Trial Outcomes & Findings for Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 (NCT NCT00751348)
NCT ID: NCT00751348
Last Updated: 2018-06-08
Results Overview
Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
475 participants
Primary outcome timeframe
At 42 days post-vaccination
Results posted on
2018-06-08
Participant Flow
Out of 475 subjects enrolled in the study, one did not receive any vaccination.
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 |
Priorix-Tetra Group
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Overall Study
STARTED
|
313
|
161
|
|
Overall Study
COMPLETED
|
307
|
159
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Priorix-Tetra Group
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Migration from study area
|
1
|
0
|
Baseline Characteristics
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
Baseline characteristics by cohort
| Measure |
Priorix-Tetra Group
n=313 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=161 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
Total
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.4 Months
STANDARD_DEVIATION 1.4 • n=5 Participants
|
12.5 Months
STANDARD_DEVIATION 1.65 • n=7 Participants
|
12.43 Months
STANDARD_DEVIATION 1.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian Heritage
|
313 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 42 days post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.
Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.
Outcome measures
| Measure |
Priorix-Tetra Group
n=300 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=157 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Anti-Measles
|
294 Participants
|
155 Participants
|
|
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Anti-Mumps
|
262 Participants
|
145 Participants
|
|
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Anti-Rubella
|
297 Participants
|
157 Participants
|
|
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Anti-VZV
|
280 Participants
|
151 Participants
|
SECONDARY outcome
Timeframe: At 42-days post-vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
Priorix-Tetra Group
n=300 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=156 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Antibody Concentrations Against Measles
|
4978.6 mIU/mL
Interval 4579.8 to 5412.1
|
3433.6 mIU/mL
Interval 3116.3 to 3783.2
|
SECONDARY outcome
Timeframe: At 42-days post-vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
Outcome measures
| Measure |
Priorix-Tetra Group
n=295 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=154 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Antibody Concentrations Against Mumps
|
1012.3 U/mL
Interval 894.4 to 1145.7
|
934.3 U/mL
Interval 805.2 to 1084.1
|
SECONDARY outcome
Timeframe: At 42-days post-vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Outcome measures
| Measure |
Priorix-Tetra Group
n=298 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=157 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Antibody Concentrations Against Rubella
|
63.4 IU/mL
Interval 57.9 to 69.4
|
75.7 IU/mL
Interval 68.0 to 84.3
|
SECONDARY outcome
Timeframe: At 42-days post-vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Priorix-Tetra Group
n=283 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=151 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Antibody Titers Against Varicela Viruses
|
134.1 Titers
Interval 117.0 to 153.7
|
129.2 Titers
Interval 109.8 to 152.0
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
Priorix-Tetra Group
n=310 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=159 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
15 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
26 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
Solicited general symptoms assessed were fever \[defined as rectal temperature ≥38.0 degrees Celsius (°C)\], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (\>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
Priorix-Tetra Group
n=310 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=159 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Rash
|
33 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Rash
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Meningism
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Temperature
|
202 Participants
|
82 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Temperature
|
53 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Temperature
|
31 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Rash
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Meningism
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Meningism
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Parotid gland swelling
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Parotid gland swelling
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Parotid gland swelling
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 43-day (Days 0-42) post-vaccination periodPopulation: 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 |
Priorix-Tetra Group
n=313 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=161 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
194 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 up to Day 43 or Day 57)Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Priorix-Tetra Group
n=313 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=161 Participants
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
25 Participants
|
12 Participants
|
Adverse Events
Priorix-Tetra Group
Serious events: 25 serious events
Other events: 243 other events
Deaths: 0 deaths
Priorix + Varilrix Group
Serious events: 12 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Priorix-Tetra Group
n=313 participants at risk
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=161 participants at risk
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Nervous system disorders
Febrile convulsion
|
0.64%
2/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Pyrexia
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Acute tonsillitis
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Bronchiolitis
|
0.96%
3/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
1.2%
2/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Bronchopneumonia
|
1.9%
6/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
1.9%
3/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Croup infectious
|
0.64%
2/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
5/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
3.7%
6/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.64%
2/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Herpangina
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Otitis media
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Otitis media acute
|
0.96%
3/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pharyngitis
|
1.6%
5/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pharyngotonsillitis
|
1.3%
4/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pneumonia
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Rhinitis
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.62%
1/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Viral rash
|
0.32%
1/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
Other adverse events
| Measure |
Priorix-Tetra Group
n=313 participants at risk
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
|
Priorix + Varilrix Group
n=161 participants at risk
Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.
|
|---|---|---|
|
General disorders
Pain
|
4.8%
15/310 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
6.3%
10/159 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Redness
|
8.4%
26/310 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
13.2%
21/159 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Fever
|
65.2%
202/310 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
51.6%
82/159 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Rash
|
10.6%
33/310 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
10.1%
16/159 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.1%
63/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
15.5%
25/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Nasopharyngitis
|
9.9%
31/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
8.7%
14/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis
|
8.9%
28/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
8.1%
13/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pharyngitis
|
8.6%
27/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
6.2%
10/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Bronchitis
|
8.3%
26/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
6.8%
11/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Pharyngotonsillitis
|
6.7%
21/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
6.2%
10/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Otitis media acute
|
4.2%
13/313 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
5.6%
9/161 • Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
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