Varicella
Conditions
Keywords
chickenpox, varicella, two-dose schedule, second year of life
Brief summary
The aim of this study is to evaluate a modified formulation of GSK Biologicals' live attenuated varicella vaccine. In vivo pre-clinical data show this change has no negative impact on vaccine safety. This present study is undertaken to rule out any negative impact on the immunogenicity and safety of GSK Biologicals' live attenuated varicella virus vaccine.
Interventions
BIOLOGICALVarilrix (inactivated varicella vaccine)
subcutaneously injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Months to 21 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 11 and 21 months of age at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to the first study vaccine dose until 42 days after second study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines which can be administered up to eight days before each study vaccine dose. * Previous vaccination against varicella. * Known history of clinical varicella. * Known exposure to varicella within 30 days prior to study start. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin. * Major congenital defects or serious chronic illness. * Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness. * Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C. * Residence in the same household as a high risk person e.g.: new-born infants (0-4 weeks of age), pregnant women who have a negative history of chickenpox, persons with known immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Against Varicella Zoster Virus (VZV) | At 43-57 days after the first vaccine dose (Week 6) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\]. |
| Antibody Concentrations Against Varicella Zoster Virus (VZV) | At 43-57 days after the first vaccine dose (Week 6) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Against Varicella Zoster Virus (VZV) | At 86-114 days after the second vaccine dose (Week 12) | Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\]. |
| Antibody Concentrations Against Varicella Zoster Virus (VZV) | At 86-114 days after the second vaccine dose (Week 12) | Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\]. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose | Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Seroconverted Subjects for Varicella Antibodies | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) | Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies \[i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4\] in the sera of subjects who were seronegative before vaccination. |
| Number of Subjects With Any Unsolicited Adverse Event (AE) | Within the 43-day (Days 0-42) post-vaccination period following each dose | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to study end (Day 86-114) | Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 43-day (Days 0-42) post-vaccination period following each dose | Assessed solicited general symptoms were fever \[defined as axillary fever ≥ 37.5 degrees Celsius (°C)\] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (\>) 39.0°C after vaccination. Grade 3 rash = more than (\>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination. |
| Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12) | Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination. |
Countries
Czechia, Hungary
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 |
|---|---|
| Varilrix HSA-Free Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). | 122 |
| Varilrix Group Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). | 122 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Varilrix HSA-Free Group | Varilrix Group | Total |
|---|---|---|---|
| Age, Continuous | 15.6 Months STANDARD_DEVIATION 3.34 | 14.8 Months STANDARD_DEVIATION 3.08 | 15.20 Months STANDARD_DEVIATION 3.23 |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 122 Participants | 122 Participants | 244 Participants |
| Sex: Female, Male Female | 59 Participants | 60 Participants | 119 Participants |
| Sex: Female, Male Male | 63 Participants | 62 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 122 | 0 / 122 |
| other Total, other adverse events | 103 / 122 | 100 / 122 |
| serious Total, serious adverse events | 2 / 122 | 5 / 122 |
Outcome results
Primary
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\].
Time frame: At 43-57 days after the first vaccine dose (Week 6)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Varilrix HSA-Free Group | Antibody Concentrations Against Varicella Zoster Virus (VZV) | 123.5 mIU/mL |
| Varilrix Group | Antibody Concentrations Against Varicella Zoster Virus (VZV) | 110.7 mIU/mL |
Comparison: Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.95% CI: [0.93, 1.33]ANOVA
Primary
Antibody Titers Against Varicella Zoster Virus (VZV)
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Time frame: At 43-57 days after the first vaccine dose (Week 6)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Varilrix HSA-Free Group | Antibody Titers Against Varicella Zoster Virus (VZV) | 172.6 Titers |
| Varilrix Group | Antibody Titers Against Varicella Zoster Virus (VZV) | 154.3 Titers |
Comparison: Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.95% CI: [0.86, 1.46]ANOVA
Secondary
Antibody Concentrations Against Varicella Zoster Virus (VZV)
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\].
Time frame: At 86-114 days after the second vaccine dose (Week 12)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Varilrix HSA-Free Group | Antibody Concentrations Against Varicella Zoster Virus (VZV) | 1013.6 mIU/mL |
| Varilrix Group | Antibody Concentrations Against Varicella Zoster Virus (VZV) | 999.2 mIU/mL |
Secondary
Antibody Titers Against Varicella Zoster Virus (VZV)
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Time frame: At 86-114 days after the second vaccine dose (Week 12)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Varilrix HSA-Free Group | Antibody Titers Against Varicella Zoster Virus (VZV) | 1452.5 Titers |
| Varilrix Group | Antibody Titers Against Varicella Zoster Virus (VZV) | 1395.4 Titers |
Secondary
Number of Seroconverted Subjects for Varicella Antibodies
Seroconversion/seroresponse (considering the IFA data) was defined as the appearance of anti-VZV antibodies \[i.e. titer/concentration greater than or equal to (≥) the assay cut-off value of 1:4\] in the sera of subjects who were seronegative before vaccination.
Time frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varilrix HSA-Free Group | Number of Seroconverted Subjects for Varicella Antibodies | Anti-VZV, Week 6 | 114 Participants |
| Varilrix HSA-Free Group | Number of Seroconverted Subjects for Varicella Antibodies | Anti-VZV, Week 12 | 115 Participants |
| Varilrix Group | Number of Seroconverted Subjects for Varicella Antibodies | Anti-VZV, Week 6 | 114 Participants |
| Varilrix Group | Number of Seroconverted Subjects for Varicella Antibodies | Anti-VZV, Week 12 | 112 Participants |
Secondary
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV antibody concentrations greater than or equal to (≥) the assay cut-off values of: 25 mIU/mL, 50 mIU/mL and 75 mIU/mL have been assesssed by ELISA, in the sera of subjects who were seronegative before vaccination.
Time frame: At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who were seronegative for varicella antibodies at baseline and for whom pre-vaccination and post-vaccination serology results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 50 mIU/mL, Week 12 | 116 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 25 mIU/mL, Week 12 | 116 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 75 mIU/mL, Week 6 | 89 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 50 mIU/mL, Week 6 | 105 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 75 mIU/mL, Week 12 | 116 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 25 mIU/mL, Week 6 | 114 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 75 mIU/mL, Week 12 | 114 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 25 mIU/mL, Week 12 | 114 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 50 mIU/mL, Week 6 | 103 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 50 mIU/mL, Week 12 | 114 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 75 mIU/mL, Week 6 | 89 Participants |
| Varilrix Group | Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values | Anti-VZV ≥ 25 mIU/mL, Week 6 | 113 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 13 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 33 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 5 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 23 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 44 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 6 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 18 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 14 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 15 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 18 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 3 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 34 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 7 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 46 Participants |
| Varilrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fever \[defined as axillary fever ≥ 37.5 degrees Celsius (°C)\] and generalized rash. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 fever = temperature above (\>) 39.0°C after vaccination. Grade 3 rash = more than (\>) 150 lesions. Related = considered by the investigator to be causally related to the study vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 64 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 13 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 1 | 1 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 54 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 6 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 3 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 1 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 31 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 2 | 0 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 31 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 1 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 23 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 1 | 52 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature, Dose 2 | 3 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 1 | 11 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 2 | 0 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 1 | 2 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature, Dose 2 | 0 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 1 | 0 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 0 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 53 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature, Dose 2 | 18 Participants |
| Varilrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 12 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Event (AE)
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: Within the 43-day (Days 0-42) post-vaccination period following each dose
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Varilrix HSA-Free Group | Number of Subjects With Any Unsolicited Adverse Event (AE) | Any AE(s), Dose 1 | 56 Participants |
| Varilrix HSA-Free Group | Number of Subjects With Any Unsolicited Adverse Event (AE) | Any AE(s), Dose 2 | 35 Participants |
| Varilrix Group | Number of Subjects With Any Unsolicited Adverse Event (AE) | Any AE(s), Dose 1 | 45 Participants |
| Varilrix Group | Number of Subjects With Any Unsolicited Adverse Event (AE) | Any AE(s), Dose 2 | 42 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 up to study end (Day 86-114)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Varilrix HSA-Free Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |
| Varilrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |