Co-administration of Meningococcal Vaccine GSK134612 and... | NCT00758264

NCT00758264

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.	Biological: Meningococcal vaccine GSK134612 Biological: Pneumococcal vaccine GSK1024850A
Group B	Active Comparator	Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.	Biological: Meningococcal vaccine GSK134612 Biological: Pneumococcal vaccine GSK1024850A
Group C	Active Comparator	Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.	Biological: Meningococcal vaccine GSK134612 Biological: Pneumococcal vaccine GSK1024850A

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal vaccine GSK134612	Biological	Single dose intramuscular injection.	Group A Group B Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-pneumococcal Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).	At Month 1
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.	At Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.	At Month 1

Secondary Outcomes

Measure	Description	Time Frame
Anti-pneumococcal Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Previous vaccination with a meningococcal vaccine.
Previous administration of a fourth dose of a pneumococcal vaccine
Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
History of meningococcal or pneumococcal invasive disease.
History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mexico City		14000	Mexico
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Huang LM et al. Immunogenicity and safety of PHiD-CV coadministered with a candidate meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in children previously primed with PHiD. Abstract presented at the 5th Asian Congress of Pediatric Infectious Diseases (ACPID). Taipei, Taiwan, 23-26 September 2010.
23076383	Background	Ruiz-Palacios GM, Huang LM, Lin TY, Hernandez L, Guerrero ML, Villalobos AL, Van der Wielen M, Moreira M, Fissette L, Borys D, Miller JM. Immunogenicity and safety of a booster dose of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers: a randomized trial. Pediatr Infect Dis J. 2013 Jan;32(1):62-71. doi: 10.1097/INF.0b013e3182784143.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
111393	Dataset Specification	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

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Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
BG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
BG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

Title	Measurements
	BG00017.2± 1.97 BG00117.2± 1.88 BG00217.4± 1.86 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00083 BG00156 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Hispanic

Title	Measurements
	BG00091 BG00146 BG002

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

Anti-pneumococcal Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

At Month 1

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Units	Counts
Participants	OG000175 OG00181 OG00281

Title

Denominators

Categories

Anti-1

- ParticipantsOG000175
- ParticipantsOG00176
- ParticipantsOG00281

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.					Adjusted GMC ratio	0.87			2-Sided	95	0.72	1.05					Non-Inferiority	Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.

Primary

Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value

The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Primary

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers

Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 1

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group

Secondary

Anti-pneumococcal Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Before vaccination (PRE) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Cross-reactive Anti-pneumococcal Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Opsonophagocytic Titers Against Pneumococcal Serotypes

Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes

Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Anti-protein D (Anti-PD) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002

Secondary

rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers

Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before vaccination (PRE) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group

Secondary

Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002

Secondary

Anti-tetanus (Anti-T) Antibody Concentrations

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.

The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) post-vaccination period after each dose

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects with the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) post-vaccination period after each dose

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Within the 31-day (Day 0-30) post-vaccination period after each dose

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Throughout the entire study duration (Day 0-Month 7)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Number of Subjects Reporting Rash

Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Throughout the entire study duration (Day 0-Month 7)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Number of Subjects With New Onset Chronic Illnesses (NOCIs)

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Throughout the entire study duration (Day 0-Month 7)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Secondary

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.

The analysis was done on the Total Vaccinated cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Throughout the entire study duration (Day 0-Month 7)

ID	Title	Description
OG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.
OG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nimenrix + Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix vaccine and Synflorix booster vaccine at Month 0. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	182	6	182	154	182
EG001	Nimenrix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Nimenrix conjugate vaccine at Month 0 and Synflorix booster vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	91	3	91	81	91
EG002	Synflorix Group	Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.	90	4	90	76	90

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchopneumonia	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0012 affected91 at risk EG0020 affected90 at risk
Croup infectious	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Oral herpes	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0010 affected91 at risk EG0022 affected90 at risk
Bronchiolitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Febrile convulsion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Gastroenteritis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0010 affected91 at risk EG0021 affected90 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0011 affected91 at risk EG0020 affected90 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Infantile asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Otitis media acute	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0011 affected91 at risk EG0020 affected90 at risk
Pharyngitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected182 at risk EG0010 affected91 at risk EG0020 affected90 at risk
Teratoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0010 affected91 at risk EG0021 affected90 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected182 at risk EG0010 affected91 at risk EG0021 affected90 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis (post-Dose 1)	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00025 affected182 at risk EG00115 affected91 at risk EG00218 affected90 at risk
Upper respiratory tract infection (post-Dose 1)	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG00022 affected182 at risk EG0016 affected91 at risk EG0029 affected90 at risk
Nasopharyngitis (post-Dose 2)	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00114 affected91 at risk EG0027 affected90 at risk
Upper respiratory tract infection (post-Dose 2)	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG0016 affected91 at risk EG0025 affected90 at risk
Upper respiratory tract infection bacterial (post-Dose 2)	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG0012 affected91 at risk EG0025 affected90 at risk
Pain (post-Dose 1 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00090 affected180 at risk EG0010 affected0 at risk EG00247 affected88 at risk
Pain (post-Dose 1 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00087 affected180 at risk EG00140 affected91 at risk EG0020 affected0 at risk
Redness (post-Dose 1 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00054 affected180 at risk EG0010 affected0 at risk EG00232 affected88 at risk
Redness (post-Dose 1 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00056 affected180 at risk EG00131 affected91 at risk EG0020 affected0 at risk
Swelling (post-Dose 1 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00070 affected180 at risk EG0010 affected0 at risk EG00242 affected88 at risk
Swelling (post-Dose 1 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG00066 affected180 at risk EG00137 affected91 at risk EG0020 affected0 at risk
Pain (post-Dose 2 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00143 affected91 at risk EG0020 affected0 at risk
Pain (post-Dose 2 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00234 affected85 at risk
Redness (post-Dose 2 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00129 affected91 at risk EG0020 affected0 at risk
Redness (post-Dose 2 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00224 affected85 at risk
Swelling (post-Dose 2 of Synflorix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00138 affected91 at risk EG0020 affected0 at risk
Swelling (post-Dose 2 of Nimenrix)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG0010 affected0 at risk EG00230 affected85 at risk
Drowsiness (post-Dose 1)	General disorders	MedDRA 12.1	Systematic Assessment	EG00059 affected180 at risk EG00121 affected91 at risk EG00235 affected88 at risk
Irritability (post-Dose 1)	General disorders	MedDRA 12.1	Systematic Assessment	EG00072 affected180 at risk EG00133 affected91 at risk EG00243 affected88 at risk
Loss of appetite (post-Dose 1)	General disorders	MedDRA 12.1	Systematic Assessment	EG00055 affected180 at risk EG00122 affected91 at risk EG00233 affected88 at risk
Temperature (post-Dose 1)	General disorders	MedDRA 12.1	Systematic Assessment	EG00025 affected180 at risk EG00110 affected91 at risk EG00215 affected88 at risk
Drowsiness (post-Dose 2)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00125 affected91 at risk EG00217 affected85 at risk
Irritability(post-Dose 2)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00135 affected91 at risk EG00229 affected85 at risk
Loss of appetite (post-Dose 2)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00122 affected91 at risk EG00222 affected85 at risk
Temperature (post-Dose 2)	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected0 at risk EG00118 affected91 at risk EG00211 affected85 at risk

ID	Term
D008589	Meningococcal Infections

OG0003.43(3.06 to 3.85)

OG0010.33(0.27 to 0.41)

OG0023.60(2.96 to 4.38)

Subjects aged 12 to 23 months, male or female, primed with Synflorix vaccine who received Synflorix booster vaccine at Month 0 and Nimenrix conjugate vaccine at Month 1. Both vaccines were administered intramuscularly, in the right thigh for the Nimenrix conjugate vaccine, in the left thigh for the Synflorix vaccine.

OG0012044.0(1522.8 to 2743.6)

OG0026.4(4.7 to 8.7)

(10270.7 to 13398.9)

OG0018407.7(6225.4 to 11355.0)

OG00235.8(21.5 to 59.6)

OG0015606.2(4484.5 to 7008.3)

OG00268.4(39.9 to 117.2)

OG0022.32(1.88 to 2.87)

OG0010.57(0.45 to 0.72)

OG0020.49(0.39 to 0.61)

OG0024.05(3.30 to 4.97)

OG0010.55(0.45 to 0.67)

OG0020.48(0.39 to 0.59)

OG0023.22(2.75 to 3.78)

OG0010.53(0.40 to 0.69)

OG0020.48(0.36 to 0.64)

OG0022.18(1.77 to 2.69)

OG0010.95(0.80 to 1.14)

OG0020.71(0.58 to 0.87)

OG0023.85(3.18 to 4.66)

OG0010.85(0.68 to 1.06)

OG0020.75(0.61 to 0.93)

OG0023.07(2.53 to 3.73)

OG0011.37(1.06 to 1.77)

OG0021.29(0.97 to 1.72)

OG0026.79(5.51 to 8.36)

OG0010.82(0.61 to 1.10)

OG0020.87(0.68 to 1.11)

OG00214.14(11.08 to 18.04)

OG0011.35(0.97 to 1.88)

OG0021.08(0.78 to 1.50)

OG00212.35(10.23 to 14.91)

OG0010.67(0.48 to 0.92)

OG0020.53(0.39 to 0.70)

OG0022.72(2.15 to 3.43)

OG0010.28(0.20 to 0.39)

OG0022.07(1.56 to 2.76)

OG0021.30(0.98 to 1.71)

OG0010.18(0.13 to 0.25)

OG0020.16(0.12 to 0.21)

OG0010.22(0.16 to 0.30)

OG0022.50(1.89 to 3.30)

OG0021.51(1.12 to 2.04)

OG0018.2(4.4 to 15.3)

OG002438.6(224.4 to 857.2)

OG002238.0(117.5 to 482.0)

OG00114.9(6.7 to 32.9)

OG00224.9(9.0 to 68.6)

OG00110.3(5.3 to 19.8)

OG0023621.3(2488.8 to 5269.1)

OG0021427.7(683.8 to 2980.6)

OG00110.8(7.1 to 16.4)

OG00212.7(7.7 to 20.9)

OG00111.0(5.9 to 20.6)

OG002332.7(227.2 to 487.1)

OG002308.9(188.2 to 506.9)

OG00126.1(11.0 to 61.9)

OG00242.7(12.5 to 146.5)

OG00156.1(16.9 to 186.8)

OG0021158.7(539.3 to 2489.4)

OG002560.6(223.6 to 1405.3)

OG0011588.3(1103.6 to 2286.0)

OG0021843.1(1385.7 to 2451.6)

OG0012051.2(1304.0 to 3226.5)

OG0025421.5(3948.8 to 7443.5)

OG0024444.3(2918.5 to 6768.0)

OG001627.7(427.3 to 921.9)

OG0021269.8(798.4 to 2019.4)

OG001445.2(218.9 to 905.5)

OG0024862.0(3345.5 to 7065.9)

OG0023392.6(2236.5 to 5146.4)

OG001324.7(161.5 to 652.9)

OG002320.5(155.6 to 660.3)

OG001214.3(69.3 to 663.1)

OG0023914.0(2506.7 to 6111.5)

OG0022149.0(1381.5 to 3342.8)

OG00110.5(5.1 to 21.6)

OG00213.2(6.6 to 26.2)

OG0018.2(3.7 to 18.2)

OG0025616.8(3209.6 to 9829.3)

OG0024190.1(2326.8 to 7545.6)

OG00134.2(15.5 to 75.1)

OG00232.9(14.7 to 73.4)

OG00157.3(19.0 to 172.5)

OG0022534.2(1794.5 to 3578.8)

OG0021260.4(788.8 to 2013.8)

OG00198.1(27.6 to 348.2)

OG002460.2(139.7 to 1515.3)

OG001199.0(33.9 to 1168.7)

OG0023794.6(2392.0 to 6019.9)

OG0023284.2(2184.6 to 4937.3)

OG00159.4(17.4 to 202.7)

OG002696.6(359.9 to 1348.2)

OG002284.1(105.4 to 765.5)

OG0015.9(3.6 to 9.6)

OG0027.0(3.8 to 13.2)

OG0016.3(3.5 to 11.3)

OG002214.5(75.3 to 611.0)

OG00286.8(28.2 to 267.2)

OG001632.6(468.1 to 854.9)

OG0022452.3(1790.1 to 3359.6)

OG0021854.3(1313.1 to 2618.4)

OG0025288.0(4498.0 to 6216.9)

OG0016.1(4.7 to 8.0)

OG0027.7(5.6 to 10.7)

OG0021579.9(1218.9 to 2048.0)

OG00132.7(19.8 to 53.9)

OG00239.6(23.9 to 65.4)

OG0027666.8(6502.8 to 9039.0)

OG00174.4(44.7 to 123.9)

OG00277.0(45.5 to 130.4)

OG0026461.1(5329.3 to 7833.2)

OG00141.94(26.38 to 66.67)

OG0020.19(0.15 to 0.23)

OG00219.80(14.68 to 26.71)

OG0010.15(0.15 to 0.15)

OG0020.16(0.15 to 0.17)

OG00124.54(17.77 to 33.89)

OG0020.16(0.14 to 0.17)

OG0029.62(7.33 to 12.63)

OG0010.16(0.14 to 0.19)

OG0020.15(0.15 to 0.15)

OG00111.68(8.06 to 16.92)

OG0020.15(0.15 to 0.15)

OG0026.75(4.94 to 9.22)

OG0010.17(0.14 to 0.19)

OG0020.16(0.14 to 0.17)

OG00110.78(7.24 to 16.05)

OG0020.15(0.15 to 0.16)

OG0028.47(6.45 to 11.10)

OG00118.137(12.085 to 27.218)

OG0024.412(3.298 to 5.901)

OG00213.773(10.932 to 17.352)

ID	Term
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections