Infections, Meningococcal
Conditions
Keywords
Safety, Vaccines, conjugate, Immunogenicity, Meningococcal vaccine, Booster vaccination, Primary vaccination, Neisseria meningitides, Toddlers, Humans, Meningococcal disease
Brief summary
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.
Detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers. The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose or two doses of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 when given to healthy toddlers 9-12 months of age. To evaluate, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination. To evaluate the safety and immunogenicity in a new group of subjects aged 5-6 years (naive control group) who will receive a single dose of vaccine GSK134612.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One dose, as intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria for the persistence phase of the study entry: * A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081. * Written informed consent obtained from parents/guardian of the subject. * Healthy subjects as established by medical history before entering into the study. * Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose). All subjects must meet the following criteria prior to receiving the booster vaccination: * Written informed consent obtained from parents/guardian of the subject. * Subjects who can and will comply with the requirements of the protocol. * Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081. All subjects must satisfy the following criteria prior to enrollment in the naïve control group: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 5-6 years of age at the time of the vaccination. * Written informed consent obtained from parents/guardian of the subject. * Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | At Year 1 (12 months post primary vaccination) | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8. |
| Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | At Year 5 (60 months post primary vaccination) | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | At Year 1 (12 months post primary vaccination) | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. |
| Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | At Year 3 (36 months post primary vaccination) | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. |
| Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | At Year 5 (60 months post-primary vacccination). | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay. |
| Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | At Year 5 (60 months post-primary vacccination) | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay. |
| rSBA Antibody Titers | At Year 1 (12 months post primary vaccination) | Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay. |
| rSBA Antibody Titers. | At Year 3 (36 months post-primary vaccination) | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay. |
| Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | At Year 1 (12 months post primary vaccination) | Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml). |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | At Year 1 (12 months post primary vaccination) | The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group. |
| hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | At Month 60 (pre-vaccination with Nimenrix vaccine) | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | At Year 1 (12 months post vaccination) | hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group. |
| Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups | Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer \< 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups) | The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay. |
| Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups) | Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups | 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 Reporting Any Serious Adverse Events (SAEs) | During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | At Month 60 (pre-primary vaccination with Nimenrix vaccine) | rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group. |
| hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | At Year 1 (12 months post primary vaccination) | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects. |
Countries
United States
Participant flow
Recruitment details
Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects.
Pre-assignment details
Out of 387 subjects originally enrolled in the study, only 248 subjects received vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix 1 Group Y1 Subjects from Year 1 Period who received 1 dose on Nimenrix vaccine at 12 months of age. | 118 |
| Nimenrix 2 Group Y1 Subjects from Year 1 Period who were previously vaccinated with two doses of Nimenrix, one each at 9 and 12 months of age. | 130 |
| Nimenrix Naive Group Vaccine-naive subjects aged 5-6 years were enrolled to receive Nimenrix vaccine as primary vaccination at Year 5. | 100 |
| Total | 348 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Booster Phase Year 5 | Declined v-4 serology | 1 | 0 | 0 |
| Booster Phase Year 5 | Lost to Follow-up | 1 | 0 | 4 |
| Booster Phase Year 5 | No active participation request | 0 | 0 | 1 |
| Booster Phase Year 5 | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Nimenrix 2 Group Y1 | Nimenrix Naive Group | Total | Nimenrix 1 Group Y1 |
|---|---|---|---|---|
| Age, Continuous | 24.6 Months STANDARD_DEVIATION 1 | 69.2 Months STANDARD_DEVIATION 6.6 | 37.38 Months STANDARD_DEVIATION 20.56 | 24.5 Months STANDARD_DEVIATION 0.97 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 7 Participants | 23 Participants | 37 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 16 Participants | 10 Participants | 35 Participants | 9 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-Central/South Asian heritage | 4 Participants | 1 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian heritage | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-South East Asian heritage | 8 Participants | 3 Participants | 18 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or other Pacific Islander | 2 Participants | 3 Participants | 6 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 26 Participants | 13 Participants | 55 Participants | 16 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Caucasian/European heritage | 67 Participants | 46 Participants | 185 Participants | 72 Participants |
| Sex/Gender, Customized Female | 66 Participants | 44 Participants | 166 Participants | 56 Participants |
| Sex/Gender, Customized Male | 64 Participants | 56 Participants | 182 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 46 | 0 / 100 |
| other Total, other adverse events | 31 / 38 | 43 / 46 | 67 / 100 |
| serious Total, serious adverse events | 0 / 38 | 0 / 46 | 1 / 100 |
Outcome results
Primary
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenA, ≥ 1:8 | 21 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenC, ≥ 1:8 | 91 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenW-135, ≥ 1:8 | 93 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenY, ≥ 1:8 | 88 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenY, ≥ 1:8 | 111 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenA, ≥ 1:8 | 28 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenW-135, ≥ 1:8 | 111 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenC, ≥ 1:8 | 103 Participants |
Primary
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.
Time frame: At Year 3 (36 months post primnary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenA, ≥ 1:8 | 14 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenC, ≥ 1:8 | 57 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenW-135, ≥ 1:8 | 54 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenY, ≥ 1:8 | 53 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenY, ≥ 1:8 | 59 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenA, ≥ 1:8 | 16 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenW-135, ≥ 1:8 | 82 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off | hSBA-MenC, ≥ 1:8 | 68 Participants |
Primary
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:8.
Time frame: At Year 5 (60 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:8 | 20 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:8 | 45 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:8 | 40 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:8 | 32 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:8 | 49 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:8 | 27 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:8 | 62 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:8 | 53 Participants |
Secondary
Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations
Results were tabulated as geometric mean antibody concentration (GMC) calculated on all subjects, expressed in microgram per milliliter (μg/ml).
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSA | 0.45 μg/ml |
| Nimenrix 1 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSC | 0.27 μg/ml |
| Nimenrix 1 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSW-135 | 0.96 μg/ml |
| Nimenrix 1 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSY | 1.41 μg/ml |
| Nimenrix 2 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSY | 1.7 μg/ml |
| Nimenrix 2 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSA | 0.33 μg/ml |
| Nimenrix 2 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSW-135 | 1.2 μg/ml |
| Nimenrix 2 Group Y1 | Antibody to Polysacccharide N. Meningitidis Serogroup A, C, W-135 and Y (Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY) Antibody Concentrations | Anti-PSC | 0.25 μg/ml |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
Time frame: At Year 3 (36 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 3.5 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 31.2 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 29 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 22 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 20.5 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 3.4 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 63.9 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 29.8 Titres |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
Time frame: At Year 5 (60 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 4.6 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 40.7 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 24.2 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 26 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 37.9 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 6.6 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 53.7 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 38.2 Titres |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 3.7 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 70.5 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 127.9 Titres |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 55.6 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenY | 86.2 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenA | 4.1 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 204.6 Titres |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Antibody Titers | hSBA-MenC | 72.4 Titres |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBAMenW-135, and hSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.
Time frame: At Month 60 (pre-vaccination with Nimenrix vaccine)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenA | 3.3 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenC | 5.3 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenW-135 | 7 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenY | 9.5 Titers |
Secondary
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers
Titers were given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC,hSBAMenW-135, and hSBA-MenY respectively, calculated on all subjects.
Time frame: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenA | 1395.9 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenC | 8185.7 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenW-135 | 15800.9 Titers |
| Nimenrix 1 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenY | 8809.1 Titers |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenY | 10513.8 Titers |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenA | 1590.1 Titers |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenW-135 | 20495.9 Titers |
| Nimenrix 2 Group Y1 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenC | 12881.2 Titers |
| Nimenrix Naive Group Y5 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenY | 198.7 Titers |
| Nimenrix Naive Group Y5 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenC | 95.3 Titers |
| Nimenrix Naive Group Y5 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenW-135 | 98.1 Titers |
| Nimenrix Naive Group Y5 | hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers | hSBA-MenA | 38.3 Titers |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom
Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Swelling | 8 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Pain | 0 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Swelling | 1 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Redness | 10 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Redness | 1 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Pain | 18 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Pain | 21 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Swelling | 9 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Redness | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Redness | 15 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Swelling | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Pain | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Swelling | 2 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Pain | 46 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Pain | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Grade 3 Redness | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Swelling | 21 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptom | Any Redness | 22 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom
Assessed solicited general symptoms were fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache and gastrointestinal. Any was defined as occurrence of the symptom regardless of their intensity grade or relationship to study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fatigue | 10 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Headache | 4 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Fever (Axillary) >39.5°C | 0 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Fatigue | 0 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fatigue | 8 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fever (Axillary) | 1 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Gastrointestinal | 1 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Gastrointestinal | 4 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Headache | 1 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Headache | 4 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Gastrointestinal | 3 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fever (Axillary) | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Gastrointestinal | 4 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Headache | 5 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fever (Axillary) | 2 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Fatigue | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Fever (Axillary) >39.5°C | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fever (Axillary) | 1 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fatigue | 7 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Headache | 4 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fatigue | 6 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Gastrointestinal | 5 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Gastrointestinal | 2 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Headache | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fever (Axillary) | 3 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Gastrointestinal | 7 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Headache | 11 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Fatigue | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Fatigue | 15 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Gastrointestinal | 0 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Gastrointestinal | 5 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Grade 3 Headache | 1 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Related Headache | 8 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fever (Axillary) | 5 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Fever (Axillary) >39.5°C | 0 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptom | Any Fatigue | 18 Participants |
Secondary
Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the 181-day (Days 0-180) post primary vaccination for Nimenrix Naive Group and post booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Number of Subjects Reporting 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-primary vaccination for Nimenrix Naive Group and post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects in this current study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 9 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 6 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 29 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values
The cut-off values for the assay were ≥ 0.3 μg/ml and ≥ 2.0 μg/ml respectively.
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSA, ≥0.3 μg/ml | 60 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSA, ≥2.0 μg/ml | 12 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSC, ≥0.3 μg/ml | 36 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSC, ≥2.0 μg/ml | 3 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135, ≥0.3 μg/ml | 78 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135, ≥2.0 μg/ml | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSY, ≥0.3 μg/ml | 84 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Row Anti-PSY, ≥2.0 μg/ml | 45 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Row Anti-PSY, ≥2.0 μg/ml | 50 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSA, ≥0.3 μg/ml | 59 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135, ≥0.3 μg/ml | 104 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSA, ≥2.0 μg/ml | 6 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSY, ≥0.3 μg/ml | 114 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSC, ≥0.3 μg/ml | 39 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSW-135, ≥2.0 μg/ml | 29 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY ≥ the Cut-off Values | Anti-PSC, ≥2.0 μg/ml | 4 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:4 or 1:8. This outcome measure only concerns the Nimenrix Naive Group.
Time frame: At Month 60 (pre-primary vaccination with Nimenrix vaccine)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥1:4 | 16 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥1:8 | 16 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC,≥1:4 | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥1:8 | 24 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥1:4 | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥1:8 | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥1:4 | 29 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥1:8 | 29 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:4 or 1:8.
Time frame: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all vaccinated subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:4 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:8 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:4 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:8 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:8 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:4 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:8 | 32 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:4 | 37 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:4 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:8 | 37 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:4 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:8 | 38 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:4 | 68 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:8 | 62 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenA, ≥ 1:4 | 62 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenC, ≥ 1:8 | 66 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:4 | 66 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:8 | 70 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 70 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titers ≥ Cut-off Values | hSBA-MenY, ≥ 1:8 | 66 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
Time frame: At Year 5 (60 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 20 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 47 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 40 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 32 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 49 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 27 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 62 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 56 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
Time frame: At Year 1 (12 months post vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 23 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 91 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 93 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 89 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 111 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 29 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 111 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 103 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was ≥ 1:4.
Time frame: At Year 3 (36 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 14 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 59 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 54 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 53 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY, ≥ 1:4 | 59 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA, ≥ 1:4 | 19 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135, ≥ 1:4 | 82 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC, ≥ 1:4 | 69 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 or 1:128. This outcome measure only concerns the Nimenrix Naive Group.
Time frame: At Month 60 (pre-primary vaccination with Nimenrix vaccine)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenA, ≥ 1:8 | 20 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenA, ≥ 1:128 | 9 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenC, ≥ 1:8 | 5 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenC, ≥ 1:128 | 4 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenW-135, ≥ 1:8 | 3 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenW-135, ≥ 1:128 | 3 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenY, ≥ 1:8 | 23 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers ≥ Cut-off Values | rSBA-MenY, ≥ 1:128 | 23 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values
The cut-off values for the assay were ≥1:8 and ≥1:128. Titers were determined by Public Health England (PHE) laboratory assay.
Time frame: At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster vaccination for Nimenrix 1 and Nimenrix 2 Groups)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:8 | 15 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:128 | 11 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:8 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:128 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:8 | 21 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:128 | 6 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:8 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:128 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:8 | 7 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:128 | 4 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:8 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:128 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:8 | 16 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:128 | 10 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:8 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:128 | 31 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:128 | 12 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:128 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:128 | 12 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:8 | 10 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:128 | 7 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:128 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:8 | 23 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:128 | 14 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:128 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:8 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:128 | 38 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:8 | 18 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:8 | 18 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:8 | 82 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:128 | 4 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:8 | 23 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:8 | 81 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:8 | 80 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:128 | 82 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:8 | 20 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M61 ≥1:128 | 72 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M61 ≥1:128 | 81 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC, M60 ≥1:8 | 5 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:8 | 3 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M60 ≥1:128 | 23 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M60 ≥1:128 | 9 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135, M60 ≥1:128 | 3 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA, M61 ≥1:128 | 81 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBAMenW-135 and rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY, M61 ≥1:8 | 82 Participants |
Secondary
Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
Time frame: At Year 3 (36 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenA, ≥ 1:8 | 65 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenA, ≥ 1:128 | 51 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenC, ≥ 1:8 | 60 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenC, ≥ 1:128 | 32 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenW-135, ≥ 1:8 | 68 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenW-135, ≥ 1:128 | 56 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenY, ≥ 1:8 | 69 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenY, ≥ 1:128 | 62 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenY, ≥ 1:128 | 78 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenA, ≥ 1:8 | 82 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenW-135, ≥ 1:8 | 88 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenA, ≥ 1:128 | 65 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenY, ≥ 1:8 | 89 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenC, ≥ 1:8 | 75 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenW-135, ≥ 1:128 | 69 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for MenA , MenC, MenW-135 and MenY Serum Bactericidal Antibodies, Using Baby Rabbit Complement | rSBA-MenC, ≥ 1:128 | 40 Participants |
Secondary
Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128 determined by Public Health England (PHE) laboratory assay.
Time frame: At Year 5 (60 months post-primary vacccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 38 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 22 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 29 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 16 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 15 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 9 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 33 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 23 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 26 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 42 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 22 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 26 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 36 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 29 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 14 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Men-A , Men-C, Men-W-135 and Men-Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 19 Participants |
Secondary
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. Titers were determined by Public Health England (PHE) laboratory assay.
Time frame: At Year 3 (36 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 38 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 23 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 27 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 18 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 36 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 24 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 39 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 21 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 24 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 44 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 35 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 24 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 45 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 30 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 23 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 15 Participants |
Secondary
Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 90 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 71 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 83 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 46 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 97 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 82 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 96 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 85 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 100 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 101 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 114 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 80 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 113 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 96 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:128 | 89 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 54 Participants |
Secondary
Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay
rSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off values assessed were ≥ 1:8 and 1:128. The analysis was performed by GSK Biologicals' laboratory assay.
Time frame: At Year 5 (60 months post-primary vacccination).
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 51 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 38 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 43 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 23 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 51 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135,≥ 1:128 | 41 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 50 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 43 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:128 | 58 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:8 | 57 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135, ≥ 1:8 | 64 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenA, ≥ 1:128 | 49 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenY, ≥ 1:8 | 64 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:8 | 53 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenW-135,≥ 1:128 | 53 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Titers ≥ the Cut-off, for Meningococcal Polysaccharides A , C, W-135 and Y Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay | rSBA-MenC, ≥ 1:128 | 31 Participants |
Secondary
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Vaccine response was defines as: for initially seronegative subjects (pre-vaccination titer \< 1:4): hSBA post-vaccination antibody titers ≥ 1:8 and for seropositive subjects (pre-vaccination titers ≥ 1:4): hSBA antibody titers at least four times the pre-vaccination antibody titers.
Time frame: At Month 61, one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 31 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY | 26 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY | 31 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA | 35 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 35 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC | 31 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenY | 48 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenC | 48 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenW-135 | 48 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers | hSBA-MenA | 56 Participants |
Secondary
Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers
Vaccine response was defined as: for initially seronegative subjects: antibody titer ≥ 1:32 at post-vaccination; and for initially seropositive subjects: antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. Titers were determined by Public Health England (PHE) laboratory assay.
Time frame: At Month 61 (one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 28 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 26 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 30 Participants |
| Nimenrix 1 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 29 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 36 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 36 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 37 Participants |
| Nimenrix 2 Group Y1 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 32 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 78 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 70 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 77 Participants |
| Nimenrix Naive Group Y5 | Number of Subjects With Vaccine Response With rSBA-MenA, rSBA-MenC, hSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 75 Participants |
Secondary
rSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, determined by Public Health England \[PHE\] laboratory assay.
Time frame: At Month 60 and 61 (just prior to and one month post-primary vaccination for Nimenrix Naive Group; one month post-booster for Nimenrix 1 and Nimenrix 2 Groups)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (Nimenrix Naive Group) or booster vaccination (Nimenrix 1 and Nimenrix 2 Group)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135, M60 | 8.7 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenC, M60 | 16 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135, M61 | 10713.2 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenA, M61 | 5238.1 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenC, M61 | 2738.9 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenY, M60 | 29.2 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenA, M60 | 35.9 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenY, M61 | 5601.6 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenC, M61 | 3605 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenY, M61 | 5098.3 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenC, M60 | 20 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenA, M60 | 35.8 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenA, M61 | 5287.7 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135, M60 | 10 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135, M61 | 11585.2 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenY, M60 | 22 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenW-135, M61 | 5792.6 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenC, M60 | 5.2 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenC, M61 | 525.1 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenW-135, M60 | 4.7 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenA, M61 | 2970.7 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenY, M60 | 16.6 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenY, M61 | 4027.3 Titers |
| Nimenrix Naive Group Y5 | rSBA Antibody Titers | rSBA-MenA, M60 | 8.1 Titers |
Secondary
rSBA Antibody Titers
Titers are given as geometric mean titers (GMTs), calculated on all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively by GSK Biologicals' laboratory assay.
Time frame: At Year 5 (60 months post-primary vacccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 311.6 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 88.6 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 339.4 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 347.6 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 367.7 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 277.5 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 404.2 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 85.5 Titers |
Secondary
rSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.
Time frame: At Year 3 (36 months following primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 18.4 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 13.2 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 19.4 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 19.6 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 16.7 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 16.6 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 14.6 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 10.6 Titers |
Secondary
rSBA Antibody Titers
Titers were given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.
Time frame: At Year 1 (12 months post primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 1, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 259.7 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 94.1 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 385.2 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 364.5 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenY | 342.2 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenA | 237.2 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenW-135 | 345.3 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers | rSBA-MenC | 90.3 Titers |
Secondary
rSBA Antibody Titers.
Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively, as performed by GSK Biologicals' laboratory assay.
Time frame: At Year 3 (36 months post-primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 3, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenC | 87 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenA | 247.9 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenW-135 | 353.3 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenY | 360.5 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenY | 341.4 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenA | 241.8 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenC | 76.4 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenW-135 | 358 Titers |
Secondary
rSBA Antibody Titers.
Titers are given as geometric mean titers (GMTs), calculated for all subjects for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. Titers were determined by Public Health England (PHE) laboratory assay.
Time frame: At Year 5 (60 months following primary vaccination)
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence Year 5, which included all evaluable subjects who were eligible in the primary study 109375, who complied with the protocol requirements and for whom assay results for at least 1 tested antigen were available at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenA | 32.4 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenC | 20 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenW-135 | 8.9 Titers |
| Nimenrix 1 Group Y1 | rSBA Antibody Titers. | rSBA-MenY | 32 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenY | 26.9 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenA | 32.3 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenW-135 | 11.8 Titers |
| Nimenrix 2 Group Y1 | rSBA Antibody Titers. | rSBA-MenC | 16.5 Titers |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups rSBA-MenA, rSBA-MenC, rSBAMenW-135, and rSBA-MenY respectively. This outcome measure only concerns the Nimenrix Naive Group.
Time frame: At Month 60 (pre-primary vaccination with Nimenrix vaccine)
Population: The analysis was performed on the Booster ATP cohort for immunogenicity,which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken before the primary vaccination with Nimenrix, of the Nimenrix Naive Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group Y1 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA | 8.1 Titers |
| Nimenrix 1 Group Y1 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC | 5.2 Titers |
| Nimenrix 1 Group Y1 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135 | 4.7 Titers |
| Nimenrix 1 Group Y1 | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY | 16.6 Titers |