Infections, Meningococcal
Conditions
Keywords
Conjugate vaccine, Meningococcal disease, Immunogenicity, Meningococcal vaccine, Safety
Brief summary
The purpose of the study is to investigate whether or not GSK Biologicals' meningococcal vaccine GSK134612 is inferior to a licensed MenC-CRM197 conjugate vaccine in terms of vaccine antibody response against meningococcal serogroup C disease.
Detailed description
The study has 2 study groups. One group will receive one dose of GSK Biologicals' vaccine GSK 134612 and the other group will receive one dose of licensed MenC-CRM197 vaccine. All subjects will have 2 blood samples taken: just before vaccination and one month after vaccination.
Interventions
BIOLOGICALGSK Biologicals' meningococcal vaccine GSK134612
Intramuscular administration, 1 dose
BIOLOGICALMenjugate
Intramuscular administration, 1 dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 2 and 10 years of age at the time of the vaccination. * Written informed consent obtained from the parent(s) or guardian of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the study vaccine dose, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.. * Administration of a vaccine not foreseen by the study protocol during the period starting from one month before the dose of the study vaccine and ending 30 days after. * Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W-135 and/or Y (for subjects below 6 years) or within the last five years (for subjects 6 years old and above). * Previous vaccination with meningococcal polysaccharide conjugate vaccine serogroups A, C, W-135 and/or Y. * History of meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment * Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccine dose or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody | One month after vaccination (Month 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Prior to (Month 0) and one month after vaccination (Month 1) | 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). |
| Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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). |
| Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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). |
| Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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 |
| Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | Prior to (Month 0) and one month after vaccination (Month 1) | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects Reporting Specific Adverse Events | Up to 6 months after vaccination (Month 6) | 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. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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. |
| Number of Subjects With Any Serious Adverse Events (SAEs) | Up to six months after vaccination (Month 6) | 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. |
| Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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 |
Countries
France, Germany
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria,contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 311 |
| 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. | 103 |
| Total | 414 |
Baseline characteristics
| Characteristic | Nimenrix Group | Menjugate Group | Total |
|---|---|---|---|
| Age, Continuous | 5.6 Years STANDARD_DEVIATION 2.52 | 5.6 Years STANDARD_DEVIATION 2.32 | 5.6 Years STANDARD_DEVIATION 2.47 |
| Race/Ethnicity, Customized African heritage/African American | 13 Participants | 6 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-East Asian heritage | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian-Japanese heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-South East Asian heritage | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Not specified | 8 Participants | 2 Participants | 10 Participants |
| Race/Ethnicity, Customized White-Arabic/North African heritage | 16 Participants | 6 Participants | 22 Participants |
| Race/Ethnicity, Customized White-Caucasian/European heritage | 267 Participants | 87 Participants | 354 Participants |
| Sex: Female, Male Female | 163 Participants | 51 Participants | 214 Participants |
| Sex: Female, Male Male | 148 Participants | 52 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 311 | 0 / 103 |
| other Total, other adverse events | 181 / 311 | 63 / 103 |
| serious Total, serious adverse events | 6 / 311 | 1 / 103 |
Outcome results
Primary
Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | 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 |
| Menjugate Group | Number of Subjects With Vaccine Response to Meningococcal Serogroup C Serum Based on a Bactericidal Assay Using Baby Rabbit Complement (rSBA-MenC) Antibody | 88 Participants |
Comparison: To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference \[Nimenrix group minus Menjugate group\] in the percentages of subjects with bactericidal vaccine response to MenC was computed.95% CI: [-5.25, 5.75]
Secondary
Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations
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).
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, Month 0 | 0.2 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, Month 1 | 32.45 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSc, Month 0 | 0.18 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSc, Month 1 | 14.95 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSW-135, Month 0 | 0.17 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSW-135, Month 1 | 6.96 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSY, Month 0 | 0.16 μg/mL |
| Nimenrix Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSY, Month 1 | 14.15 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSY, Month 1 | 0.17 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, Month 0 | 0.22 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSW-135, Month 0 | 0.17 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSA, Month 1 | 0.31 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSY, Month 0 | 0.16 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSc, Month 0 | 0.2 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSW-135, Month 1 | 0.18 μg/mL |
| Menjugate Group | Anti-meningococcal Serogroup Polysaccharides (Anti-PS) Antibody Concentrations | Anti-PSc, Month 1 | 18.07 μg/mL |
Secondary
Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenA, Month 0 | 31.5 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenA, Month 1 | 6236.1 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenC, Month 0 | 22.7 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenC, Month 1 | 2794.8 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenW-135, Month 0 | 83.2 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenW-135, Month 1 | 8549.5 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenY, Month 0 | 153.6 Titers |
| Nimenrix Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenY, Month 1 | 8360.7 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenY, Month 1 | 128.2 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenA, Month 0 | 25.9 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenW-135, Month 0 | 70.2 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenA, Month 1 | 27.2 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenY, Month 0 | 107.4 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenC, Month 0 | 19.4 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenW-135, Month 1 | 87.3 Titers |
| Menjugate Group | Meningococcal Serogroup A (rSBA) Antibody Titers by Serogroup | rSBA-MenC, Month 1 | 5291.6 Titers |
Secondary
Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms
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).
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Pain | 45 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Redness | 57 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 11 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 43 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 7 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 13 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Pain | 15 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 8 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Redness | 21 Participants |
Secondary
Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
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
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 25 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 9 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 1 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 23 Participants |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 16 Participants |
| Nimenrix Group | 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 |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Nimenrix Group | 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 |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 15 Participants |
| Nimenrix Group | 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 |
| Nimenrix Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 9 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 4 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 6 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 6 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 3 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 6 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 1 Participants |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 5 Participants |
| Menjugate Group | 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 |
| Menjugate Group | Number of Subjects Between 2 and 5 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 5 Participants |
Secondary
Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms
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).
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Pain | 65 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Redness | 58 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 9 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 44 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 4 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 15 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Pain | 27 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 5 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any and Grade 3 Solicited Local Symptoms | Any Redness | 19 Participants |
Secondary
Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms
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
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 33 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 4 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 29 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Orally) | 10 Participants |
| Nimenrix Group | 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 |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Orally) | 9 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 22 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 1 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 13 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 30 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 2 Participants |
| Nimenrix Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 24 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 11 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 4 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 4 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 7 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Any Fever (Orally) | 1 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 2 Participants |
| Menjugate Group | 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 |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 3 Participants |
| Menjugate Group | Number of Subjects Between 6 and 10 Years of Age With Any, Grade 3 and Related Solicited General Symptoms | Related Fever (Orally) | 0 Participants |
Secondary
Number of Subjects Reporting Specific Adverse Events
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events | Any Rash(es) | 8 Participants |
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events | Any NOCI(s) | 1 Participants |
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events | Any ER visit(s) | 11 Participants |
| Menjugate Group | Number of Subjects Reporting Specific Adverse Events | Any Rash(es) | 1 Participants |
| Menjugate Group | Number of Subjects Reporting Specific Adverse Events | Any NOCI(s) | 1 Participants |
| Menjugate Group | Number of Subjects Reporting Specific Adverse Events | Any ER visit(s) | 1 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 6 Participants |
| Menjugate Group | Number of Subjects With Any Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 55 Participants |
| Menjugate Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 20 Participants |