Immunogenicity and Safety of Menactra® Vaccine in Subject... | NCT01890759

NCT01890759

ID	Type	Description	Link
U1111-1122-2171	Other Identifier	WHO
CTRI/2014/12/005272	Registry Identifier	Clinical Trials Registry - India

Status Module

Sponsor/Collaborators Module

Oversight Module

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
Meningococcal Diphtheria Toxoid Vaccine	Experimental	Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart	Biological: Meningococcal Diphtheria Toxoid Vaccine

Name	Type	Description	Arm Group Labels	Other Names
Meningococcal Diphtheria Toxoid Vaccine	Biological	0.5 mL, Intramuscular	Meningococcal Diphtheria Toxoid Vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®	Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.	Day 0 (pre-vaccination) and Day 28 post-second vaccination

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®	Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects aged 9 to 17 months on the day of inclusion
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for:
(i) influenza vaccination, which may be received at least 2 weeks before study vaccines.
(ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
(iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)
Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically
At high risk, in the opinion of the Investigator, for meningococcal disease during the trial
Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Known thrombocytopenia, contraindicating intramuscular vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
In an emergency setting, or hospitalized involuntarily
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C).
For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C).

A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.

Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Personal history of Guillain-Barré Syndrome.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Sanofi Pasteur SA	Study Director

References Module

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
FG001	India

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

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
BG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000100 BG001200 BG002300

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG000100 BG001200 BG002300
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

Age Continuous

Title	Measurements
	BG00013.5± 2.7 BG00112.9± 3.0 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00059 BG00169 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

Russia

Title	Measurements
	BG000100 BG0010 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

Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.

Seroprotection was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-second vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants	OG00077 OG001169

Title

Denominators

Categories

Serogroup A; Pre vaccination 1 (N=77,169)

Title	Measurements
	OG00045.5 OG00155.0

Serogroup A; Post vaccination 2 (N=77,166)

Title	Measurements
	OG000

Secondary

Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.

Threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

The threshold was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.

Seroprotection was assessed in the Per Protocol Analysis Set.

Posted

Number

Percentage of participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Geometric mean titers were assessed in the Per Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dil)

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.

Geometric mean titers were assessed in the Per Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers (1/dil)

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.

Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titer ratios

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®

Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.

Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titer ratios

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Units	Counts
Participants

Secondary

Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®

Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.

Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.

Posted

Number

Percentage of participants

Day 0 up to Day 7 post-each vaccination

ID	Title	Description
OG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
OG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Russian Federation	Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.	0	100	1	100	35	100
EG001	India	Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.	0	199	3	199	40	199

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	MedDRA v15	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected199 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v15	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected199 at risk
Nasopharyngitis	Infections and infestations	MedDRA v15	Non-systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected199 at risk
Respiratory tract infection	Infections and infestations	MedDRA v15	Non-systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected199 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site Tenderness	General disorders	MedDRA v15	Systematic Assessment	EG00024 events24 affected100 at risk EG00140 events40 affected199 at risk
Injection site Erythema	General disorders	MedDRA v15	Systematic Assessment	EG00035 events35 affected100 at risk EG00112 events12 affected199 at risk
Injection site Swelling	General disorders	MedDRA v15	Systematic Assessment	EG00013 events13 affected100 at risk EG00110 events10 affected199 at risk
Fever	General disorders	MedDRA v15	Systematic Assessment	EG0006 events6 affected100 at risk EG00125 events25 affected199 at risk
Crying abnormal	Psychiatric disorders	MedDRA v15	Systematic Assessment	EG00015 events15 affected100 at risk EG00133 events33 affected199 at risk
Drowsiness	Nervous system disorders	MedDRA v15	Systematic Assessment	EG00022 events22 affected100 at risk EG00124 events24 affected199 at risk
Appetite lost	Metabolism and nutrition disorders	MedDRA v15	Systematic Assessment	EG00021 events21 affected100 at risk EG00140 events40 affected199 at risk
Irritability	Psychiatric disorders	MedDRA v15	Systematic Assessment	EG00029 events29 affected100 at risk EG00134 events34 affected199 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v15	Non-systematic Assessment	EG0000 events0 affected100 at risk EG00111 events10 affected199 at risk
Vomiting	Gastrointestinal disorders	MedDRA v15	Systematic Assessment	EG0002 events2 affected100 at risk EG00130 events30 affected199 at risk

ID	Term
D008581	Meningitis
D008589	Meningococcal Infections

Ancestor Terms

ID	Term
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D016870	Neisseriaceae Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D022401	Meningococcal Vaccines

BG0000
BG0010
BG0020

Facility	Status	City	State	ZIP	Country	Contacts
		Vadodara	Gujarat	390022	India

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