Number of subjects from the interventional groups, with solicited local adverse events (AEs)
Assessed solicited local AEs are pain, redness and swelling at the injection site. Pain includes tenderness.
Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Number of subjects from the interventional groups, with solicited general AEs
Assessed solicited general AEs among Infants/Toddlers/Children < 6 years are:
Drowsiness
Fever*
Irritability/Fussiness
Loss of appetite
Gastrointestinal (GI) symptoms**
Assessed solicited general AEs among Children ≥ 6 years are:
Fatigue
Fever*
GI symptoms**
Headache
Myalgia
Shivering (chills)
Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Number of subjects from the control groups with solicited general symptoms
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are:
Drowsiness
Fever*
Irritability/Fussiness
Loss of appetite
GI symptoms**
Assessed solicited general symptoms among Children ≥ 6 years are:
Fatigue
Fever*
GI symptoms**
Headache
Myalgia
Shivering (chills)
Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Number of subjects from the control groups with solicited general symptoms
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are:
Drowsiness
Fever*
Irritability/Fussiness
Loss of appetite
GI symptoms**
Assessed solicited general symptoms among Children ≥ 6 years are:
Fatigue
Fever*
GI symptoms**
Headache
Myalgia
Shivering (chills)
Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Number of subjects from the interventional groups with unsolicited AEs after each vaccination
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the control groups with unsolicited symptoms
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the control groups with unsolicited symptoms
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology.
The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. The reporting period for any renal allograft rejection is from Visit Day 1 to the study end (month 2).
Number of subjects from the interventional groups with seizures
All seizures occurring within 30 days following study vaccination are reported.
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days after visit day 1 are reported, for the control groups.
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days of visit month 1 are reported, for the control groups
Number of subjects from the interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure.
Number of subjects from the non-interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
The geometric mean concentration (GMC) calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology.
The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Occurrence of Herpes Zoster cases
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Number of subjects from the interventional pooled age group with solicited local AEs
The pooled age group includes all subjects aged 1-17 years.
The assessed local AEs solicited are:
Pain
Redness
Swelling Note: Pain includes tenderness.
Number of subjects from the interventional pooled age group with solicited general AEs
The pooled age group includes all subjects aged 1-17 years.
The assessed solicited general AEs among Infants/Toddlers/Children < 6 years are:
Drowsiness
Fever*
Irritability/Fussiness
Loss of appetite
Gastrointestinal (GI) symptoms**
The assessed solicited general AEs among Children ≥ 6 years are:
Fatigue
Fever*
GI symptoms**
Headache
Myalgia
Shivering (chills)
Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Number of subjects from the non-interventional pooled age group with solicited general symptoms
The pooled age group includes all subjects aged 1-17 years.
The assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are:
Drowsiness
Fever*
Irritability/Fussiness
Loss of appetite
GI symptoms**
The assessed solicited general symptoms among Children ≥ 6 years are:
Fatigue
Fever*
GI symptoms**
Headache
Myalgia
Shivering (chills)
Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
The pooled age group includes all subjects aged 1-17 years. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology.
The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology.
The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Number of subjects from the pooled age groups with HZ
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Number of subjects from the interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring within 30 days following study vaccination are reported
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit day 1 are reported
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit month 1 are reported
Number of subjects from the interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years.
Generalized convulsive seizures are classified as follows:
Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations
Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations
Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above
Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
The Vaccine Response Rate for anti-gE antibodies is defined as the percentage of subjects who have at least:
a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or,
a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline.
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Median fold increase of anti-gE antibody concentrations
Median fold increase in antibody concentration with 95% Confidence Interval is tabulated for the interventional groups by age strata (1-11 years and 12-17 years) This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation.
Median fold increase in antibody concentration with 95% Confidence Interval is to be tabulated for the interventional groups by pooled age category (1-17 years).
This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)