Clinical Trial Results:
A Phase IIIb, open, randomized study to evaluate non-inferiority of GSK Biologicals’ measles-mumps-rubella-varicella vaccine versus co-administration of GSK Biologicals’ Priorix™ and Varilrix™ in healthy children during their second year of life
Summary
|
|
EudraCT number |
2011-004485-15 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
27 May 2010
|
Results information
|
|
Results version number |
v2(current) |
This version publication date |
31 May 2023
|
First version publication date |
30 Jul 2015
|
Other versions |
v1 |
Version creation reason |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
110876
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00751348 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
15 Oct 2010
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
27 May 2010
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
27 May 2010
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To demonstrate the non-inferiority of GSK Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-Oka) vaccine to Priorix and Varilrix vaccines administered as concomitant, separate injections in terms of measles, mumps, rubella, and varicella zoster virus (VZV) seroconversion rates 42-56 days after vaccination.
|
||
Protection of trial subjects |
The subjects were observed closely for at least 30 minutes following the administration of vaccine(s), with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Oct 2008
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Korea, Republic of: 474
|
||
Worldwide total number of subjects |
474
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
474
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||
Recruitment
|
|||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||
Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | ||||||||||||||||||
Period 1
|
|||||||||||||||||||
Period 1 title |
Overall Trial (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
Arm title
|
Priorix-Tetra Group | ||||||||||||||||||
Arm description |
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. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Priorix-Tetra
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
MMRV
|
||||||||||||||||||
Pharmaceutical forms |
Powder and solvent for solution for injection
|
||||||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||||||
Dosage and administration details |
One dose of Priorix-Tetra vaccine was administered in the deltoid region of the left upper arm at Day 0.
|
||||||||||||||||||
Arm title
|
Priorix + Varilrix Group | ||||||||||||||||||
Arm description |
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. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Priorix
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
MMR
|
||||||||||||||||||
Pharmaceutical forms |
Powder and solvent for solution for injection
|
||||||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||||||
Dosage and administration details |
One dose of Priorix vaccine was administered in the deltoid region of the left upper arm at Day 0.
|
||||||||||||||||||
Investigational medicinal product name |
Varilrix
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
|||||||||||||||||||
Pharmaceutical forms |
Powder and solvent for solution for injection
|
||||||||||||||||||
Routes of administration |
Subcutaneous use
|
||||||||||||||||||
Dosage and administration details |
One dose of Varilrix vaccine was administered in the deltoid region of the right upper arm at Day 0.
|
||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Priorix-Tetra Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Priorix + Varilrix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Priorix-Tetra Group
|
||
Reporting group description |
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. | ||
Reporting group title |
Priorix + Varilrix Group
|
||
Reporting group description |
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. |
|
||||||||||||||||||||||
End point title |
Number of subjects seroconverted for measles, mumps, rubella and varicella zoster virus (VZV) antibodies above the cut-off values | |||||||||||||||||||||
End point description |
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.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
At 42 days post-vaccination
|
|||||||||||||||||||||
|
||||||||||||||||||||||
Statistical analysis title |
Non-inferiority - vaccine response to anti-measles | |||||||||||||||||||||
Statistical analysis description |
Non-inferiority of Priorix-Tetra vaccine vs Priorix and Varilrix administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.
|
|||||||||||||||||||||
Comparison groups |
Priorix-Tetra Group v Priorix + Varilrix Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
457
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [1] | |||||||||||||||||||||
P-value |
< 0.05 [2] | |||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||
Parameter type |
Difference in percentage | |||||||||||||||||||||
Point estimate |
-1.36
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-3.77 | |||||||||||||||||||||
upper limit |
1.66 | |||||||||||||||||||||
Variability estimate |
Standard deviation
|
|||||||||||||||||||||
Notes [1] - Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%. [2] - The P-value for all reactogenicity comparisons was below (<) 0.05. |
||||||||||||||||||||||
Statistical analysis title |
Non-inferiority - vaccine response to anti-mumps | |||||||||||||||||||||
Statistical analysis description |
Non-inferiority of Priorix-Tetra vaccine vs Priorix and Varilrix administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.
|
|||||||||||||||||||||
Comparison groups |
Priorix-Tetra Group v Priorix + Varilrix Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
457
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [3] | |||||||||||||||||||||
P-value |
< 0.05 [4] | |||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||
Parameter type |
Difference in percentage | |||||||||||||||||||||
Point estimate |
-5.34
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-10.4 | |||||||||||||||||||||
upper limit |
0.38 | |||||||||||||||||||||
Variability estimate |
Standard deviation
|
|||||||||||||||||||||
Notes [3] - Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%. [4] - The P-value for all reactogenicity comparisons was below (<) 0.05. |
||||||||||||||||||||||
Statistical analysis title |
Non-inferiority - vaccine response to anti-rubella | |||||||||||||||||||||
Statistical analysis description |
Non-inferiority of Priorix-Tetra vaccine vs Priorix and Varilrix administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.
|
|||||||||||||||||||||
Comparison groups |
Priorix-Tetra Group v Priorix + Varilrix Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
457
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [5] | |||||||||||||||||||||
P-value |
< 0.05 [6] | |||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||
Parameter type |
Difference in percentage | |||||||||||||||||||||
Point estimate |
-0.34
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-1.88 | |||||||||||||||||||||
upper limit |
2.06 | |||||||||||||||||||||
Variability estimate |
Standard deviation
|
|||||||||||||||||||||
Notes [5] - Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%. [6] - The P-value for all reactogenicity comparisons was below (<) 0.05. |
||||||||||||||||||||||
Statistical analysis title |
Non-inferiority - vaccine response to anti-VZV | |||||||||||||||||||||
Statistical analysis description |
Non-inferiority of Priorix-Tetra vaccine vs Priorix and Varilrix administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.
|
|||||||||||||||||||||
Comparison groups |
Priorix-Tetra Group v Priorix + Varilrix Group
|
|||||||||||||||||||||
Number of subjects included in analysis |
457
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
non-inferiority [7] | |||||||||||||||||||||
P-value |
< 0.05 [8] | |||||||||||||||||||||
Method |
Fisher exact | |||||||||||||||||||||
Parameter type |
Difference in percentage | |||||||||||||||||||||
Point estimate |
-1.06
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-3.07 | |||||||||||||||||||||
upper limit |
1.44 | |||||||||||||||||||||
Variability estimate |
Standard deviation
|
|||||||||||||||||||||
Notes [7] - Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%. [8] - The P-value for all reactogenicity comparisons was below (<) 0.05. |
|
||||||||||||||||
End point title |
Antibody concentrations against measles | |||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At 42-days post-vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Antibody concentrations against mumps | |||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At 42-days post-vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Antibody concentrations against rubella | |||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At 42 days post-vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Antibody titers against varicella viruses | |||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At 42 days post-vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with any and Grade 3 solicited local symptoms | |||||||||||||||||||||||||||
End point description |
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.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with any, grade 3 and related solicited general symptoms | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
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.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
During the 43-day (Days 0-42) post-vaccination period
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any unsolicited adverse events (AEs) | ||||||||||||
End point description |
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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within the 43-day (Days 0-42) post-vaccination period
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||
End point description |
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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the entire study period (from Day 0 up to Day 43 or Day 57)
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
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).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Priorix-Tetra Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Priorix + Varilrix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed). [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed). [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed). [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed). |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |