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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003476-35 |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific serum bactericidal activity using human complement (hSBA) of (respectively) serogroup A, C, W-135 and Y at 12 months of age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM and Routine Vaccines (Group 1) | Experimental | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
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| MenACWY-CRM and Routine Vaccines (Group 2) | Experimental | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. |
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| MenACWY-CRM and Routine Vaccines (Group 3) | Experimental | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y | The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y. | 1 month after primary vaccination and immediately before third dose at 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Memory B Cells by Serogroup A, C, W-135 and Y | Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA. |
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Inclusion Criteria:
Subjects who were eligible to be enrolled in the study:
Exclusion Criteria:
Subjects who were not eligible for the study were those:
whose parents had not given or were unwilling or unable to give written informed consent to their child's participation in the study
with known hypersensitivity to any vaccines contained within the routine immunization schedule
with unacceptable concurrent illnesses or conditions - e.g.:
who have received any prohibited prior or concomitant medications - e.g.:
participating in any other clinical trial either currently or in the previous month;
unable to adhere to the protocol, including plans to move from the area;
Other:
Had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine | Headington | Oxford | OX3 7LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23566945 | Result | Blanchard-Rohner G, Snape MD, Kelly DF, O'Connor D, John T, Clutterbuck EA, Ohene-Kena B, Klinger CL, Odrljin T, Pollard AJ. The B-cell response to a primary and booster course of MenACWY-CRM(1)(9)(7) vaccine administered at 2, 4 and 12 months of age. Vaccine. 2013 May 7;31(20):2441-8. doi: 10.1016/j.vaccine.2013.03.036. Epub 2013 Apr 6. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at one study center in the UK.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM and Routine Vaccines (Group 1) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
| FG001 | MenACWY-CRM and Routine Vaccines (Group 2) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. |
| FG002 | MenACWY-CRM and Routine Vaccines (Group 3) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis was done on all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM and Routine Vaccines (Group 1) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Memory B Cells Per 2 x 105 LOC by Serogroup A, C, W-135 and Y | The memory B cell response at one month after primary vaccinations (5 months of age) was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators. Serogroup A, C, W-135 and Y geometric mean titers (GMTs) were measured by serum bactericidal assay using human complement (hSBA) at 12 months of age (before third dose). Correlation and linear regression coefficients were determined between memory B cells at 1 month after primary vaccinations with MenACWY-CRM (5 months of age) and hSBA titers at 12 months of age (before third dose) for the serogroups A, C, W-135 and Y. | Analysis was performed on per-protocol (PP) dataset of primary vaccination, i.e. subjects who received all the relevant doses of vaccine correctly; provided evaluable blood samples at the relevant time points; and had no major protocol violation as defined prior to analysis. | Mean | Standard Deviation | B cells per 2x100000 lymphocytes | 1 month after primary vaccination and immediately before third dose at 12 months of age |
All the serious adverse events were collected throughout the study (day 1 to 18 months).
Other adverse events included solicited local and systemic reactions and non-serious unsolicited adverse events.
Solicited local and systemic reactions were collected from day 1 to day 7 after each vaccination.
Non-serious unsolicited adverse events were collected from 7 days after each vaccination to the next visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MenACWY-CRM and Routine Vaccines (Group 1) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilic colitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C556088 | MenACWY-CRM vaccine |
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| D013745 | Tetanus Toxoid |
| D011054 | Poliovirus Vaccine, Inactivated |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D012411 | Rubella Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| DTaP-Hib-IPV | Biological | IM injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2-, 3-, and 4-months in the anterolateral area of the left thigh. |
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| PCV | Biological | IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left thigh. |
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| MMR | Biological | IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months in the anterolateral area of the left thigh. |
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| Hib | Biological | IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh. |
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| 1 month after primary vaccination and immediately before third dose |
| Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination | Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA. | 1 month after primary vaccination and 1 month after third vaccination |
| Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination | Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA. hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination. The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers. | 1 month after primary and pre-third and 1 month after third vaccination |
| Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y | Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC. Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination. | One month after primary vaccination and 1 week after third vaccination |
| CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination | CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC. CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination. | 5 months (B cells), 12 months and 13 months (B cells and IgG) of age |
| Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC. | Before and one month after booster vaccination |
| Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age. | Before and one month after booster vaccination |
| Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination | The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC. | One month after primary vaccination |
| Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro. The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC. | Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4 |
| Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. | Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4 |
| Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants | The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA. | Day 1 (IgG) and one month after primary vaccination (B cells) |
| Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM | Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. | 1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG) |
| Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months | The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers. Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. | 1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG) |
| Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations. | Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination. | 7 days post each MenACWY-CRM and routine infant vaccination |
| Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations | Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months). | 7 days post vaccination at 2, 3, and 4 months of age |
| Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age | Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age. | 7 days post 12 month vaccination |
| Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age | Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age. | 7 days post 12 months vaccination |
| Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA. | Before and one month after booster vaccination |
| Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. | Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4 |
| Protocol Violation |
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| Unable to Classify |
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| BG001 |
| MenACWY-CRM and Routine Vaccines (Group 2) |
Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. |
| BG002 | MenACWY-CRM and Routine Vaccines (Group 3) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. |
| BG003 | Total | Total of all reporting groups |
| Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Subjects |
|
| ID | Title | Description |
|---|---|---|
| OG000 | MenACWY-CRM and Routine Vaccines (Group 1) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months. |
| OG001 | MenACWY-CRM and Routine Vaccines (Group 2) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. |
| OG002 | MenACWY-CRM and Routine Vaccines (Group 3) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. |
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| Secondary | Memory B Cells by Serogroup A, C, W-135 and Y | Memory B cell response at 1 month after primary vaccination and immediately before third dose at 12 months of age was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations immediately before third dose at 12 months of age were measured by ELISA. | Analysis was performed on PP dataset of persistence population. | Number | 1 month after primary vaccination and immediately before third dose |
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| Secondary | Memory B Cells Per 2x100000 by Serogroup A,C, W-135 and Y at One Month After Primary MenACWY-CRM Vaccination and Third MenACWY-CRM Vaccination | Memory B cell response at 1 month after MenACWY-CRM primary and booster vaccinations was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. hSBA GMTs for the serogroup A, C, W-135 and Y were measured one month after the third MenACWY-CRM vaccination. The meningococcal serogroup A, C, W-135 and Y specific IgG concentrations one month after third MenACWY-CRM vaccination were measured by ELISA. | Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months. Analysis was performed on PP booster population. | Number | 1 month after primary vaccination and 1 month after third vaccination |
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| Secondary | Memory B Cells 1 Month After Primary Vaccination and Rise From Pre-third Dose to 1 Month After Third Dose of MenACWY-CRM Vaccination | Memory B cell response at 1 month after MenACWY-CRM primary and third (booster) vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. The serogroup A, C, W-135 and Y specific IgG concentrations at 1 month after MenACWY-CRM booster were measured by ELISA. hSBA GMTs were measured by hSBA assay one month after MenACWY-CRM booster vaccination. The rise in serogroup specific IgG, memory B cells and hSBA was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x)at 12 months where x is the serogroup specific IgG or memory B cell concentrations or SBA titers. | Values from Group 1 were analyzed separately. Values from Groups 2 and 3 were combined for the analysis. Groups 2 and 3 received PCV at 12 months while Group 1 received PCV at 13 months. Analysis was performed on PP booster population. | Number | 1 month after primary and pre-third and 1 month after third vaccination |
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| Secondary | Memory B Cells 1 Month After Primary Vaccination and 1 Week After Third Vaccination by Serogroup A, C, W-135 and Y | Memory B cell response at 1 month after primary vaccination and at 1 week after third vaccination was measured as mean number of meningococcal serogroup specific memory B cells by ELISpot assay per 2x100000 LOC. Plasma B cell response at 1 week after vaccination was measured as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC. Serogroup A, C, W-135 and Y specific IgG were measured by ELISA and hSBA GMTs were measured at 1 week after third vaccination. | This outcome was assessed in Group 3 subjects only as they provided a blood draw at 1 week following the MenACWY-CRM booster vaccination. Analysis was performed on PP booster population. | Number | One month after primary vaccination and 1 week after third vaccination |
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| Secondary | CRM197 Specific Memory B Cells 1 Month After Primary Vaccination and at 12 Months of Age and One Month After MenACWY-CRM Third Vaccination | CRM197 specific memory B cell response at each time point was measured as mean number of CRM197 specific memory B cells by ELISpot assay per 2x100000 LOC. CRM197 specific IgG concentration was measured by ELISA at 12 months of age and one month after MenACWY-CRM booster vaccination. | Analysis was done on the PP primary population and PP booster population. | Number | 5 months (B cells), 12 months and 13 months (B cells and IgG) of age |
|
|
|
|
| Secondary | Increase in Serogroup A, C, W-135 and Y Specific Memory B Cells Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | Memory B cell response before and one month after MenACWY-CRM booster vaccination at 12 months of age was measured as mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells by ELISpot assay per 2x100000 LOC. | Analysis was performed on the PP dataset of booster vaccination. | Mean | Standard Deviation | B cells per 2x100000 lymphocytes | Before and one month after booster vaccination |
|
|
|
| Secondary | Increase in Serogroup A, C, W-135 and Y Specific hSBA Titers Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | hSBA GMTs were measured before and one month after MenACWY-CRM booster vaccination at 12 months of age. | Analysis was performed on the PP dataset of booster vaccination. | Mean | 95% Confidence Interval | titers | Before and one month after booster vaccination |
|
|
|
| Secondary | Serogroups A, C, W-135 and Y Specific Memory B Cell Response in Children Lacking a hSBA Titer of ≥1:8 One Month After MenACWY-CRM Primary Vaccination | The memory B cell response in children lacking a hSBA titer ≥1:8 one month after MenACWY-CRM primary vaccination was calculated as the mean number of meningococcal serogroup specific memory B cells, measured by ELISpot assay per 2x100000 LOC. | Analysis was performed on the PP primary population and PP persistence population, subjects lacking hSBA ≥1:8 one month after primary vaccination. | Mean | Standard Deviation | B cells per 2x100000 lymphocytes | One month after primary vaccination |
|
|
|
| Secondary | Serogroup A, C, W-135 and Y Specific Memory B Cells and Plasma B Cells After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific memory B cells, plasma B cells and IgG concentrations were measured on days 0, 7, 14, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. The memory B cell response at different timepoint was defined as the mean number of meningococcal serogroup A, C, W-135 and Y specific memory B cells, measured in vitro by ELISpot assay per 2x100000 lymphocytes obtained from culture (LOC) of peripheral blood mononuclear cells (PBMC) circulating in blood incubated for 5.5 days in the presence of polyclonal B cell activators in vitro. The B plasma cell response at each time point was defined as the mean number of cells secreting antibodies specific for meningococcal serogroup A, C, W-135 and Y, measured by ELISpot assay, per 2x100000 PBMC. | This outcome was assessed in Group 1 PP set population. | Mean | Standard Deviation | per 2x100000 cells | Day 0, 7, 14, 49, 90, and 120 after MenACWY-CRM vaccination at month 4 |
|
|
|
| Secondary | Serogroup A, C, W-135 and Y Specific hSBA Titers After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific hSBA titers, the geometric mean titer was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. | This outcome was assessed in Group 1 PP set population. | Geometric Mean | 95% Confidence Interval | titers | Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4 |
|
|
|
| Secondary | Correlation and Linear Regression Coefficients Between Serogroup A, C, W-135 and Y Specific Memory B Cells 1 Month After MenACWY-CRM Primary Vaccination and IgG Concentration at Day 1 in the Serum of Mothers of Infants | The serogroup A, C, W-135 and Y specific IgG concentrations were measured in the serum of mothers at the time of their enrollment into the study (Day 1) by ELISA. | Analysis was performed on the PP primary population. | Number | Day 1 (IgG) and one month after primary vaccination (B cells) |
|
|
|
|
| Secondary | Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and hSBA Titers at 12 Months, (2) Between Serogroup A, C, W-135 and Y Memory B at 5 Months and IgG at 12 Months, After a 2-Dose Primary Course of MenACWY-CRM | Linear regression analysis between memory B cells at 5 months of age and hSBA titers and IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. | Analysis was performed on the PP dataset of persistence population. | Number | 1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG) |
|
|
|
|
| Secondary | Linear Regression Coefficients (1) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in hSBA Titers, (2) Between Serogroup A, C, W-135 and Y Memory B Cells at 5 Months and Rise in IgG, After Third Dose of MenACWY-CRM at 12 Months | The rise in serogroup-specific hSBA and IgG was calculated by pre/post third dose geometric mean ratios, calculated by the difference in the log10 of the concentrations/titers measured at 13 months to the log10 of the concentrations at 12 months: i.e. rise = log10(x) at 13 months minus log10(x) at 12 months where x is the serogroup specific IgG or SBA titers. Linear regression analysis between memory B cells at 5 months of age and rise in hSBA titers or IgG at 12 months of age was performed with and without inclusion of demographic factors (subject's household smoking status, number of older children living in subject's household, attendance at daycare and total duration of breast feeding) in the model. | Analysis was performed on the PP dataset after booster vaccination. | Number | 1 month post primary vaccination (B cells) and 12 months (hSBA titers and IgG) |
|
|
|
|
| Secondary | Percentage of Subjects Who Reported Injection Site Local Reactions After Each MenACWY-CRM and Routine Infant Vaccinations. | Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after each MenACWY-CRM and routine infant vaccination administered as a primary course of vaccination. | The analysis was performed on the Safety Population. | Number | Percentage of subjects | 7 days post each MenACWY-CRM and routine infant vaccination |
|
|
|
| Secondary | Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and Routine Infants Primary Vaccinations | Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM (2 and 4 months) and routine infant primary vaccinations (2, 3 and 4 months). | The analysis was performed on the safety population. | Number | Percentage of subjects | 7 days post vaccination at 2, 3, and 4 months of age |
|
|
|
| Secondary | Percentage of Subjects Who Reported Injection Site Local Reactions After MenACWY-CRM and PCV Vaccinations at 12 Months of Age | Safety was assessed as the percentage of subjects who reported injection site local reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccinations at 12 months of age. | The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age). | Number | Percentage of subjects | 7 days post 12 month vaccination |
|
|
|
| Secondary | Percentage of Subjects Who Reported Solicited Systemic Reactions After MenACWY-CRM and PCV Vaccination at 12 Months of Age | Safety was assessed as the percentage of subjects who reported systemic reactions during 7-day follow-up period after MenACWY-CRM and PCV vaccination at 12 months of age. | The analysis was performed on safety after booster population (safety population who received vaccination at 12 months of age). | Number | Percentage of subjects | 7 days post 12 months vaccination |
|
|
|
| Secondary | Increase in Serogroup A, C, W-135 and Y Specific IgG Concentrations Before and 1 Month After MenACWY-CRM Booster Vaccination at 12 Months of Age Administered Concomitantly With Pneumococcal Conjugate Vaccine or Alone | Serogroup A, C, W-135 and Y specific IgG concentrations were measured before and one month after MenACWY-CRM booster vaccination by ELISA. | Analysis was performed on the PP dataset of booster vaccination. | Mean | 95% Confidence Interval | µg/mL | Before and one month after booster vaccination |
|
|
|
| Secondary | Serogroup A, C, W-135 and Y Specific IgG Concentrations After MenACWY-CRM Primary Vaccination | To assess the kinetics of serogroup A, C, W-135 and Y specific IgG concentrations, the geometric mean concentration was measured on day 0, 7, 14, 30, 49, 90, and 120 following vaccination with MenACWY-CRM vaccination at month 4 of the study. | This outcome was assessed in Group 1 PP set population. | Geometric Mean | 95% Confidence Interval | µg/mL | Day 0, 7, 14, 30, 49, 90,120 after MenACWY-CRM vaccination at month 4 |
|
|
|
| 7 |
| 108 |
| 108 |
| 108 |
| EG001 | MenACWY-CRM and Routine Vaccines (Group 2) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months. This group had an additional blood draw at the time of enrollment. | 4 | 54 | 54 | 54 |
| EG002 | MenACWY-CRM and Routine Vaccines (Group 3) | Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age. This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM. | 6 | 54 | 54 | 54 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Erythema | General disorders | MedDRA | Systematic Assessment |
|
| Induration | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
the terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D007239 | Infections |
| D015164 |
| Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C |
| Parametric correlation |
| 0.37 |
Values from Group 1, 2 and 3 were combined for this analysis. |
| Pearson correlation coefficient |
| -0.13 |
| 95 |
| No |
| Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135 | Parametric correlation | <0.0001 | Values from Group 1, 2 and 3 were combined for this analysis. | Pearson correlation coefficient | 0.66 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y | Parametric correlation | <0.0001 | Values from Group 1, 2 and 3 were combined for this analysis. | Pearson correlation coefficient | 0.90 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A | Non-parametric correlation | 0.94 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.01 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C | Non-parametric correlation | 0.70 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | -0.05 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135 | Non-parametric correlation | 0.04 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.30 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y | Non-parametric correlation | 0.004 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.46 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.005 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135 | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.43 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.82 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A | Parametric correlation | 0.68 | Values from Group 1, 2 and 2 were combined for this analysis. | Pearson correlation coefficient | 0.05 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C | Parametric correlation | 0.46 | Values from Group 1, 2 and 3 were combined for this analysis. | Pearson correlation coefficient | 0.08 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Parametric correlation | 0.08 | Values from Group 1, 2 and 3 were combined for this analysis. | Pearson correlation coefficient | 0.20 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Parametric correlation | <0.001 | Values from Group 1, 2 and 3 were combined for this analysis. | Pearson correlation coefficient | 0.45 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A | Non-parametric correlation | 0.75 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | -0.04 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C | Non-parametric correlation | 0.27 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.11 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Non-parametric correlation | 0.07 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.20 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Non-parametric correlation | 0.06 | Values from Group 1, 2 and 3 were combined for this analysis. | Spearman correlation coefficient | 0.23 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.0029 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.0059 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.04 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Regression, Linear | Values from Group 1, 2 and 3 were combined for this analysis. | R-square | 0.21 | 95 | No | Superiority or Other |
| Parametric correlation |
| 0.59 |
| Pearson correlation coefficient |
| -0.14 |
| 95 |
Values from Group 2 and 3 were combined for this analysis. |
| No |
| Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Parametric correlation | 0.98 | Pearson correlation coefficient | 0.006 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Parametric correlation | 0.20 | Pearson correlation coefficient | 0.24 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.08 | Pearson correlation coefficient | 0.43 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.68 | Pearson correlation coefficient | -0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Parametric correlation | 0.006 | Pearson correlation coefficient | 0.77 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Parametric correlation | 0.48 | Pearson correlation coefficient | 0.16 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.46 | Spearman correlation coefficient | -0.26 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.40 | Spearman correlation coefficient | -0.21 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.60 | Spearman correlation coefficient | 0.12 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.03 | Spearman correlation coefficient | 0.40 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.001 | Spearman correlation coefficient | 0.72 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 1.00 | Spearman correlation coefficient | 0.000 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.24 | Spearman correlation coefficient | 0.39 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.34 | Spearman correlation coefficient | 0.22 | 95 | Values from Group 2 and 3 were combined for the analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.07 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.000 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.06 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.19 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.007 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.59 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.03 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Parametric correlation | 0.0002 | Pearson correlation coefficient | 0.77 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Parametric correlation | 0.90 | Pearson correlation coefficient | 0.03 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Parametric correlation | 0.02 | Pearson correlation coefficient | 0.47 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Parametric correlation | 0.12 | Pearson correlation coefficient | 0.29 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.22 | Pearson correlation coefficient | 0.31 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Parametric correlation | <0.0001 | Pearson correlation coefficient | 0.81 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Parametric correlation | 0.82 | Pearson correlation coefficient | 0.15 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Parametric correlation | 0.66 | Pearson correlation coefficient | -0.15 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.03 | Spearman correlation coefficient | 0.51 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.53 | Spearman correlation coefficient | 0.14 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.35 | Spearman correlation coefficient | 0.20 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.09 | Spearman correlation coefficient | 0.47 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.04 | Spearman correlation coefficient | 0.51 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.10 | Spearman correlation coefficient | 0.35 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.56 | Spearman correlation coefficient | 0.35 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.84 | Spearman correlation coefficient | -0.07 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.59 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.001 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.22 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.10 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.66 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Parametric correlation | 0.08 | Pearson correlation coefficient | 0.29 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Parametric correlation | 0.74 | Pearson correlation coefficient | 0.05 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Parametric correlation | 0.94 | Pearson correlation coefficient | -0.01 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Parametric correlation | 0.51 | Pearson correlation coefficient | -0.09 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.12 | Pearson correlation coefficient | 0.27 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.09 | Pearson correlation coefficient | 0.25 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Parametric correlation | 0.81 | Pearson correlation coefficient | -0.05 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Parametric correlation | 0.07 | Pearson correlation coefficient | 0.28 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.02 | Spearman correlation coefficient | 0.36 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.59 | Spearman correlation coefficient | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.51 | Spearman correlation coefficient | -0.1 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.9 | Spearman correlation coefficient | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.02 | Spearman correlation coefficient | 0.39 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.20 | Spearman correlation coefficient | 0.19 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.34 | Spearman correlation coefficient | 0.18 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.04 | Spearman correlation coefficient | 0.33 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.08 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.0027 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.0002 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.0077 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.07 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.06 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.0023 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A
| Parametric correlation |
| 0.68 |
| Pearson correlation coefficient |
| -0.12 |
| 95 |
Values from Group 2 and 3 were combined for this analysis. |
| No |
| Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Parametric correlation | 0.12 | Pearson correlation coefficient | 0.36 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Parametric correlation | 0.26 | Pearson correlation coefficient | 0.22 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.08 | Pearson correlation coefficient | 0.43 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.42 | Pearson correlation coefficient | -0.17 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Parametric correlation | 0.02 | Pearson correlation coefficient | 0.77 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Parametric correlation | 0.65 | Pearson correlation coefficient | -0.12 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.58 | Spearman correlation coefficient | -0.25 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A | Non-parametric correlation | -0.51 | Spearman correlation coefficient | -0.19 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.24 | Spearman correlation coefficient | 0.28 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.06 | Spearman correlation coefficient | 0.36 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.001 | Spearman correlation coefficient | 0.72 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.12 | Spearman correlation coefficient | -0.32 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.18 | Spearman correlation coefficient | 0.49 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.34 | Spearman correlation coefficient | -0.25 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.06 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.01 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.13 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.05 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.19 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.03 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.60 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.01 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Parametric correlation | 0.001 | Pearson correlation coefficient | 0.83 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Parametric correlation | 0.57 | Pearson correlation coefficient | 0.14 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Parametric correlation | 0.001 | Pearson correlation coefficient | 0.65 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Parametric correlation | 0.11 | Pearson correlation coefficient | 0.31 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.94 | Pearson correlation coefficient | -0.02 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Parametric correlation | 1.00 | Pearson correlation coefficient | -0.0003 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Parametric correlation | 1.00 | Pearson correlation coefficient | 0.004 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Parametric correlation | 0.37 | Pearson correlation coefficient | -0.30 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.09 | Spearman correlation coefficient | 0.52 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.40 | Spearman correlation coefficient | 0.21 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.20 | Spearman correlation coefficient | 0.28 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.03 | Spearman correlation coefficient | 0.41 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.07 | Spearman correlation coefficient | 0.48 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.30 | Spearman correlation coefficient | 0.22 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.74 | Spearman correlation coefficient | 0.26 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.25 | Spearman correlation coefficient | -0.378 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.69 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.42 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.10 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.0004 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.00 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.000 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.90 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Parametric correlation | 0.86 | Pearson correlation coefficient | -0.04 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Parametric correlation | 0.7 | Pearson correlation coefficient | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Parametric correlation | 0.58 | Pearson correlation coefficient | -0.11 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Parametric correlation | 0.44 | Pearson correlation coefficient | -0.13 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.75 | Pearson correlation coefficient | -0.07 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Parametric correlation | 0.84 | Pearson correlation coefficient | -0.04 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Parametric correlation | 0.67 | Pearson correlation coefficient | -0.11 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Parametric correlation | 0.99 | Pearson correlation coefficient | -0.002 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.62 | Spearman correlation coefficient | 0.11 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Non-parametric correlation | 0.36 | Spearman correlation coefficient | 0.17 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.99 | Spearman correlation coefficient | -0.003 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Non-parametric correlation | 0.24 | Spearman correlation coefficient | -0.20 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.62 | Spearman correlation coefficient | 0.11 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.69 | Spearman correlation coefficient | 0.08 | 95 | Values from Group 2 and 3 were combined for the analysis. | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.60 | Spearman correlation coefficient | -0.13 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Non-parametric correlation | 0.95 | Spearman correlation coefficient | -0.01 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.0015 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.0057 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.02 | 95 | Values from Groups 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.0048 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.0018 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.0000 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Parametric correlation |
| 0.09 |
| Pearson correlation coefficient |
| 0.44 |
| 95 |
| No |
| Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135 | Parametric correlation | 0.69 | Pearson correlation coefficient | 0.11 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y | Parametric correlation | 0.20 | Pearson correlation coefficient | 0.38 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A | Non-parametric correlation | 0.88 | Spearman correlation coefficient | -0.05 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C | Non-parametric correlation | 0.12 | Spearman correlation coefficient | 0.41 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.37 | Spearman correlation coefficient | 0.25 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y | Non-parametric correlation | 0.36 | Spearman correlation coefficient | 0.28 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.20 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.15 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C | Parametric correlation | Pearson correlation coefficient | 1.0 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C | Non-parametric correlation | Spearman correlation coefficient | 1.0 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C | Regression, Linear | R-square | 1.0 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.0 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.0 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A | Parametric correlation | 0.79 | Pearson correlation coefficient | -0.08 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C | Parametric correlation | 0.16 | Pearson correlation coefficient | 0.35 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135 | Parametric correlation | 0.10 | Pearson correlation coefficient | 0.48 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y | Parametric correlation | 0.003 | Pearson correlation coefficient | 0.98 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A | Non-parametric correlation | 0.91 | Spearman correlation coefficient | -0.03 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C | Non-parametric correlation | 0.01 | Spearman correlation coefficient | 0.57 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.19 | Spearman correlation coefficient | 0.39 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y | Non-parametric correlation | 0.04 | Spearman correlation coefficient | 0.89 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.12 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.23 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.96 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A | Parametric correlation | 0.46 | Pearson correlation coefficient | 0.18 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C | Parametric correlation | 0.90 | Pearson correlation coefficient | -0.03 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135 | Parametric correlation | 0.008 | Pearson correlation coefficient | 0.51 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y | Parametric correlation | 0.08 | Pearson correlation coefficient | 0.42 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A | Non-parametric correlation | 0.52 | Spearman correlation coefficient | 0.15 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C | Non-parametric correlation | 0.18 | Spearman correlation coefficient | 0.27 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135 | Non-parametric correlation | 0.07 | Spearman correlation coefficient | 0.37 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y | Non-parametric correlation | 0.55 | Spearman correlation coefficient | 0.14 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A | Regression, Linear | R-square | 0.03 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C | Regression, Linear | R-square | 0.0007 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135 | Regression, Linear | R-square | 0.27 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y | Regression, Linear | R-square | 0.17 | 95 | No | Superiority or Other |
Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age |
| Non-parametric correlation |
| 0.0021 |
| Spearman correlation coefficient |
| 0.41 |
| 95 |
Values from Group 1, 2 and 3 were combined for this analysis. |
| No |
| Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age | Regression, Linear | R-square | 0.21 | 95 | Values from Group 1, 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination | Parametric correlation | 0.53 | Pearson correlation coefficient | -0.15 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination | Parametric correlation | 0.26 | Pearson correlation coefficient | 0.21 | 95 | Values from Groups 1, 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination | Non-parametric correlation | 0.84 | Spearman correlation coefficient | -0.05 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination | Non-parametric correlation | 0.26 | Spearman Correlation Coefficient | 0.22 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination | Regression, Linear | R-square | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination | Regression, Linear | R-square | 0.05 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age | Parametric correlation | <0.001 | Pearson correlation coefficient | 0.33 | 95 | Values from Group 1, 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age | Non-parametric correlation | <0.001 | Spearman correlation coefficient | 0.46 | 95 | Values from Group 1, 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age | Regression, Linear | <0.001 | R-square | 0.11 | 95 | Values from Group 1, 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Parametric correlation | 0.06 | Pearson correlation coefficient | 0.24 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Parametric correlation | <0.001 | Pearson correlation coefficient | 0.50 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Non-parametric correlation | 0.01 | Spearman correlation coefficient | 0.31 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Non-parametric correlation | 0.10 | Spearman correlation coefficient | 0.20 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Regression, Linear | R-square | 0.06 | 95 | No | Superiority or Other |
| Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination | Regression, Linear | R-square | 0.25 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
|
| Serogroup C specific B cells (N=75,35,38) before |
|
| Serogroup C specific B cells (N=73,37,40) after |
|
| Serogroup W specific B cells (N=75,34,38) before |
|
| Serogroup W specific B cells (N=73,37,39) after |
|
| Serogroup Y specific B cells (N=67,33,34) before |
|
| Serogroup Y specific B cells (N=64,32,34) after |
|
|
| Serogroup C - hSBA GMT (N=83,39,40)- before |
|
| Serogroup C - hSBA GMT (N=78,39,40)- after |
|
| Serogroup W - hSBA GMT (N=67,37,34)- before |
|
| Serogroup W - hSBA GMT (N=67,37,34)- after |
|
| Serogroup Y - hSBA GMT (N=43,25,16)- before |
|
| Serogroup Y - hSBA GMT (N=32,20,15)- after |
|
|
| Serogroup W-135 specific memory B cells (N=3,0,1) |
|
| Serogroup Y specific memory B cells (N=0,1,1) |
|
|
| Serogroup A sp. memory B cell (N=10)- Day 49 |
|
| Serogroup A sp. memory B cell (N=9)- Day 90 |
|
| Serogroup A sp. memory B cell (N=11)- Day 120 |
|
| Serogroup C sp. memory B cell (N=6)- Day 0 |
|
| Serogroup C sp. memory B cell (N=16)- Day 7 |
|
| Serogroup C sp. memory B cell (N=12)- Day 14 |
|
| Serogroup C sp. memory B cell (N=13)- Day 49 |
|
| Serogroup C sp. memory B cell (N=16)- Day 90 |
|
| Serogroup C sp. memory B cell (N=14)- Day 120 |
|
| Serogroup W-135 sp. memory B cell (N=4)- Day 0 |
|
| Serogroup W-135 sp. memory B cell (N=15)- Day 7 |
|
| Serogroup W-135 sp. memory B cell (N=12)- Day 14 |
|
| Serogroup W-135 sp. memory B cell (N=13)- Day 49 |
|
| Serogroup W-135 sp. memory B cell (N=14)- Day 90 |
|
| Serogroup W-135 sp. memory B cell (N=14)- Day 120 |
|
| Serogroup Y sp. memory B cell (N=3)- Day 0 |
|
| Serogroup Y sp. memory B cell (N=15)- Day 7 |
|
| Serogroup Y sp. memory B cell (N=7)- Day 14 |
|
| Serogroup Y sp. memory B cell (N=11)- Day 49 |
|
| Serogroup Y sp. memory B cell (N=12)- Day 90 |
|
| Serogroup Y sp. memory B cell (N=13)- Day 120 |
|
| Serogroup A sp. plasma B cell (N=3)- Day 0 |
|
| Serogroup A sp. plasma B cell (N=1)- Day 7 |
|
| Serogroup A sp. plasma B cell (N=1)- Day 14 |
|
| Serogroup A sp. plasma B cell (N=2)- Day 49 |
|
| Serogroup A sp. plasma B cell (N=2)- Day 90 |
|
| Serogroup A sp. plasma B cell (N=2)- Day 120 |
|
| Serogroup C sp. plasma B cell (N=3)- Day 0 |
|
| Serogroup C sp. plasma B cell (N=2)- Day 7 |
|
| Serogroup C sp. plasma B cell (N=1)- Day 14 |
|
| Serogroup C sp. plasma B cell (N=2)- Day 49 |
|
| Serogroup C sp. plasma B cell (N=2)- Day 90 |
|
| Serogroup C sp. plasma B cell (N=3)- Day 120 |
|
| Serogroup W-135 sp. plasma B cell (N=3)- Day 0 |
|
| Serogroup W-135 sp. plasma B cell (N=1)- Day 7 |
|
| Serogroup W-135 sp. plasma B cell (N=1)- Day 14 |
|
| Serogroup W-135 sp. plasma B cell (N=2)- Day 49 |
|
| Serogroup W-135 sp. plasma B cell (N=2)- Day 90 |
|
| Serogroup W-135 sp. plasma B cell (N=3)- Day 120 |
|
| Serogroup Y sp. plasma B cell (N=3)- Day 0 |
|
| Serogroup Y sp. plasma B cell (N=1)- Day 7 |
|
| Serogroup Y sp. plasma B cell (N=1)- Day 14 |
|
| Serogroup Y sp. plasma B cell (N=2)- Day 49 |
|
| Serogroup Y sp. plasma B cell (N=2)- Day 90 |
|
| Serogroup Y sp. plasma B cell (N=2)- Day 120 |
|
|
| Serogroup A - hSBA GMTs - Day 30 |
|
| Serogroup A - hSBA GMTs (N=16)- Day 49 |
|
| Serogroup A - hSBA GMTs (N=18)- Day 90 |
|
| Serogroup A - hSBA GMTs (N=16)- Day 120 |
|
| Serogroup C - hSBA GMTs (N=5)- Day 0 |
|
| Serogroup C - hSBA GMTs (N=16)- Day 7 |
|
| Serogroup C - hSBA GMTs (N=12)- Day 14 |
|
| Serogroup C - hSBA GMTs (N=31)- Day 30 |
|
| Serogroup C - hSBA GMTs (N=16)- Day 49 |
|
| Serogroup C - hSBA GMTs (N=18)- Day 90 |
|
| Serogroup C - hSBA GMTs (N=16)- Day 120 |
|
| Serogroup W-135 - hSBA GMTs (N=5)- Day 0 |
|
| Serogroup W-135 - hSBA GMTs (N=12)- Day 7 |
|
| Serogroup W-135 - hSBA GMTs (N=9)- Day 14 |
|
| Serogroup W-135 - hSBA GMTs (N=61)- Day 30 |
|
| Serogroup W-135 - hSBA GMTs (N=11)- Day 49 |
|
| Serogroup W-135 - hSBA GMTs (N=15)- Day 90 |
|
| Serogroup W-135 - hSBA GMTs (N=4)- Day 120 |
|
| Serogroup Y - hSBA GMTs (N=1)- Day 0 |
|
| Serogroup Y - hSBA GMTs (N=8)- Day 7 |
|
| Serogroup Y - hSBA GMTs (N=4)- Day 14 |
|
| Serogroup Y - hSBA GMTs (N=20)- Day 30 |
|
| Serogroup Y - hSBA GMTs (N=8)- Day 49 |
|
| Serogroup Y - hSBA GMTs (N=9)- Day 90 |
|
| Serogroup Y - hSBA GMTs (N=8)- Day 120 |
|
Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C
| Parametric correlation |
| 0.63 |
| Pearson correlation coefficient |
| -0.04 |
| 95 |
| No |
| Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135 | Parametric correlation | 0.74 | Pearson correlation coefficient | -0.03 | 95 | No | Superiority or Other |
| Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y | Parametric correlation | 0.74 | Pearson correlation coefficient | -0.03 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A | Non-parametric correlation | 0.05 | Spearman correlation coefficient | 0.18 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C | Non-parametric correlation | 0.36 | Spearman correlation coefficient | -0.07 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135 | Non-parametric correlation | 0.18 | Spearman correlation coefficient | -0.11 | 95 | No | Superiority or Other |
| Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y | Non-parametric correlation | 0.82 | Spearman correlation coefficient | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A | Regression, Linear | R-square | 0.0013 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C | Regression, Linear | R-square | 0.0014 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135 | Regression, Linear | R-square | 0.0008 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y | Regression, Linear | R-square | 0.0009 | 95 | No | Superiority or Other |
| Regression, Linear |
| R-square |
| 0.14 |
| 95 |
Values from Group 2 and 3 were combined for this analysis. |
| No |
| Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C | Regression, Linear | R-square | 0.09 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.16 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.22 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.33 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.74 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.53 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.37 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.14 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.13 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.17 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.9 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.78 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.94 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.85 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.03 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.0070 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.04 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.02 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.13 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.28 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.3 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A | Regression, Linear | R-square | 0.1 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.11 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C | Regression, Linear | R-square | 0.06 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.17 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135 | Regression, Linear | R-square | 0.21 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.39 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y | Regression, Linear | R-square | 0.33 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Regression, Linear |
| R-square |
| 0.19 |
| 95 |
Values from Group 2 and 3 were combined for this analysis. |
| No |
| Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.52 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.07 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 1 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 0.29 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.19 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.05 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.7 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.21 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.5 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.16 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 1 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 0.3 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.21 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.12 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.0015 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.0057 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.02 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 0.0048 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 0.0018 | 95 | Values from Groups 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.01 | 95 | No | Superiority or Other |
| Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.0000 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.27 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A | Regression, Linear | R-square | 0.19 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.08 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C | Regression, Linear | R-square | 0.08 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135 | Regression, Linear | 0.0436 | R-square | 0.45 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135 | Regression, Linear | R-square | 0.17 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.37 | 95 | No | Superiority or Other |
| Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y | Regression, Linear | R-square | 0.07 | 95 | Values from Group 2 and 3 were combined for this analysis. | No | Superiority or Other |
|
| Erythema - MenACWY-CRM (Vaccination 1) |
|
| Erythema - MenACWY-CRM (Vaccination 2) |
|
| Induration - MenACWY-CRM (Vaccination 1) |
|
| Induration - MenACWY-CRM (Vaccination 2) |
|
| Tenderness - DTaP-IPV-Hib (Vaccination 1) |
|
| Tenderness - DTaP-IPV-Hib (Vaccination 2) |
|
| Tenderness - DTaP-IPV-Hib (Vaccination 3) |
|
| Erythema - DTaP-IPV-Hib (Vaccination 1) |
|
| Erythema - DTaP-IPV-Hib (Vaccination 2) |
|
| Erythema - DTaP-IPV-Hib (Vaccination 3) |
|
| Induration - DTaP-IPV-Hib (Vaccination 1) |
|
| Induration - DTaP-IPV-Hib (Vaccination 2) |
|
| Induration - DTaP-IPV-Hib (Vaccination 3) |
|
| Tenderness - PCV (Vaccination 1) |
|
| Tenderness - PCV (Vaccination 2) |
|
| Erythema - PCV (Vaccination 1) |
|
| Erythema - PCV (Vaccination 2) |
|
| Induration - PCV (Vaccination 1) |
|
| Induration - PCV (Vaccination 2) |
|
|
| Change in eat. habits (N=106,54,53)- Vaccination 3 |
|
| Sleepiness (Vaccination 1) |
|
| Sleepiness (Vaccination 2) |
|
| Sleepiness (Vaccination 3) |
|
| Vomiting (Vaccination 1) |
|
| Vomiting (Vaccination 2) |
|
| Vomiting (Vaccination 3) |
|
| Diarrhea (Vaccination 1) |
|
| Diarrhea (Vaccination 2) |
|
| Diarrhea (Vaccination 3) |
|
| Irritability (Vaccination 1) |
|
| Irritability (Vaccination 2) |
|
| Irritability (Vaccination 3) |
|
| Unusual crying (Vaccination 1) |
|
| Unusual crying (Vaccination 2) |
|
| Unusual crying (Vaccination 3) |
|
| Fever (≥38 °C) - Vaccination 1 |
|
| Fever (≥38 °C) - Vaccination 2 |
|
| Fever (≥38 °C) - Vaccination 3 |
|
| Analg. Antipyr. Med. Used (Vaccination 1) |
|
| Analg. Antipyr. Med. Used (Vaccination 2) |
|
| Analg. Antipyr. Med. Used (Vaccination 3) |
|
|
| Induration - MenACWY-CRM |
|
| Tenderness - PCV |
|
| Erythema - PCV |
|
| Induration - PCV |
|
|
| Vomiting |
|
| Diarrhea |
|
| Irritability |
|
| Unusual crying |
|
| Fever (≥38 °C) |
|
| Analgesics Antipyretics Medicine Used |
|
| Serogroup A specific IgG (N=66,34,38) after |
|
| Serogroup C specific IgG (N=55,25,26) before |
|
| Serogroup C specific IgG (N=59,33,37) after |
|
| Serogroup W specific IgG (N=55,21,26) before |
|
| Serogroup W specific IgG (N=56,32,32) after |
|
| Serogroup Y specific IgG (N=49,21,24) before |
|
| Serogroup Y specific IgG (N=56,31,33) after |
|
|
| Serogroup A specific IgG (N=45)- Day 30 |
|
| Serogroup A specific IgG (N=5)- Day 49 |
|
| Serogroup A specific IgG (N=5)- Day 90 |
|
| Serogroup A specific IgG (N=1)- Day 120 |
|
| Serogroup C specific IgG (N=4)- Day 0 |
|
| Serogroup C specific IgG (N=14)- Day 7 |
|
| Serogroup C specific IgG (N=8)- Day 14 |
|
| Serogroup C specific IgG (N=60)- Day 30 |
|
| Serogroup C specific IgG (N=5)- Day 49 |
|
| Serogroup C specific IgG (N=7)- Day 90 |
|
| Serogroup C specific IgG (N=5)- Day 120 |
|
| Serogroup W-135 specific IgG (N=3)- Day 0 |
|
| Serogroup W-135 specific IgG (N=10)- Day 7 |
|
| Serogroup W-135 specific IgG (N=8)- Day 14 |
|
| Serogroup W-135 specific IgG (N=39)- Day 30 |
|
| Serogroup W-135 specific IgG (N=6)- Day 49 |
|
| Serogroup W-135 specific IgG (N=9)- Day 90 |
|
| Serogroup W-135 specific IgG (N=2)- Day 120 |
|
| Serogroup Y specific IgG (N=3)- Day 0 |
|
| Serogroup Y specific IgG (N=4)- Day 7 |
|
| Serogroup Y specific IgG (N=3)- Day 14 |
|
| Serogroup Y specific IgG (N=33)- Day 30 |
|
| Serogroup Y specific IgG (N=3)- Day 49 |
|
| Serogroup Y specific IgG (N=2)- Day 90 |
|