Immunogenicity and Safety of Meningococcal Vaccine GSK134... | NCT00454909

NCT00454909

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Subjects aged 10 years (< 11 years) vaccinated with meningococcal vaccine GSK134612.	Biological: Meningococcal vaccine 134612
Group B	Experimental	Subjects aged 11 to 25 years vaccinated with meningococcal vaccine GSK134612.	Biological: Meningococcal vaccine 134612
Group C	Active Comparator	Subjects aged 11 to 25 years vaccinated with Menactra®.	Biological: Menactra®

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal vaccine 134612	Biological	Single dose intramuscular injection.	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC , hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.	At Day 0 (PRE)
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y) Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.	At Month 1

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.	At Day 0 (PRE) and Month 1
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects whom the investigator believes can and will comply with the requirements of the protocol.
A male or female between, and including, 10 and 25 years of age (has not attained his/her 26th birthday) at the time of the vaccination.
Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
Healthy subjects as established by medical history and clinical examination before entering into the study.
If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception (including abstinence) for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, 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 vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W-135, and/or Y.
Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine within the last month).
History of meningococcal disease due to serogroup A, C, W-135, or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Previous history of Guillain-Barré Syndrome.
Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
Acute disease at the time of enrollment.
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.
Pregnant or lactating female.
History of chronic alcohol consumption and/or drug abuse.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Daly City	California	94015	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21200360	Background	Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011 Mar;30(3):e41-8. doi: 10.1097/INF.0b013e3182054ab9.
	Background	Baxter R et al. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults: 1-year follow-up. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial Agents & Chemotherapy. Chicago, US, 17-20 September 2011.

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
109377	Study Protocol	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
FG001	Menactra Group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
BG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
BG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG000587 BG001197 BG00288 BG003872

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

Years

Title

Denominators

Categories

Title	Measurements
	BG00014.8± 2.69 BG00114.7± 2.78 BG00210± 0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000274 BG001101 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

African heritage/African American

Title	Measurements
	BG00035 BG00112 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

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

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

The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available. The interval between Visit 1 (Month 0) and Visit 2 (Month 1) for inclusion in this cohort was defined as 21 to 48 days.

Posted

Count of Participants

Participants

At Day 0 (PRE)

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000506 OG001174 OG00277

Title

Denominators

Categories

hSBA-MenA

- ParticipantsOG000503
- ParticipantsOG001172
- ParticipantsOG00277

Title	Measurements

Primary

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

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

Posted

Count of Participants

Participants

At Month 1

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers Greater Than or Equal to the Cut-off Value

The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

Posted

Count of Participants

Participants

At Day 0 (PRE) and Month 1

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

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

Antibody titers are presented as geometric mean titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 (PRE) and Month 1

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

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

Assessed solicited general symptoms were fatigue, fever [defined as orally temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

During the 4-day (Days 0-3) and the 8-day (Days 0-7) post-vaccination period

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

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 analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

During the 31-day (Days 0-30) follow-up period after vaccination

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received on dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group

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 analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

From Day 0 to Month 6

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Secondary

Number of Subjects With New Onset Chronic Illness(es) (NOCI)

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

The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

From Day 0 to Month 6

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Units

Secondary

Number of Subjects Reporting Rash

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

From Day 0 to Month 6

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts

Secondary

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

The analyses were performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Posted

Count of Participants

Participants

From Day 0 to Month 6

ID	Title	Description
OG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
OG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nimenrix 11-25Y Group	Subjects, male or female, aged 11 to 25 years received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.	587	5	587	438	587
EG001	Menactra Group	Subjects, male or female, aged 11 to 25 years received one dose of Menactra® vaccine administered intramuscularly in the deltoid region of the non-dominant arm.	197	2	197	142	197
EG002	Nimenrix 10Y Group	Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.	88	2	88	68	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected587 at risk EG0010 affected197 at risk EG0021 affected88 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0000 affected587 at risk EG0011 affected197 at risk EG0020 affected88 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected587 at risk EG0011 affected197 at risk EG0020 affected88 at risk
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected587 at risk EG0010 affected197 at risk EG0021 affected88 at risk
Swelling	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected587 at risk EG0010 affected197 at risk EG0020 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG000317 affected579 at risk EG001105 affected194 at risk EG00248 affected86 at risk
Redness (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG00077 affected579 at risk EG00121 affected194 at risk EG00215 affected86 at risk
Swelling (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG00062 affected579 at risk EG00113 affected194 at risk EG00218 affected86 at risk
Pain (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG000318 affected579 at risk EG001105 affected194 at risk EG00248 affected86 at risk
Redness (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG00077 affected579 at risk EG00121 affected194 at risk EG00215 affected86 at risk
Swelling (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG00063 affected579 at risk EG00113 affected194 at risk EG00218 affected86 at risk
Fatigue (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG000156 affected579 at risk EG00155 affected194 at risk EG00224 affected86 at risk
Fever/Orally (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG00034 affected579 at risk EG00111 affected194 at risk EG0026 affected86 at risk
Gastrointestinal (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG00087 affected579 at risk EG00126 affected194 at risk EG00211 affected86 at risk
Headache (Days 0-3)	General disorders	MedDRA 12.0	Systematic Assessment	EG000161 affected579 at risk EG00160 affected194 at risk EG00227 affected86 at risk
Fatigue (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG000172 affected579 at risk EG00162 affected194 at risk EG00227 affected86 at risk
Fever/Orally (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG00041 affected579 at risk EG00116 affected194 at risk EG0027 affected86 at risk
Gastrointestinal (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG000109 affected579 at risk EG00132 affected194 at risk EG00215 affected86 at risk
Headache (Days 0-7)	General disorders	MedDRA 12.0	Systematic Assessment	EG000191 affected579 at risk EG00172 affected194 at risk EG00230 affected86 at risk

ID	Term
D008589	Meningococcal Infections

ID	Term
D022401	Meningococcal Vaccines

Units	Counts
Participants	OG000517 OG001174 OG00279

Subjects, male or female, aged 10 years (<11 years) of age received one dose of Nimenrix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

Units	Counts
Participants	OG000587 OG001197 OG00288

OG00136.0(26.1 to 49.7)

OG00291.5(64.0 to 130.8)

OG00117.9(13.5 to 23.6)

OG0029.7(6.7 to 14.2)

OG001285.8(214.7 to 380.5)

OG002765.9(505.3 to 1160.9)

OG0018.6(6.1 to 12.1)

OG0024.2(2.8 to 6.4)

OG00174.1(51.1 to 107.5)

OG002153.8(109.9 to 215.1)

OG00127.6(19.0 to 40.2)

OG00213.7(8.0 to 23.6)

OG001110.6(77.6 to 157.9)

OG002315.0(223.6 to 443.7)

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

ID	Term
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures