Infections, Papillomavirus
Conditions
Brief summary
The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.
Interventions
BIOLOGICALCervarix vaccine
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
BIOLOGICALEngerix-B vaccine
All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
10 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* A male between, and including, 10 and 18 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to enrolment * For subjects below the legal age of consent, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Previous vaccination against Human Papillomavirus (HPV). * Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection. * Cancer or autoimmune disease under treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | At Month 7 | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL\] in the serum of subjects seronegative before vaccination. |
| Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | At Month 7 | Titers were presented as geometric mean titers (GMT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 7 days (Days 0-6) after each dose and across doses, up to 7 months | Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 50 mm. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 7 days (Days 0-6) after each dose and across doses, up to 7 months | Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature \> 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days (Day 0-29) after any vaccination, up to 7 months | 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 Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | At Month 2 | Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | At Month 2 and Month 7, post-vaccination | The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase \[ALT\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\] and hematocrit \[Hem\]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing. |
| Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12) | NOCDs include asthma, Chron's disease, dermatitis atopic. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury. |
| Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | At Month 2 | Titers were presented as GMTs. |
Countries
Finland
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. | 181 |
| Engerix-B Group Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12. | 89 |
| Total | 270 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse event, non-fatal | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Engerix-B Group | Total | Cervarix Group |
|---|---|---|---|
| Age, Continuous | 14.4 Years STANDARD_DEVIATION 2.02 | 14.4 Years STANDARD_DEVIATION 2.1 | 14.4 Years STANDARD_DEVIATION 2.14 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-Central/South Asian heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Not specified | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European heritage | 88 Participants | 265 Participants | 177 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 89 Participants | 270 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 89 |
| other Total, other adverse events | 170 / 181 | 73 / 89 |
| serious Total, serious adverse events | 3 / 181 | 1 / 89 |
Outcome results
Primary
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Titers were presented as geometric mean titers (GMT).
Time frame: At Month 7
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-16 | 22564.8 EL.U/mL |
| Cervarix Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-18 | 8460.3 EL.U/mL |
| Engerix-B Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-16 | 4.2 EL.U/mL |
| Engerix-B Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-18 | 3.6 EL.U/mL |
Primary
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL\] in the serum of subjects seronegative before vaccination.
Time frame: At Month 7
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-16 | 163 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-18 | 150 Participants |
| Engerix-B Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-16 | 1 Participants |
| Engerix-B Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-18 | 2 Participants |
Secondary
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Titers were presented as GMTs.
Time frame: At Month 2
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-16 | 5254.5 EL.U/mL |
| Cervarix Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-18 | 3696.9 EL.U/mL |
| Engerix-B Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-16 | 4.1 EL.U/mL |
| Engerix-B Group | Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18) | HPV-18 | 3.7 EL.U/mL |
Secondary
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
Time frame: At Month 2
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-16 | 165 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-18 | 152 Participants |
| Engerix-B Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-16 | 0 Participants |
| Engerix-B Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 | HPV-18 | 4 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (\>) 50 mm.
Time frame: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheet.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 2 | 114 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 1 | 149 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 1 | 24 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 2 | 30 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 2 | 20 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 3 | 115 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 3 | 33 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 3 | 29 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Across doses | 159 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 8 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Across doses | 51 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Across doses | 36 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Across doses | 7 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 3 | 16 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Across doses | 39 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 1 | 25 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 1 | 12 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 3 | 9 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 1 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Pain, Dose 2 | 16 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Dose 2 | 8 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 3 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Redness, Across doses | 15 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Swelling, Dose 2 | 2 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria. Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature \> 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had filled in the symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 1 | 17 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Athralgia, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Athralgia, Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 1 | 51 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 26 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 1 | 24 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 1 | 33 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 1 | 51 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 24 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 1 | 67 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Dose 1 | 45 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 1 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 2 | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 21 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 2 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 2 | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 2 | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 2 | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Maylagia, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Maylagia, Dose 2 | 27 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 2 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 3 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthtralgia, Dose 3 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 3 | 44 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 3 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 3 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 3 | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 17 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 3 | 39 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Dose 3 | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Across doses | 29 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Across doses | 82 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 52 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Across doses | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Across doses | 40 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Across doses | 77 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 43 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Across doses | 88 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Across doses | 70 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Across doses | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Across doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 2 | 6 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 2 | 8 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 3 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 1 | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Across doses | 10 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Athralgia, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Athralgia, Dose 1 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Across doses | 33 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 1 | 32 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthtralgia, Dose 3 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 18 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 3 | 15 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 1 | 11 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Across doses | 5 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 5 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 1 | 10 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 11 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 5 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Dose 3 | 4 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 1 | 21 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Across doses | 42 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Across doses | 2 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 1 | 16 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Dose 1 | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 3 | 5 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 1 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 16 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 33 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 4 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 1 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Arthralgia, Dose 2 | 3 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 3 | 11 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fever (axillary), Across doses | 17 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Fatigue, Dose 2 | 14 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Across doses | 23 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 8 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 9 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Myalgia, Dose 3 | 8 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Dose 2 | 4 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Dose 3 | 6 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Mylagia, Across doses | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Headache, Dose 2 | 13 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 3 | 2 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Gastrointestinal, Across doses | 14 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Maylagia, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Maylagia, Dose 2 | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Rash, Dose 2 | 2 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Mylagia, Across doses | 14 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Urticaria, Dose 2 | 2 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 7 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 3 | 0 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Day 0-29) after any vaccination, up to 7 months
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 68 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 5 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 31 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 2 Participants |
| Engerix-B Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 1 Participants |
Secondary
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase \[ALT\], basophils \[BAS\], creatinine \[CREA\], eosinophils \[EOS\] and hematocrit \[Hem\]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
Time frame: At Month 2 and Month 7, post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Above | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Normal | 14 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Above | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Normal | 102 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Below | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Above | 17 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Missing | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Normal | 108 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Below | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Above | 9 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Normal | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Normal | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Above | 30 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Normal | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Above | 27 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Normal | 158 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Above | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Normal | 159 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Above | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Normal | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Normal | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Normal | 155 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Above | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Normal | 147 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Below | 9 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Normal | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Normal | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Normal | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Normal | 166 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Below | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Normal | 165 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Above | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Normal | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Normal | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Above | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Above | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Normal | 140 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Missing | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Normal | 134 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Above | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Normal | 12 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Above | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Above | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Missing | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Below | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Normal | 73 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Missing | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Below | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Normal | 66 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Normal | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 7, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Normal | 48 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Normal | 65 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Above | 10 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 2, Missing | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Normal | 54 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Below | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Normal, Month 7, Above | 9 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Normal | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 2, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 2, Above | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Above, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | EOS Above, Month 7, Above | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Normal | 79 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Normal | 76 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Above | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Normal | 79 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 2, Missing | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 2, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Normal, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Normal | 81 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Normal | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Above, Month 2, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 2, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Normal, Month 7, Above | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | BAS Normal, Month 2, Missing | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | CREA Above, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Normal | 76 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | HEM Normal, Month 2, Above | 0 Participants |
Secondary
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelets \[PLA\], red blood cells \[RBC\] and white blood cells \[WBC\]. Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
Time frame: At Month 2 and at Month 7, post-vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Above | 12 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Above | 15 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Normal | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Above | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Below | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Above | 17 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Above | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Normal | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Above | 48 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Missing | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Normal | 13 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Normal | 93 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Above | 42 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Normal | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Below | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Below | 20 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Above | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Normal | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Normal | 135 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Normal | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Below | 14 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Normal | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Normal | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Above | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Normal | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Below | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Normal | 9 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Above | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Normal | 117 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Normal | 158 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Below | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Above | 18 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Normal | 130 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Missing | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Normal | 156 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Normal | 149 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Normal | 126 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Above | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Missing | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Normal | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Below | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Normal | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Normal | 148 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Above | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Normal | 92 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Below | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Above | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Below | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Normal | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Above | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Normal | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Normal | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Above | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Below | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Normal | 142 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Above | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Below | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Above | 15 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Normal | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Normal | 133 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Normal | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Normal | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Normal | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Below | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Above | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Normal | 60 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Above | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Above | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Missing | 7 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 7, Above | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Normal | 75 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Normal | 78 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Above | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Below | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Above | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Normal | 7 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Normal | 56 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Above | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 2, Missing | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Normal | 63 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Normal, Month 7, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 2, Above | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | LYM Above, Month 7, Normal | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Normal | 38 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Normal | 43 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Normal, Month 7, Above | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Normal | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Normal | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Normal | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 2, Above | 20 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Normal | 7 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | MON Above, Month 7, Above | 22 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Below | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 2, Missing | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Normal | 63 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Normal, Month 7, Below | 8 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Normal | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Below | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Normal | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Below | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | NEU Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Normal | 68 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Below | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 2, Missing | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Normal | 71 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Normal, Month 7, Above | 4 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Normal | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 2, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Below | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Below, Month 7, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | PLA Above, Month 2, Normal | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Above | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 2, Missing | 5 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Normal, Month 7, Below | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Below, Month 2, Above | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 2, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Normal | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | RBC Above, Month 7, Above | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Normal | 62 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Below | 3 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 2, Missing | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Normal | 66 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Normal, Month 7, Missing | 1 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Below, Month 7, Normal | 2 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Normal | 6 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Below | 0 Participants |
| Engerix-B Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | WBC Above, Month 7, Above | 1 Participants |
Secondary
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
NOCDs include asthma, Chron's disease, dermatitis atopic. MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time frame: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | NOCDs, Month 7 | 2 Participants |
| Cervarix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | MSCs, Month 7 | 22 Participants |
| Cervarix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | NOCDs, Month 7 to Month 12 | 0 Participants |
| Cervarix Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | MSCs, Month 7 to Month 12 | 1 Participants |
| Engerix-B Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | MSCs, Month 7 to Month 12 | 2 Participants |
| Engerix-B Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | NOCDs, Month 7 | 1 Participants |
| Engerix-B Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | NOCDs, Month 7 to Month 12 | 0 Participants |
| Engerix-B Group | Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | MSCs, Month 7 | 10 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available up to Month 7 and on the Extended Safety Follow-Up (ESFU) Total Vaccinated cohort, which included all vaccinated subjects that could be contacted by telephone for the Safety follow-up at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAEs, Month 7 | 2 Participants |
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | SAEs, Month 12 | 1 Participants |
| Engerix-B Group | Number of Subjects With Serious Adverse Events (SAEs) | SAEs, Month 7 | 0 Participants |
| Engerix-B Group | Number of Subjects With Serious Adverse Events (SAEs) | SAEs, Month 12 | 1 Participants |