Trial Outcomes & Findings for Study of Two Formulations of GSK Biologicals' Varicella Vaccine (NCT NCT00568334)
NCT ID: NCT00568334
Last Updated: 2018-06-08
Results Overview
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
244 participants
Primary outcome timeframe
At 43-57 days after the first vaccine dose (Week 6)
Results posted on
2018-06-08
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
121
|
121
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
Baseline characteristics by cohort
| Measure |
Varilrix HSA-Free Group
n=122 Participants
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).
|
Varilrix Group
n=122 Participants
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).
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.6 Months
STANDARD_DEVIATION 3.34 • n=5 Participants
|
14.8 Months
STANDARD_DEVIATION 3.08 • n=7 Participants
|
15.20 Months
STANDARD_DEVIATION 3.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
122 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=116 Participants
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).
|
Varilrix Group
n=115 Participants
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).
|
|---|---|---|
|
Antibody Titers Against Varicella Zoster Virus (VZV)
|
172.6 Titers
Interval 141.6 to 210.3
|
154.3 Titers
Interval 128.7 to 185.0
|
PRIMARY outcome
Timeframe: 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.
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 \[with anti-VZV concentration below (\<) 25 mIU/mL\].
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=116 Participants
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).
|
Varilrix Group
n=115 Participants
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).
|
|---|---|---|
|
Antibody Concentrations Against Varicella Zoster Virus (VZV)
|
123.5 mIU/mL
Interval 107.9 to 141.4
|
110.7 mIU/mL
Interval 98.4 to 124.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=116 Participants
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).
|
Varilrix Group
n=115 Participants
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).
|
|---|---|---|
|
Number of Seroconverted Subjects for Varicella Antibodies
Anti-VZV, Week 6
|
114 Participants
|
114 Participants
|
|
Number of Seroconverted Subjects for Varicella Antibodies
Anti-VZV, Week 12
|
115 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=116 Participants
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).
|
Varilrix Group
n=115 Participants
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).
|
|---|---|---|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 25 mIU/mL, Week 6
|
114 Participants
|
113 Participants
|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 25 mIU/mL, Week 12
|
116 Participants
|
114 Participants
|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 50 mIU/mL, Week 6
|
105 Participants
|
103 Participants
|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 50 mIU/mL, Week 12
|
116 Participants
|
114 Participants
|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 75 mIU/mL, Week 6
|
89 Participants
|
89 Participants
|
|
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
Anti-VZV ≥ 75 mIU/mL, Week 12
|
116 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 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.
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=115 Participants
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).
|
Varilrix Group
n=112 Participants
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).
|
|---|---|---|
|
Antibody Titers Against Varicella Zoster Virus (VZV)
|
1452.5 Titers
Interval 1240.7 to 1700.5
|
1395.4 Titers
Interval 1183.0 to 1645.9
|
SECONDARY outcome
Timeframe: 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.
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 \[with anti-VZV concentration below (\<) 25 mIU/mL\].
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=116 Participants
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).
|
Varilrix Group
n=114 Participants
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).
|
|---|---|---|
|
Antibody Concentrations Against Varicella Zoster Virus (VZV)
|
1013.6 mIU/mL
Interval 880.9 to 1166.4
|
999.2 mIU/mL
Interval 877.3 to 1138.1
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=121 Participants
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).
|
Varilrix Group
n=122 Participants
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).
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
13 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
33 Participants
|
34 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
23 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
44 Participants
|
46 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
18 Participants
|
14 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=121 Participants
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).
|
Varilrix Group
n=122 Participants
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).
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 1
|
64 Participants
|
52 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 1
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 1
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 1
|
54 Participants
|
53 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 1
|
6 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature, Dose 2
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature, Dose 2
|
31 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash, Dose 2
|
31 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash, Dose 2
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 43-day (Days 0-42) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=122 Participants
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).
|
Varilrix Group
n=122 Participants
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).
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Event (AE)
Any AE(s), Dose 1
|
56 Participants
|
45 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Event (AE)
Any AE(s), Dose 2
|
35 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Varilrix HSA-Free Group
n=122 Participants
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).
|
Varilrix Group
n=122 Participants
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).
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Participants
|
5 Participants
|
Adverse Events
Varilrix HSA-Free Group
Serious events: 2 serious events
Other events: 103 other events
Deaths: 0 deaths
Varilrix Group
Serious events: 5 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varilrix HSA-Free Group
n=122 participants at risk
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).
|
Varilrix Group
n=122 participants at risk
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).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Otitis media
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Gastroenteritis
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.82%
1/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
Other adverse events
| Measure |
Varilrix HSA-Free Group
n=122 participants at risk
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).
|
Varilrix Group
n=122 participants at risk
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).
|
|---|---|---|
|
General disorders
Pain (Dose 1)
|
10.7%
13/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
12.3%
15/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Redness (Dose 1)
|
27.3%
33/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
27.9%
34/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Swelling (Dose 1)
|
4.1%
5/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
5.7%
7/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Pain (Dose 2)
|
19.0%
23/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
14.9%
18/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Redness (Dose 2)
|
36.4%
44/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
38.0%
46/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Swelling (Dose 2)
|
14.9%
18/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
11.6%
14/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Fever (Dose 1)
|
52.9%
64/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
42.6%
52/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
General disorders
Fever (Dose 2)
|
44.6%
54/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
43.8%
53/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Bronchitis (Dose 1)
|
12.3%
15/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
6.6%
8/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Viral infection (Dose 1)
|
9.0%
11/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
9.0%
11/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Rhinitis (Dose 1)
|
4.9%
6/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
6.6%
8/122 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Bronchitis (Dose 2)
|
6.6%
8/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
9.1%
11/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Viral infection (Dose 2)
|
5.0%
6/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
10.7%
13/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
|
Infections and infestations
Rhinitis (Dose 2)
|
5.8%
7/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
0.83%
1/121 • Solicited local symptoms: during the 4-day (Days 0-3) post each dose. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post each dose. SAEs: during the entire study period (Day 0 to Day 86/114).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER