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Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children

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ClinicalTrials.gov Identifier: NCT01506193
Recruitment Status : Completed
First Posted : January 9, 2012
Results First Posted : January 9, 2017
Last Update Posted : August 17, 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 Rubella
Varicella
Measles
Mumps
Interventions Biological: PriorixTetra™
Biological: Meningitec
Enrollment 716
Recruitment Details  
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 + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Period Title: Overall Study
Started 351 183 182
Completed 337 179 168
Not Completed 14 4 14
Reason Not Completed
Protocol Violation             1             0             1
Migrated/moved from study area             0             0             1
Adverse event, non-fatal             0             0             1
Withdrawal by Subject             5             1             8
Lost to Follow-up             8             3             3
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group Total
Hide Arm/Group Description Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Total of all reporting groups
Overall Number of Baseline Participants 351 183 182 716
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 351 participants 183 participants 182 participants 716 participants
13.4  (0.6) 13.4  (0.6) 13.4  (0.7) 13.4  (0.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 351 participants 183 participants 182 participants 716 participants
Female
167
  47.6%
85
  46.4%
88
  48.4%
340
  47.5%
Male
184
  52.4%
98
  53.6%
94
  51.6%
376
  52.5%
1.Primary Outcome
Title Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Hide Description Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
Time Frame At 42 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 309 164
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-measles ≥ 150 mIU/mL Number Analyzed 307 participants 163 participants
305
  99.3%
162
  99.4%
Anti-mumps ≥ 231 U/ML Number Analyzed 309 participants 162 participants
292
  94.5%
151
  93.2%
Anti-rubella ≥ 4 IU/mL Number Analyzed 309 participants 164 participants
309
 100.0%
164
 100.0%
Anti-varicella ≥ 25 mIU/mL Number Analyzed 300 participants 159 participants
299
  99.7%
159
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra + Meningitec Group, Priorix-Tetra Group
Comments

Immune response for anti-measles antibodies

Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-1.82 to 2.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra + Meningitec Group, Priorix-Tetra Group
Comments

Immune response for anti-mumps antibodies

Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 1.29
Confidence Interval (2-Sided) 95%
-3.04 to 6.67
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra + Meningitec Group, Priorix-Tetra Group
Comments

Immune response for anti-rubella antibodies

Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1.23 to 2.29
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra + Meningitec Group, Priorix-Tetra Group
Comments

Immune response for anti-varicella antibodies

Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-1.87 to 2.03
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Seroprotected Subjects for rSBA-MenC Antibodies
Hide Description Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
Time Frame At 42 days after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.
Arm/Group Title Priorix-Tetra + Meningitec Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 291 143
Measure Type: Count of Participants
Unit of Measure: Participants
286
  98.3%
142
  99.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Priorix-Tetra + Meningitec Group, Meningitec Group
Comments

Immune response for rSBA-MenC antibodies

Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination.

Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be [–10%] or higher.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value -1.02
Confidence Interval (2-Sided) 95%
-3.39 to 2.24
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.
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 subjects with study vaccine administered, on subjects with their symptom sheets completed.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 337 177
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Meningitec Number Analyzed 336 participants 0 participants
79
  23.5%
Grade 3 Pain, Meningitec Number Analyzed 336 participants 0 participants
4
   1.2%
Any Pain, Priorix-Tetra Number Analyzed 337 participants 177 participants
78
  23.1%
31
  17.5%
Grade 3 Pain, Priorix-Tetra Number Analyzed 337 participants 177 participants
1
   0.3%
1
   0.6%
Any Redness, Meningitec Number Analyzed 336 participants 0 participants
100
  29.8%
Grade 3 Redness, Meningitec Number Analyzed 336 participants 0 participants
9
   2.7%
Any Redness, Priorix-Tetra Number Analyzed 337 participants 177 participants
92
  27.3%
41
  23.2%
Grade 3 Redness, Priorix-Tetra Number Analyzed 337 participants 177 participants
4
   1.2%
1
   0.6%
Any Swelling, Meningitec Number Analyzed 336 participants 0 participants
68
  20.2%
Grade 3 Swelling, Meningitec Number Analyzed 336 participants 0 participants
9
   2.7%
Any Swelling, Priorix-Tetra Number Analyzed 337 participants 177 participants
47
  13.9%
20
  11.3%
Grade 3 Swelling, Priorix-Tetra Number Analyzed 337 participants 177 participants
1
   0.3%
2
   1.1%
4.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 15-day (Days 0-14) 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 subjects with study vaccine administered, on subjects with their symptom sheets completed.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 336 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
148
  44.0%
89
  50.3%
56
  32.7%
Grade 3 Drowsiness
16
   4.8%
12
   6.8%
6
   3.5%
Related Drowsiness
128
  38.1%
67
  37.9%
46
  26.9%
Any Irritability/Fussiness
187
  55.7%
104
  58.8%
84
  49.1%
Grade 3 Irritability/Fussiness
30
   8.9%
13
   7.3%
7
   4.1%
Related Irritability/Fussiness
158
  47.0%
82
  46.3%
64
  37.4%
Any Loss of appetite
178
  53.0%
99
  55.9%
60
  35.1%
Grade 3 Loss of appetite
25
   7.4%
12
   6.8%
5
   2.9%
Related Loss of appetite
138
  41.1%
75
  42.4%
43
  25.1%
5.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as 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 subjects with study vaccine administered, on subjects with their symptom sheets completed.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 336 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
Any Parotid / salivary gland swelling
3
   0.9%
4
   2.3%
0
   0.0%
Grade 3 Parotid / salivary gland swelling
0
   0.0%
0
   0.0%
0
   0.0%
Related Parotid / salivary gland swelling
3
   0.9%
3
   1.7%
0
   0.0%
Any Suspected signs of meningism
1
   0.3%
0
   0.0%
1
   0.6%
Grade 3 Suspected signs of meningism
0
   0.0%
0
   0.0%
0
   0.0%
Related Suspected signs of meningism
1
   0.3%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Subjects Reporting Fever Per Half Degree
Hide Description Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study 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 subjects with study vaccine administered, on subjects with their symptom sheets completed.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 336 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
Any temperature
159
  47.3%
86
  48.6%
46
  26.9%
Grade 3 temperature
15
   4.5%
9
   5.1%
4
   2.3%
Related temperature
178
  53.0%
84
  47.5%
28
  16.4%
7.Secondary Outcome
Title Number of Subjects Reporting Any, Localised and Generalised Rashes
Hide Description Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.
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 subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 337 177 171
Measure Type: Count of Participants
Unit of Measure: Participants
Any, Localised or generalised rash
91
  27.0%
41
  23.2%
15
   8.8%
Any, With fever rash
59
  17.5%
30
  16.9%
2
   1.2%
Any, Varicella like rash
6
   1.8%
1
   0.6%
1
   0.6%
Any, Measles/Rubella like rash
40
  11.9%
16
   9.0%
2
   1.2%
Any, Grade 3 rash
2
   0.6%
1
   0.6%
2
   1.2%
Any, Related rash
66
  19.6%
22
  12.4%
6
   3.5%
Localised, Any rash
43
  12.8%
13
   7.3%
9
   5.3%
Localised, Administration site rash
3
   0.9%
1
   0.6%
3
   1.8%
Localised, Other site rash
40
  11.9%
12
   6.8%
6
   3.5%
Localised, With fever rash
23
   6.8%
10
   5.6%
1
   0.6%
Localised, Varicella like rash
2
   0.6%
0
   0.0%
0
   0.0%
Localised, Measles/Rubella like rash
15
   4.5%
3
   1.7%
2
   1.2%
Localised, Grade 3 rash
0
   0.0%
0
   0.0%
1
   0.6%
Localised, Related rash
31
   9.2%
4
   2.3%
6
   3.5%
Generalised, Any rash
54
  16.0%
28
  15.8%
6
   3.5%
Generalised, With fever rash
38
  11.3%
20
  11.3%
1
   0.6%
Generalised, Varicella like rash
4
   1.2%
1
   0.6%
1
   0.6%
Generalised, Measles/Rubella like rash
25
   7.4%
13
   7.3%
0
   0.0%
Generalised, Grade 3 rash
2
   0.6%
1
   0.6%
1
   0.6%
Generalised, Related rash
39
  11.6%
18
  10.2%
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 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.
Time Frame Within 43 days (Days 0-42) after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 351 183 182
Measure Type: Count of Participants
Unit of Measure: Participants
97
  27.6%
61
  33.3%
41
  22.5%
9.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout study period (from Day 0 to approximately Month 4)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 351 183 182
Measure Type: Count of Participants
Unit of Measure: Participants
6
   1.7%
4
   2.2%
2
   1.1%
10.Secondary Outcome
Title Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Hide Description Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.
Time Frame At Day 42 after vaccination
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Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group
Hide Arm/Group Description:
Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
Overall Number of Participants Analyzed 309 164
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-measles Number Analyzed 307 participants 163 participants
2943.6
(2691.5 to 3219.2)
3158.5
(2749.7 to 3628)
Anti-mumps Number Analyzed 309 participants 162 participants
1530.7
(1368.4 to 1712.1)
1591.3
(1346.2 to 1881)
Anti-rubella Number Analyzed 309 participants 164 participants
40.2
(37.3 to 43.3)
44.9
(40.6 to 49.6)
Anti-varicella Number Analyzed 300 participants 159 participants
156.3
(143.9 to 169.8)
145.2
(129.5 to 162.8)
Time Frame Solicited local & general symptoms: during Days 0-3 and Days 0-14 post-vaccination period, respectively; Unsolicited AEs: during the 43 day (Days 0-42) post each vaccination; SAEs: throughout the entire study period (from Day 0 to approximately Month 4).
Adverse Event Reporting Description The number of occurrences reported for serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
 
Arm/Group Title Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Hide Arm/Group Description Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
All-Cause Mortality
Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/351 (1.71%)      4/183 (2.19%)      2/182 (1.10%)    
Gastrointestinal disorders       
Diarrhoea  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Dyspepsia  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Stomatitis  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Infections and infestations       
Gastroenteritis  1  1/351 (0.28%)  1 1/183 (0.55%)  1 0/182 (0.00%)  0
Gastroenteritis rotavirus  1  0/351 (0.00%)  0 1/183 (0.55%)  1 1/182 (0.55%)  1
Cellulitis  1  0/351 (0.00%)  0 1/183 (0.55%)  1 0/182 (0.00%)  0
Cellulitis orbital  1  0/351 (0.00%)  0 0/183 (0.00%)  0 1/182 (0.55%)  1
Gastroenteritis adenovirus  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Staphylococcal infection  1  0/351 (0.00%)  0 1/183 (0.55%)  1 0/182 (0.00%)  0
Injury, poisoning and procedural complications       
Skull fractured base  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/351 (0.00%)  0 1/183 (0.55%)  1 0/182 (0.00%)  0
Growth retardation  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Nervous system disorders       
Febrile convulsion  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Loss of consciousness  1  1/351 (0.28%)  1 0/183 (0.00%)  0 0/182 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Priorix-Tetra + Meningitec Group Priorix-Tetra Group Meningitec Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   327/351 (93.16%)      158/183 (86.34%)      146/182 (80.22%)    
Gastrointestinal disorders       
Diarrhoea  1  11/351 (3.13%)  11 10/183 (5.46%)  10 4/182 (2.20%)  4
General disorders       
Injection site pain  1  92/351 (26.21%)  92 31/183 (16.94%)  31 0/182 (0.00%)  0
Injection site swelling  1  79/351 (22.51%)  79 20/183 (10.93%)  20 1/182 (0.55%)  1
Injection site erythema  1  121/351 (34.47%)  121 41/183 (22.40%)  41 0/182 (0.00%)  0
Decreased appetite  1  178/351 (50.71%)  178 99/183 (54.10%)  99 60/182 (32.97%)  60
Irritability postvaccinal  1  187/351 (53.28%)  187 104/183 (56.83%)  104 84/182 (46.15%)  84
Pyrexia  1  220/351 (62.68%)  220 114/183 (62.30%)  114 64/182 (35.16%)  64
Infections and infestations       
Pharyngitis  1  16/351 (4.56%)  16 10/183 (5.46%)  10 9/182 (4.95%)  9
Nervous system disorders       
Somnolence  1  148/351 (42.17%)  148 89/183 (48.63%)  89 56/182 (30.77%)  56
Respiratory, thoracic and mediastinal disorders       
Cough  1  11/351 (3.13%)  11 10/183 (5.46%)  10 5/182 (2.75%)  5
Skin and subcutaneous tissue disorders       
Rash  1  91/351 (25.93%)  91 41/183 (22.40%)  41 15/182 (8.24%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01506193     History of Changes
Other Study ID Numbers: 115555
2011-001608-37 ( EudraCT Number )
First Submitted: January 5, 2012
First Posted: January 9, 2012
Results First Submitted: November 8, 2016
Results First Posted: January 9, 2017
Last Update Posted: August 17, 2018