Trial Outcomes & Findings for Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children (NCT NCT01506193)
NCT ID: NCT01506193
Last Updated: 2018-08-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
716 participants
Primary outcome timeframe
At 42 days after vaccination
Results posted on
2018-08-17
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Priorix-Tetra + Meningitec Group
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.
|
Priorix-Tetra Group
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.
|
Meningitec Group
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 Study
STARTED
|
351
|
183
|
182
|
|
Overall Study
COMPLETED
|
337
|
179
|
168
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
14
|
Reasons for withdrawal
| Measure |
Priorix-Tetra + Meningitec Group
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.
|
Priorix-Tetra Group
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.
|
Meningitec Group
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 Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Migrated/moved from study area
|
0
|
0
|
1
|
|
Overall Study
Adverse event, non-fatal
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
8
|
3
|
3
|
Baseline Characteristics
Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy Children
Baseline characteristics by cohort
| Measure |
Priorix-Tetra + Meningitec Group
n=351 Participants
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.
|
Priorix-Tetra Group
n=183 Participants
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.
|
Meningitec Group
n=182 Participants
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
n=716 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.4 Months
STANDARD_DEVIATION 0.6 • n=5 Participants
|
13.4 Months
STANDARD_DEVIATION 0.6 • n=7 Participants
|
13.4 Months
STANDARD_DEVIATION 0.7 • n=5 Participants
|
13.4 Months
STANDARD_DEVIATION 0.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
167 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
184 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
376 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 42 days after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=309 Participants
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.
|
Priorix-Tetra Group
n=164 Participants
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.
|
Meningitec Group
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.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Anti-measles ≥ 150 mIU/mL
|
305 Participants
|
162 Participants
|
—
|
|
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Anti-mumps ≥ 231 U/ML
|
292 Participants
|
151 Participants
|
—
|
|
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Anti-rubella ≥ 4 IU/mL
|
309 Participants
|
164 Participants
|
—
|
|
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Anti-varicella ≥ 25 mIU/mL
|
299 Participants
|
159 Participants
|
—
|
PRIMARY outcome
Timeframe: At 42 days after vaccinationPopulation: 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.
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=291 Participants
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.
|
Priorix-Tetra Group
n=143 Participants
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.
|
Meningitec Group
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.
|
|---|---|---|---|
|
Number of Seroprotected Subjects for rSBA-MenC Antibodies
|
286 Participants
|
142 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=337 Participants
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.
|
Priorix-Tetra Group
n=177 Participants
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.
|
Meningitec Group
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Meningitec
|
79 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Meningitec
|
4 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain, Priorix-Tetra
|
78 Participants
|
31 Participants
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Priorix-Tetra
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness, Meningitec
|
100 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Meningitec
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness, Priorix-Tetra
|
92 Participants
|
41 Participants
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Priorix-Tetra
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Meningitec
|
68 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Meningitec
|
9 Participants
|
—
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling, Priorix-Tetra
|
47 Participants
|
20 Participants
|
—
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Priorix-Tetra
|
1 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 15-day (Days 0-14) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=336 Participants
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.
|
Priorix-Tetra Group
n=177 Participants
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.
|
Meningitec Group
n=171 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
128 Participants
|
67 Participants
|
46 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
148 Participants
|
89 Participants
|
56 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
16 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/Fussiness
|
187 Participants
|
104 Participants
|
84 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/Fussiness
|
30 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/Fussiness
|
158 Participants
|
82 Participants
|
64 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
178 Participants
|
99 Participants
|
60 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
25 Participants
|
12 Participants
|
5 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
138 Participants
|
75 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=336 Participants
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.
|
Priorix-Tetra Group
n=177 Participants
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.
|
Meningitec Group
n=171 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Parotid / salivary gland swelling
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Parotid / salivary gland swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Parotid / salivary gland swelling
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Suspected signs of meningism
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Suspected signs of meningism
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Suspected signs of meningism
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 43-day (Days 0-42) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=336 Participants
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.
|
Priorix-Tetra Group
n=177 Participants
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.
|
Meningitec Group
n=171 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Fever Per Half Degree
Any temperature
|
159 Participants
|
86 Participants
|
46 Participants
|
|
Number of Subjects Reporting Fever Per Half Degree
Grade 3 temperature
|
15 Participants
|
9 Participants
|
4 Participants
|
|
Number of Subjects Reporting Fever Per Half Degree
Related temperature
|
178 Participants
|
84 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Within the 43-day (Days 0-42) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=337 Participants
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.
|
Priorix-Tetra Group
n=177 Participants
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.
|
Meningitec Group
n=171 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, With fever rash
|
38 Participants
|
20 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, Varicella like rash
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, Measles/Rubella like rash
|
25 Participants
|
13 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, Grade 3 rash
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, Related rash
|
39 Participants
|
18 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, Localised or generalised rash
|
91 Participants
|
41 Participants
|
15 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, With fever rash
|
59 Participants
|
30 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, Varicella like rash
|
6 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, Measles/Rubella like rash
|
40 Participants
|
16 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, Grade 3 rash
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Any, Related rash
|
66 Participants
|
22 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Any rash
|
43 Participants
|
13 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Administration site rash
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Other site rash
|
40 Participants
|
12 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, With fever rash
|
23 Participants
|
10 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Varicella like rash
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Measles/Rubella like rash
|
15 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Grade 3 rash
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Localised, Related rash
|
31 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Localised and Generalised Rashes
Generalised, Any rash
|
54 Participants
|
28 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 43 days (Days 0-42) after each vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=351 Participants
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.
|
Priorix-Tetra Group
n=183 Participants
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.
|
Meningitec Group
n=182 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
97 Participants
|
61 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: Throughout study period (from Day 0 to approximately Month 4)Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=351 Participants
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.
|
Priorix-Tetra Group
n=183 Participants
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.
|
Meningitec Group
n=182 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
6 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Priorix-Tetra + Meningitec Group
n=309 Participants
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.
|
Priorix-Tetra Group
n=164 Participants
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.
|
Meningitec Group
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.
|
|---|---|---|---|
|
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Anti-measles
|
2943.6 Titers
Interval 2691.5 to 3219.2
|
3158.5 Titers
Interval 2749.7 to 3628.0
|
—
|
|
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Anti-mumps
|
1530.7 Titers
Interval 1368.4 to 1712.1
|
1591.3 Titers
Interval 1346.2 to 1881.0
|
—
|
|
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Anti-rubella
|
40.2 Titers
Interval 37.3 to 43.3
|
44.9 Titers
Interval 40.6 to 49.6
|
—
|
|
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Anti-varicella
|
156.3 Titers
Interval 143.9 to 169.8
|
145.2 Titers
Interval 129.5 to 162.8
|
—
|
Adverse Events
Priorix-Tetra + Meningitec Group
Serious events: 6 serious events
Other events: 327 other events
Deaths: 0 deaths
Priorix-Tetra Group
Serious events: 4 serious events
Other events: 158 other events
Deaths: 0 deaths
Meningitec Group
Serious events: 2 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Priorix-Tetra + Meningitec Group
n=351 participants at risk
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.
|
Priorix-Tetra Group
n=183 participants at risk
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.
|
Meningitec Group
n=182 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Nervous system disorders
Febrile convulsion
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Nervous system disorders
Loss of consciousness
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Gastrointestinal disorders
Stomatitis
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/351 • 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).
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.
|
0.55%
1/183 • Number of events 1 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Infections and infestations
Gastroenteritis
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.55%
1/183 • Number of events 1 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/351 • 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).
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.
|
0.55%
1/183 • Number of events 1 • 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).
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.
|
0.55%
1/182 • Number of events 1 • 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).
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.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/351 • 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).
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.
|
0.55%
1/183 • Number of events 1 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/351 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.55%
1/182 • Number of events 1 • 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).
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.
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.28%
1/351 • Number of events 1 • 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).
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.
|
0.00%
0/183 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/351 • 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).
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.
|
0.55%
1/183 • Number of events 1 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
Other adverse events
| Measure |
Priorix-Tetra + Meningitec Group
n=351 participants at risk
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.
|
Priorix-Tetra Group
n=183 participants at risk
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.
|
Meningitec Group
n=182 participants at risk
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.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
11/351 • Number of events 11 • 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).
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.
|
5.5%
10/183 • Number of events 10 • 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).
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.
|
2.7%
5/182 • Number of events 5 • 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).
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.
|
|
Nervous system disorders
Somnolence
|
42.2%
148/351 • Number of events 148 • 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).
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.
|
48.6%
89/183 • Number of events 89 • 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).
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.
|
30.8%
56/182 • Number of events 56 • 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).
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.
|
|
General disorders
Injection site pain
|
26.2%
92/351 • Number of events 92 • 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).
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.
|
16.9%
31/183 • Number of events 31 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
General disorders
Injection site swelling
|
22.5%
79/351 • Number of events 79 • 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).
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.
|
10.9%
20/183 • Number of events 20 • 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).
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.
|
0.55%
1/182 • Number of events 1 • 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).
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.
|
|
General disorders
Injection site erythema
|
34.5%
121/351 • Number of events 121 • 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).
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.
|
22.4%
41/183 • Number of events 41 • 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).
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.
|
0.00%
0/182 • 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).
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.
|
|
General disorders
Decreased appetite
|
50.7%
178/351 • Number of events 178 • 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).
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.
|
54.1%
99/183 • Number of events 99 • 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).
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.
|
33.0%
60/182 • Number of events 60 • 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).
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.
|
|
General disorders
Irritability postvaccinal
|
53.3%
187/351 • Number of events 187 • 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).
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.
|
56.8%
104/183 • Number of events 104 • 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).
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.
|
46.2%
84/182 • Number of events 84 • 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).
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.
|
|
General disorders
Pyrexia
|
62.7%
220/351 • Number of events 220 • 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).
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.
|
62.3%
114/183 • Number of events 114 • 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).
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.
|
35.2%
64/182 • Number of events 64 • 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).
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.1%
11/351 • Number of events 11 • 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).
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.
|
5.5%
10/183 • Number of events 10 • 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).
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.
|
2.2%
4/182 • Number of events 4 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
91/351 • Number of events 91 • 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).
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.
|
22.4%
41/183 • Number of events 41 • 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).
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.
|
8.2%
15/182 • Number of events 15 • 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).
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.
|
|
Infections and infestations
Pharyngitis
|
4.6%
16/351 • Number of events 16 • 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).
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.
|
5.5%
10/183 • Number of events 10 • 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).
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.
|
4.9%
9/182 • Number of events 9 • 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).
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.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER