3 | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 1 | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Across doses | 128 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 1 | 246 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever (axillary), Dose 1 | 4 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 3 | 97 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever (axillary), Dose 1 | 23 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 3 | 141 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 1 | 101 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 3 | 80 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Dose 3 | 24 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 1 | 84 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 1 | 255 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Across doses | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 1 | 7 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 3 | 69 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 1 | 181 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 3 | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 1 | 169 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 1 | 2 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 2 | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 3 | 8 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 2 | 33 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Across doses | 371 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 1 | 17 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 3 | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 1 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Across doses | 97 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 1 | 12 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Dose 1 | 12 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 1 | 11 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Dose 2 | 155 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Across doses | 211 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever (axillary), Dose 1 | 35 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Dose 2 | 10 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 2 | 50 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 3 | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 1 | 138 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Across doses | 21 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Across doses | 351 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Across doses | 14 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 2 | 38 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Across doses | 85 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Across doses | 4 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Across doses | 13 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Across doses | 23 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Across doses | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 2 | 5 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Urticaria, Across doses | 15 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Gastrointestinal, Dose 2 | 38 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Across doses | 81 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Headache, Dose 2 | 4 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fatigue, Across doses | 411 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Dose 2 | 104 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 2 | 7 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Dose 2 | 97 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 2 | 123 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Headache, Across doses | 280 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Dose 2 | 14 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Rash, Dose 2 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Rash, Dose 2 | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Dose 2 | 28 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Dose 2 | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Dose 2 | 2 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Arthralgia, Dose 3 | 33 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Arthralgia, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Rash, Across doses | 33 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Arthralgia, Dose 3 | 29 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Across doses | 9 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Headache, Dose 2 | 144 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fatigue, Dose 3 | 6 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Myalgia, Across doses | 250 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fatigue, Dose 3 | 116 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Myalgia, Dose 2 | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Gastrointestinal, Dose 3 | 2 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Fever, Dose 3 | 27 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Myalgia, Dose 2 | 77 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Grade 3 Fever, Dose 3 | 3 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Fever, Across doses | 53 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Across doses | 163 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Any Gastrointestinal, Dose 3 | 50 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects | Related Urticaria, Across doses | 13 Participants |
Secondary
Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects
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 the 30-day post-vaccination period
Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Any AEs | 157 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Grade 3 AEs | 31 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Related AEs | 12 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Grade 3 AEs | 46 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Related AEs | 19 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects | Any AEs | 202 Participants |
Secondary
Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Dose 1 (at Day 0) until Month 12
Population: The analysis was performed on the TVC - subset of male subjects with active follow-up Month 0-Month 12 for SAEs, which included the male subjects in the Diary Card subset and the remaining Cervarix/Engerix-B A Group male subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | Any SAEs | 58 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | Related SAEs | 4 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | Any SAEs | 25 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Any Serious Adverse Events (SAEs) and SAEs Causally Related to Vaccination, in a Subset of Subjects | Related SAEs | 1 Participants |
Secondary
Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects
MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time frame: From Dose 1 (at Day 0) until Month 12
Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | 47 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects Reporting Medically Significant Conditions (MSCs), in a Subset of Subjects | 76 Participants |
Secondary
Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects
The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.
Time frame: Within 30 minutes following each vaccination dose
Population: This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Missing urticaria/rash, Dose 3 | 1 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 1 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 2 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 3 | 630 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 3 | 0 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 2 | 634 Participants |
| Cervarix/Engerix-B A Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 1 | 643 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 2 | 1042 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 1 | 1047 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Missing urticaria/rash, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 1 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 2 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Confirmed urticaria/rash, Dose 3 | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Male Subjects With Urticaria/Rash Within 30 Minutes After Each Vaccination Dose, in a Subset of Subjects | Not confirmed urticaria/rash, Dose 3 | 1039 Participants |
Secondary
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO
Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy. Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section.
Time frame: During the entire study period (from Day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Population: The analysis was performed on the total number of pregnant subjects reported, part of the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Elective termination with no apparent anomaly | 454 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Molar pregnancy | 2 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Ectopic pregnancy | 5 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Live infant with no apparent anomaly | 254 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Spontaneous abortion with no apparent anomaly | 62 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Stillbirth with no apparent congenital anomaly | 0 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Stillbirth with no apparent congenital anomaly | 1 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Elective termination with no apparent anomaly | 332 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Ectopic pregnancy | 5 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Spontaneous abortion with no apparent anomaly | 45 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Live infant with no apparent anomaly | 183 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies With Onset During the Study Period, Retrieved From Medical Birth Registry and HILMO | Molar pregnancy | 1 Participants |
Secondary
Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Visit 5 [18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination | 25 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects Reporting SAEs Assessed by the Investigator as Possibly Related to Vaccination | 30 Participants |
Secondary
Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects
The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.
Time frame: At the time of Visit 1 (at Day 0), Visit 4 (at Month 7) and Visit 5 (at 18.5 years of age)
Population: The analysis was performed on the ATP cohort for immunogenicity-Immunogenicity subset, which comprised the same male study subjects from the Cervarix/Engerix-B A Group included in the Diary Card subset, plus approximately 1500 female study subjects from the same Cervarix/Engerix-B A Group, with assay results available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, males (Day 0) | 40 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, males (Month 7) | 536 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 19 EL.U/mL, males (18.5Y) | 217 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, females (Day 0) | 86 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 8 EL.U/mL, females (Month 7) | 1163 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-16 ≥ 19 EL.U/mL, females (18.5Y) | 688 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, males (Day 0) | 31 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, males (Month 7) | 535 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 18 EL.U/mL, males (18.5Y) | 217 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, females (Day 0) | 84 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 7 EL.U/mL, females (Month 7) | 1160 Participants |
| Cervarix/Engerix-B A Group | Number of Subjects With HPV-16 and HPV-18 Antibody Concentrations Equal to or Above the Cut-off Values, by Gender, in a Subset of Subjects | anti-HPV-18 ≥ 18 EL.U/mL, females (18.5Y) | 685 Participants |
Secondary
Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO)
NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.
Time frame: During the entire study period (from day 0 up to Visit 5 [at 18.5 years of age] or up to the day before 19 years of age for subjects who did not attend Visit 5)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix/Engerix-B A Group | Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO) | 149 Participants |
| Cervarix/Engerix-B B Group | Number of Subjects With New Onset of Autoimmune Diseases (NOADs), Retrieved From Care Register for Social Welfare and Health Care (HILMO) | 180 Participants |