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Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

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ClinicalTrials.gov Identifier: NCT00751348
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : April 24, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Measles
Varicella
Mumps
Rubella
Interventions Biological: PriorixTM
Biological: VarilrixTM
Biological: Priorix-Tetra®
Enrollment 475
Recruitment Details Out of 475 subjects enrolled in the study, one did not receive any vaccination.
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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. 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.
Period Title: Overall Study
Started 313 161
Completed 307 159
Not Completed 6 2
Reason Not Completed
Withdrawal by Subject             5             2
Migration from study area             1             0
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group Total
Hide Arm/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. 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 of all reporting groups
Overall Number of Baseline Participants 313 161 474
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 313 participants 161 participants 474 participants
12.4  (1.4) 12.5  (1.65) 12.43  (1.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 161 participants 474 participants
Female
128
  40.9%
76
  47.2%
204
  43.0%
Male
185
  59.1%
85
  52.8%
270
  57.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 313 participants 161 participants 474 participants
Asian–East Asian Heritage
313
 100.0%
159
  98.8%
472
  99.6%
Asian-South East Asian Heritage
0
   0.0%
2
   1.2%
2
   0.4%
1.Primary Outcome
Title Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Hide 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.
Time Frame At 42 days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 300 157
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-Measles Number Analyzed 300 participants 156 participants
294
  98.0%
155
  99.4%
Anti-Mumps Number Analyzed 295 participants 154 participants
262
  88.8%
145
  94.2%
Anti-Rubella Number Analyzed 298 participants 157 participants
297
  99.7%
157
 100.0%
Anti-VZV Number Analyzed 283 participants 151 participants
280
  98.9%
151
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra Group, Priorix + Varilrix Group
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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%.
Statistical Test of Hypothesis P-Value <0.05
Comments The P-value for all reactogenicity comparisons was below (<) 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-3.77 to 1.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra Group, Priorix + Varilrix Group
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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%.
Statistical Test of Hypothesis P-Value <0.05
Comments The P-value for all reactogenicity comparisons was below (<) 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -5.34
Confidence Interval (2-Sided) 95%
-10.4 to 0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra Group, Priorix + Varilrix Group
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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%.
Statistical Test of Hypothesis P-Value <0.05
Comments The P-value for all reactogenicity comparisons was below (<) 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.34
Confidence Interval (2-Sided) 95%
-1.88 to 2.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra Group, Priorix + Varilrix Group
Comments 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.
Type of Statistical Test Non-Inferiority
Comments 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%.
Statistical Test of Hypothesis P-Value <0.05
Comments The P-value for all reactogenicity comparisons was below (<) 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-3.07 to 1.44
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Antibody Concentrations Against Measles
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame At 42-days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 300 156
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
4978.6
(4579.8 to 5412.1)
3433.6
(3116.3 to 3783.2)
3.Secondary Outcome
Title Antibody Concentrations Against Mumps
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
Time Frame At 42-days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 295 154
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
1012.3
(894.4 to 1145.7)
934.3
(805.2 to 1084.1)
4.Secondary Outcome
Title Antibody Concentrations Against Rubella
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame At 42-days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 298 157
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
63.4
(57.9 to 69.4)
75.7
(68 to 84.3)
5.Secondary Outcome
Title Antibody Titers Against Varicela Viruses
Hide Description Antibody titers were presented as geometric mean titers (GMTs).
Time Frame At 42-days post-vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 283 151
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
134.1
(117 to 153.7)
129.2
(109.8 to 152)
6.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide 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.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptoms sheet filled in.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 310 159
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
15
   4.8%
10
   6.3%
Grade 3 Pain
0
   0.0%
0
   0.0%
Any Redness
26
   8.4%
21
  13.2%
Grade 3 Redness
0
   0.0%
1
   0.6%
Any Swelling
5
   1.6%
5
   3.1%
Grade 3 Swelling
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide 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.
Time Frame During the 43-day (Days 0-42) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had the symptoms sheet filled in.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 310 159
Measure Type: Count of Participants
Unit of Measure: Participants
Any Temperature
202
  65.2%
82
  51.6%
Grade 3 Temperature
53
  17.1%
19
  11.9%
Related Temperature
31
  10.0%
12
   7.5%
Any Rash
33
  10.6%
16
  10.1%
Grade 3 Rash
0
   0.0%
0
   0.0%
Related Rash
3
   1.0%
1
   0.6%
Any Meningism
2
   0.6%
0
   0.0%
Grade 3 Meningism
0
   0.0%
0
   0.0%
Related Meningism
0
   0.0%
0
   0.0%
Any Parotid gland swelling
0
   0.0%
0
   0.0%
Grade 3 Parotid gland swelling
0
   0.0%
0
   0.0%
Related Parotid gland swelling
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide 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.
Time Frame Within the 43-day (Days 0-42) post-vaccination period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 313 161
Measure Type: Count of Participants
Unit of Measure: Participants
194
  62.0%
88
  54.7%
9.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide 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.
Time Frame During the entire study period (from Day 0 up to Day 43 or Day 57)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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.
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 Number of Participants Analyzed 313 161
Measure Type: Count of Participants
Unit of Measure: Participants
25
   8.0%
12
   7.5%
Time Frame 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 Description The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
 
Arm/Group Title Priorix-Tetra Group Priorix + Varilrix Group
Hide Arm/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. 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.
All-Cause Mortality
Priorix-Tetra Group Priorix + Varilrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/313 (0.00%)   0/161 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Priorix-Tetra Group Priorix + Varilrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   25/313 (7.99%)   12/161 (7.45%) 
General disorders     
Pyrexia  1  1/313 (0.32%)  0/161 (0.00%) 
Hepatobiliary disorders     
Hepatitis  1  0/313 (0.00%)  1/161 (0.62%) 
Infections and infestations     
Acute tonsillitis  1  1/313 (0.32%)  0/161 (0.00%) 
Bronchiolitis  1  3/313 (0.96%)  2/161 (1.24%) 
Bronchopneumonia  1  6/313 (1.92%)  3/161 (1.86%) 
Croup infectious  1  2/313 (0.64%)  0/161 (0.00%) 
Gastroenteritis  1  5/313 (1.60%)  6/161 (3.73%) 
Gastroenteritis norovirus  1  1/313 (0.32%)  0/161 (0.00%) 
Gastroenteritis rotavirus  1  2/313 (0.64%)  0/161 (0.00%) 
Hand-foot-and-mouth disease  1  0/313 (0.00%)  1/161 (0.62%) 
Herpangina  1  1/313 (0.32%)  0/161 (0.00%) 
Otitis media  1  1/313 (0.32%)  0/161 (0.00%) 
Otitis media acute  1  3/313 (0.96%)  1/161 (0.62%) 
Pharyngitis  1  5/313 (1.60%)  1/161 (0.62%) 
Pharyngotonsillitis  1  4/313 (1.28%)  1/161 (0.62%) 
Pneumonia  1  1/313 (0.32%)  1/161 (0.62%) 
Rhinitis  1  1/313 (0.32%)  0/161 (0.00%) 
Urinary tract infection  1  0/313 (0.00%)  1/161 (0.62%) 
Viral rash  1  1/313 (0.32%)  0/161 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/313 (0.32%)  0/161 (0.00%) 
Metabolism and nutrition disorders     
Hypophagia  1  0/313 (0.00%)  1/161 (0.62%) 
Iron deficiency  1  0/313 (0.00%)  1/161 (0.62%) 
Nervous system disorders     
Febrile convulsion  1  2/313 (0.64%)  0/161 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/313 (0.32%)  1/161 (0.62%) 
1
Term from vocabulary, MedDRA 13.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Priorix-Tetra Group Priorix + Varilrix Group
Affected / at Risk (%) Affected / at Risk (%)
Total   243/313 (77.64%)   113/161 (70.19%) 
General disorders     
Pain  1  15/310 (4.84%)  10/159 (6.29%) 
Redness  1  26/310 (8.39%)  21/159 (13.21%) 
Fever  1  202/310 (65.16%)  82/159 (51.57%) 
Rash  1  33/310 (10.65%)  16/159 (10.06%) 
Infections and infestations     
Upper respiratory tract infection  1  63/313 (20.13%)  25/161 (15.53%) 
Nasopharyngitis  1  31/313 (9.90%)  14/161 (8.70%) 
Gastroenteritis  1  28/313 (8.95%)  13/161 (8.07%) 
Pharyngitis  1  27/313 (8.63%)  10/161 (6.21%) 
Bronchitis  1  26/313 (8.31%)  11/161 (6.83%) 
Pharyngotonsillitis  1  21/313 (6.71%)  10/161 (6.21%) 
Otitis media acute  1  13/313 (4.15%)  9/161 (5.59%) 
1
Term from vocabulary, MedDRA 13.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00751348     History of Changes
Other Study ID Numbers: 110876
First Submitted: September 10, 2008
First Posted: September 11, 2008
Results First Submitted: March 13, 2017
Results First Posted: April 24, 2017
Last Update Posted: June 8, 2018