Trial Outcomes & Findings for Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children (NCT NCT00674583)
NCT ID: NCT00674583
Last Updated: 2019-11-18
Results Overview
Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
414 participants
Primary outcome timeframe
One month after vaccination (Month 1)
Results posted on
2019-11-18
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 |
Nimenrix Group
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
311
|
103
|
|
Overall Study
COMPLETED
|
311
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children
Baseline characteristics by cohort
| Measure |
Nimenrix Group
n=311 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.6 Years
STANDARD_DEVIATION 2.52 • n=93 Participants
|
5.6 Years
STANDARD_DEVIATION 2.32 • n=4 Participants
|
5.6 Years
STANDARD_DEVIATION 2.47 • n=27 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
214 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian-Central/South Asian heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian heritage
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese heritage
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian-South East Asian heritage
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
16 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
267 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
354 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
8 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Outcome measures
| Measure |
Nimenrix Group
n=268 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=92 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody
|
254 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Nimenrix Group
n=296 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=97 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenA, Month 0
|
31.5 Titers
Interval 23.3 to 42.5
|
25.9 Titers
Interval 15.6 to 43.0
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenA, Month 1
|
6236.1 Titers
Interval 5574.5 to 6976.3
|
27.2 Titers
Interval 15.6 to 47.4
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenC, Month 0
|
22.7 Titers
Interval 18.1 to 28.4
|
19.4 Titers
Interval 13.1 to 28.8
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenC, Month 1
|
2794.8 Titers
Interval 2393.5 to 3263.3
|
5291.6 Titers
Interval 3814.6 to 7340.5
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenW-135, Month 0
|
83.2 Titers
Interval 67.9 to 102.0
|
70.2 Titers
Interval 48.5 to 101.6
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenW-135, Month 1
|
8549.5 Titers
Interval 7618.5 to 9594.3
|
87.3 Titers
Interval 58.5 to 130.4
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenY, Month 0
|
153.6 Titers
Interval 125.3 to 188.3
|
107.4 Titers
Interval 71.4 to 161.6
|
|
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
rSBA-MenY, Month 1
|
8360.7 Titers
Interval 7447.3 to 9386.1
|
128.2 Titers
Interval 83.8 to 196.2
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after vaccination (Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations were presented as geometric mean concentrations (GMCs) and tabulated as micrograms per milliliter (μg/mL).
Outcome measures
| Measure |
Nimenrix Group
n=149 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=52 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSA, Month 0
|
0.2 μg/mL
Interval 0.17 to 0.22
|
0.22 μg/mL
Interval 0.17 to 0.29
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSA, Month 1
|
32.45 μg/mL
Interval 26.57 to 39.63
|
0.31 μg/mL
Interval 0.19 to 0.49
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSc, Month 0
|
0.18 μg/mL
Interval 0.16 to 0.2
|
0.2 μg/mL
Interval 0.16 to 0.25
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSc, Month 1
|
14.95 μg/mL
Interval 12.89 to 17.34
|
18.07 μg/mL
Interval 13.88 to 23.51
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSW-135, Month 0
|
0.17 μg/mL
Interval 0.15 to 0.18
|
0.17 μg/mL
Interval 0.14 to 0.2
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSW-135, Month 1
|
6.96 μg/mL
Interval 5.72 to 8.47
|
0.18 μg/mL
Interval 0.15 to 0.22
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSY, Month 0
|
0.16 μg/mL
Interval 0.15 to 0.17
|
0.16 μg/mL
Interval 0.15 to 0.17
|
|
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
Anti-PSY, Month 1
|
14.15 μg/mL
Interval 11.66 to 17.17
|
0.17 μg/mL
Interval 0.15 to 0.19
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available.
Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 30 millimeters (mm).
Outcome measures
| Measure |
Nimenrix Group
n=162 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=53 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
45 Participants
|
15 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
1 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
57 Participants
|
21 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
11 Participants
|
8 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
43 Participants
|
13 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
7 Participants
|
3 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 vaccinated subjects with their symptom sheets filled in, for whom data were available.
Solicited symptoms assessed were: pain, redness and swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness and Swelling= redness/swelling spreading beyond (\>) 50 millimeters (mm).
Outcome measures
| Measure |
Nimenrix Group
n=148 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=50 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
65 Participants
|
27 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
3 Participants
|
3 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
58 Participants
|
19 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
9 Participants
|
5 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
44 Participants
|
15 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
4 Participants
|
3 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 vaccinated subjects with their symptom sheets filled in, for whom data were available.
Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination
Outcome measures
| Measure |
Nimenrix Group
n=162 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=53 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
23 Participants
|
6 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
1 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
15 Participants
|
6 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
9 Participants
|
3 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
0 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
9 Participants
|
3 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
25 Participants
|
6 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
1 Participants
|
1 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
16 Participants
|
5 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
17 Participants
|
5 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
|
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
9 Participants
|
4 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 vaccinated subjects with their symptom sheets filled in, for whom data were available.
Solicited general symptoms assessed were drowsiness, fever \[defined as oral temperature ≥ 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the general symptom regardless of intensity grade and relationship to vaccination. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Loss of appetite = did not eat at all. Grade 3 Fever = fever \> 39.5°C. Related = general symptoms assessed by the investigator as causally related to vaccination
Outcome measures
| Measure |
Nimenrix Group
n=148 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=50 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
33 Participants
|
11 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
4 Participants
|
0 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
29 Participants
|
7 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (Orally)
|
10 Participants
|
1 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (Orally)
|
0 Participants
|
0 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (Orally)
|
9 Participants
|
0 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal
|
22 Participants
|
4 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal
|
1 Participants
|
0 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal
|
13 Participants
|
3 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
30 Participants
|
4 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
2 Participants
|
0 Participants
|
|
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
24 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after vaccination (Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Specific AEs included: - rash (hives, idiopathic thrombocytopenic purpura, petechiae); - new onset of chronic illness(es) (NOCI) (e.g. autoimmune disorders, asthma, type I diabetes and allergies); - conditions prompting emergency room (ER) visits.
Outcome measures
| Measure |
Nimenrix Group
n=311 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects Reporting Specific Adverse Events
Any Rash(es)
|
8 Participants
|
1 Participants
|
|
Number of Subjects Reporting Specific Adverse Events
Any NOCI(s)
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Specific Adverse Events
Any ER visit(s)
|
11 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Nimenrix Group
n=311 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
55 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to six months after vaccination (Month 6)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Nimenrix Group
n=311 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 Participants
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
6 Participants
|
1 Participants
|
Adverse Events
Nimenrix Group
Serious events: 6 serious events
Other events: 181 other events
Deaths: 0 deaths
Menjugate Group
Serious events: 1 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix Group
n=311 participants at risk
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 participants at risk
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Nervous system disorders
Convulsion
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Appendicitis
|
0.32%
1/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.00%
0/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/311 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
0.97%
1/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
Other adverse events
| Measure |
Nimenrix Group
n=311 participants at risk
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0.
|
Menjugate Group
n=103 participants at risk
Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0.
|
|---|---|---|
|
General disorders
Pain
|
35.5%
110/310 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
40.8%
42/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Redness
|
37.1%
115/310 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
38.8%
40/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Swelling
|
28.1%
87/310 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
27.2%
28/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Drowsiness (< 6 years)
|
14.2%
23/162 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
11.3%
6/53 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Fever
|
6.1%
19/310 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
3.9%
4/103 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Irritability (< 6 years)
|
15.4%
25/162 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
11.3%
6/53 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Loss of appetite (< 6 years)
|
10.5%
17/162 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
9.4%
5/53 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Fatigue (≥ 6 years)
|
22.3%
33/148 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
22.0%
11/50 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Gastrointestinal (≥ 6 years)
|
14.9%
22/148 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
8.0%
4/50 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
|
General disorders
Headache (≥ 6 years)
|
20.3%
30/148 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
8.0%
4/50 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited adverse events (AEs): during the 31-day (Days 0-30) post-vaccination period. Serious adverse events (SAEs): from Day 0 up to Month 6 post-vaccination.
The solicited local and general symptoms were only collected from those subjects who filled in their symptom sheets.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER