Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02287688
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Actual Duration (Months): 35.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This safety surveillance study of GlaxoSmithKline's quadrivalent meningococcal ACWY conjugate vaccine (Meningococcal quadrivalent CRM-197) among children 2 months through 23 months of age is a post-marketing study required by the United States Food and Drug Administration.

It is an observational study of children 2-23 months of age who receive at least one dose of MenACWY-CRM vaccine at a Kaiser Permanente Southern California facility (KPSC) while enrolled as a KPSC health plan member.

The objective of the infant study is to describe medical events that require emergency room visit or hospitalization in 6 months following MenACWY-CRM vaccination in children 2-23 months of age in a health maintenance organization in the United States. Outcomes include medical events that require emergency room visits or hospitalizations in children 2-23 months of age following any dose of MenACWY-CRM vaccination. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination will be excluded as a pre-existing condition.

Condition or Disease	Intervention/Treatment	Phase
Meningococcal Disease; Infections, Meningococcal	Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine

Study Design

• Study Type: Observational
• Actual Enrollment: 144 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (MENVEO®) in Children 2 Months Through 23 Months of Age.
• Actual Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Nov 29, 2017
• Actual Study Completion Date: Nov 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Exposure group Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.	Biological: Meningococcal quadrivalent CRM-197 conjugate vaccine; This study is strictly observational. Decisions of vaccination are made by health care providers.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Who Experienced Single or Multiple Medical Encounters [Within 6 months after any dose of MenACWY-CRM vaccination]

   The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported

2. Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination [Within 6 months after any dose of MenACWY-CRM]

   All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care.

3. Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination [Within 6 months after any dose of MenACWY-CRM]

   The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first.

4. Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses [Within 6 months after any dose of MenACWY-CRM]

   Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported

5. Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination [Within 6 months after any dose of MenACWY-CRM]

   All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.

6. Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination [Within 6 months after any dose of MenACWY-CRM]

   The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Months to 23 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• children 2-23 months of age at the time of MenACWY-CRM vaccination

• hold KPSC membership at the time of MenACWY-CRM vaccination

• vaccinated with MenACWY-CRM during the study period in KPSC

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Pasadena	California	United States	91101

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - Aug 11, 2016
• Statistical Analysis Plan - Oct 30, 2015

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02287688
• Other Study ID Numbers: 205534; V59_74OB
• First Posted: Nov 11, 2014
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by GlaxoSmithKline: safety of Meningococcal quadrivalent CRM-197 conjugate vaccine; Children 2-23 months of age
• Additional relevant MeSH terms: Meningococcal Infections

Study Results

Participant Flow

Recruitment Details	There were 5,612,052 members of Kaiser Permanente of Southern California (KPSC) health plan during the study period. Among these,108,325 were children 2 to 23 months old. A total of 144 subjects aged 2 to 23 months who received at least one dose of MenACWY-CRM vaccine, were enrolled in this study.
Pre-assignment Detail	Out of the 144 subjects enrolled, only 138 subjects were analysed in this study as 6 subjects did not meet the inclusion criteria.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Period Title: Overall Study
STARTED	138
COMPLETED	138
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Overall Participants	138
Age (Months) [Mean (Standard Deviation) ]
Age at first vaccination	11.5 (6.6)
Sex: Female, Male (Count of Participants)
Female	70 50.7%
Male	68 49.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Who Experienced Single or Multiple Medical Encounters
Description	The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported
Time Frame	Within 6 months after any dose of MenACWY-CRM vaccination

Outcome Measure Data

Analysis Population Description

Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
Single medical encounter	16 11.6%
Multiple medical encounters	24 17.4%

2. Primary Outcome

Title	Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Description	All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care.
Time Frame	Within 6 months after any dose of MenACWY-CRM

Outcome Measure Data

Analysis Population Description

Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
ED and/or hospitalization encounters	102
Hospitalization only	32
Emergency department only	57
Emergency department to hospital transfer	13

3. Primary Outcome

Title	Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Description	The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first.
Time Frame	Within 6 months after any dose of MenACWY-CRM

Outcome Measure Data

Analysis Population Description

Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
Hospitalization only	0.4
Emergency department only	0.6
Emergency department to hospital transfer	0.1

4. Primary Outcome

Title	Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses
Description	Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported
Time Frame	Within 6 months after any dose of MenACWY-CRM

Outcome Measure Data

Analysis Population Description

Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
Single medical diagnosis	6 4.3%
Multiple medical diganoses	34 24.6%

5. Primary Outcome

Title	Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Description	All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.
Time Frame	Within 6 months after any dose of MenACWY-CRM

Outcome Measure Data

Analysis Population Description

Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
Intestinal infection, other organism (ICD-008.8)	2
Septicemia, pseudomonas (038.43)	1
Pseudomonas infection (041.7)	1
Other specified bacterial infections(041.85)	1
Viral exanthem, unspecified(057.9)	1
Adenovirus infection(079.0)	2
Rhinovirus infection(079.3)	1
Other specified viral infection(079.89)	2
Unspecified viral infection(079.99)	1
Candidiasis of mouth(112.0)	1
Hyposmolality and/or hyponatremia(276.1)	1
Acidosis(276.2)	2
Dehydration(276.51)	6
Hyperpotassemia(276.7)	1
Hb-SS disease with crisis(282.62)	2
Other pancytopenia(284.19)	1
Acute posthemorrhagic anemia(285.1)	1
Anemia, unspecified(285.9)	4
Leukocytosis, unspecified(288.60)	1
Other specified delays in development(315.8)	1
Cerebral degeneration(331.7)	1
Epilepsy, unspecified(345.90)	2
Encephalopathy, unspecified(348.30)	1
Cerebral edema(348.5)	1
Conjunctivitis, unspecified(372.30)	2
Redness or discharge of eye(379.93)	1
Unspecified otitis media(382.9)	6
Cardiomegaly(429.3)	1
Subdural hemorrhage(432.1)	1
Cerebral artery occlusion(434.91)	1
Acute venous embolism and thrombosis(453.41)	1
Acute sinusitis, unspecified(461.9)	1
Acute upper respiratory infections(465.9)	10
Acute bronchitis(466.0)	3
Acute bronchiolitis,RSV(466.11)	1
Acute bronchiolitis,other organisms(466.19)	1
Chronic rhinitis(472.0)	1
Pneumonia, parainfluenza virus(480.2)	2
Pneumonia,other virus not classified(480.8)	2
Pneumococcal pneumonia(481)	1
Pneumonia, Pseudomonas(482.1)	1
Pneumonia, other gram-negative bacteria(482.83)	1
Pneumonia, mycoplasma pneumoniae(483.0)	1
Pneumonia, organism unspecified(486)	5
Influenza-other respiratory manifestations(487.1)	4
Asthma, unspecified type, unspecified(493.90)	1
Effusion, other (except tuberculous)(511.89)	1
Pulmonary congestion and hypostasis(514)	1
Unspecified pneumonopathy(516.9	1
Pulmonary collapse(518.0)	1
Acute respiratory failure(518.81)	3
Other pulmonary insufficiency(518.82)	2
Other gastrostomy complications(536.49)	1
Other disorders-stomach & duodenum(537.89)	1
Noninfectious gastroenteritis &colitis,other(558.9	3
Constipation, unspecified(564.00)	2
Anal sphincter tear (healed) (old)(569.43)	1
Urinary tract infection, site not specified(599.0)	2
Microscopic hematuria(599.72)	1
Diaper or napkin rash(691.0)	3
Allergic urticaria(708.0)	1
Pain in joint, lower leg(719.46)	1
Pain in limb(729.5)	1
Swelling of limb(729.81)	1
Other anomalies of great veins(747.49)	1
Other anomalies of female genitalia(752.49)	1
Anomalies of skull and face bones(756.0)	1
Hypoxicischemic encephalopathy,unspecified(768.70)	1
Complex febrile convulsions(780.32)	1
Other convulsions(780.39)	2
Fever, unspecified(780.60)	25
Fever with conditions classified elsewhere(780.61)	11
Postvaccination fever(780.63)	1
Altered mental status(780.97)	1
Rash & other nonspecific skin eruption(782.1)	2
Feeding difficulties & mismanagement(783.3)	1
Tachycardia, unspecified(785.0)	2
Tachypnea(786.06)	1
Wheezing(786.07)	2
Other respiratory abnormalities(786.09)	3
Cough(786.2)	5
Abnormal chest sounds(786.7)	1
Nausea with vomiting(787.01)	2
Vomiting alone(787.03)	1
Flatulence,eructation & gas pain(787.3)	1
Diarrhea(787.91)	4
Other symptoms involving digestive system(787.99)	1
Splenomegaly(789.2)	2
Bacteremia(790.7)	1
Viremia, unspecified(790.8)	5
Other abnormal finding of lung field(793.19)	2
Abnormal results,pulmonary function(794.2)	1
Hypoxemia(799.02)	2
Subarachnoid hemorrhage following injury(852.00)	1
Subdural hemorrhage following injury(852.2)	1
Subdural hemorrhage unspecified(852.20)	1
Open wound of finger(s)(883.0)	1
Insect bite,nonvenomous of lower limb(916.4)	1
Contusion of chest wall(922.1)	1
Foreign body in digestive system,unspecified(938)	1
Head injury, unspecified(959.01)	1
Knee, leg, ankle, and foot injury(959.7)	1
Child abuse, unspecified(995.50)	1
Child physical abuse(995.54)	2
Vascular device,implant,graft,complications(996.74	1
Body systems,complications,hypertension(997.91)	1
Other external cause status(E000.8)	2
Other activity(E029.9)	2
Traffic accident-passenger injury(E812.1)	1
Home accidents(E849.0)	2
Accidents occurring in unspecified place(E849.9)	3
Surgical operations & procedures, (E878.8)	1
Other procedures, complication(E879.8)	1
Accidental fall on/from other stairs/steps(E880.9)	1
Unspecified fall(E888.9)	1
Bite of nonvenomous arthropod(E906.4)	1
Accidents caused by cutting and piercing(E920.8)	1
Other accidents(E928.8)	1
Unspecified accident(E928.9)	1

6. Primary Outcome

Title	Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Description	The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.
Time Frame	Within 6 months after any dose of MenACWY-CRM

Outcome Measure Data

Analysis Population Description

Analysis was performed on medical events collected from children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.

Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
Measure Participants	138
Intestinal infection, other organism (ICD-008.8)	0.0
Septicemia, pseudomonas (038.43)	0.0
Pseudomonas infection(041.7)	0.0
Other specified bacterial infections(041.85)	0.0
Viral exanthem, unspecified(057.9)	0.0
Adenovirus infection(079.0)	0.0
Rhinovirus infection(079.3)	0.0
Other specified viral infection(079.89)	0.0
Unspecified viral infection(079.99)	0.0
Candidiasis of mouth(112.0)	0.0
Hyposmolality and/or hyponatremia(276.1)	0.0
Acidosis(276.2)	0.0
Dehydration(276.51)	0.1
Hyperpotassemia(276.7)	0.0
Hb-SS disease with crisis(282.62)	0.0
Other pancytopenia(284.19)	0.0
Acute posthemorrhagic anemia(285.1)	0.0
Anemia, unspecified(285.9)	0.0
Leukocytosis, unspecified(288.60)	0.0
Other specified delays in development(315.8)	0.0
Cerebral degeneration(331.7)	0.0
Epilepsy, unspecified(345.90)	0.0
Encephalopathy, unspecified(348.30)	0.0
Cerebral edema(348.5)	0.0
Conjunctivitis, unspecified(372.30)	0.0
Redness or discharge of eye(379.93)	0.0
Unspecified otitis media(382.9)	0.1
Cardiomegaly(429.3)	0.0
Subdural hemorrhage(432.1)	0.0
Cerebral artery occlusion(434.91)	0.0
Acute venous embolism & thrombosis(453.41)	0.0
Acute sinusitis, unspecified(461.9)	0.0
Acute upper respiratory infections(465.9)	0.1
Acute bronchitis(466.0)	0.0
Acute bronchiolitis, RSV(466.11)	0.0
Acute bronchiolitis, other organisms(466.19)	0.0
Chronic rhinitis(472.0)	0.0
Pneumonia-parainfluenza virus(480.2)	0.0
Pneumonia, other virus(480.8)	0.0
Pneumococcal pneumonia(481)	0.0
Pneumonia, Pseudomonas(482.1)	0.0
Pneumonia, gram-negative bacteria(482.83)	0.0
Pneumonia, mycoplasma pneumoniae(483.0)	0.0
Pneumonia, organism unspecified(486)	0.1
Influenza-other respiratory manifestations(487.1)	0.0
Asthma,unspecified type,unspecified(493.90)	0.0
Effusion,other except tuberculous(511.89)	0.0
Pulmonary congestion & hypostasis(514)	0.0
Parieto/alveolar pneumonopathy,other(516.9)	0.0
Pulmonary collapse(518.0)	0.0
Acute respiratory failure(518.81)	0.0
Other pulmonary insufficiency(518.82)	0.0
Other gastrostomy complications(536.49)	0.0
Other disorders-stomach & duodenum(537.89)	0.0
Noninfectious gastroenteritis&colitis,other(558.9)	0.0
Constipation, unspecified(564.00)	0.0
Anal sphincter tear (healed)(old)(569.43)	0.0
Urinary tract infection,site not specified(599.0)	0.0
Microscopic hematuria(599.72)	0.0
Diaper or napkin rash(691.0)	0.0
Allergic urticaria(708.0)	0.0
Pain in joint, lower leg(719.46)	0.0
Pain in limb(729.5)	0.0
Swelling of limb(729.81)	0.0
Other anomalies of great veins(747.49)	0.0
Other anomalies of female genitalia(752.49)	0.0
Anomalies of skull & face bones(756.0)	0.0
Hypoxicischemic encephalopathy,unspecified(768.70)	0.0
Complex febrile convulsions(780.32)	0.0
Other convulsions(780.39)	0.0
Fever, unspecified(780.60)	0.3
Fever with conditions classified elsewhere(780.61)	0.1
Postvaccination fever(780.63)	0.0
Altered mental status(780.97)	0.0
Rash & other nonspecific skin eruption(782.1)	0.0
Feeding difficulties & mismanagement(783.3)	0.0
Tachycardia,unspecified(785.0)	0.0
Tachypnea(786.06)	0.0
Wheezing(786.07)	0.0
Other respiratory abnormalities(786.09)	0.0
Cough(786.2)	0.1
Abnormal chest sounds(786.7)	0.0
Nausea with vomiting(787.01)	0.0
Vomiting alone(787.03)	0.0
Flatulence, eructation & gas pain(787.3)	0.0
Diarrhea(787.91)	0.0
Other symptoms-digestive system(787.99)	0.0
Splenomegaly(789.2)	0.0
Bacteremia(790.7)	0.0
Viremia,unspecified(790.8)	0.1
Other abnormal finding of lung field(793.19)	0.0
Abnormal results,pulmonary function study(794.2)	0.0
Hypoxemia(799.02)	0.0
Subarachnoid hemorrhage,consciousness(852.00)	0.0
Subdural hemorrhage following injury(852.2)	0.0
Subdural hemorrhage,consciousness(852.20)	0.0
Open wound of finger(s)(883.0)	0.0
Insect bite,nonvenomous of lower limb(916.4)	0.0
Contusion of chest wall(922.1)	0.0
Foreign body in digestive system,unspecified(938)	0.0
Head injury, unspecified(959.01)	0.0
Knee,leg,ankle & foot injury(959.7)	0.0
Child abuse, unspecified(995.50)	0.0
Child physical abuse(995.54)	0.0
Vascular device implant&graft,complications(996.74	0.0
Body systems,hypertension,complications(997.91)	0.0
Other external cause status(E000.8)	0.0
Other activity(E029.9)	0.0
Traffic accident-passenger injury(E812.1)	0.0
Home accidents(E849.0)	0.0
Accidents occurring in unspecified place(E849.9)	0.0
Surgical operations & procedures(E878.8)	0.0
Specified procedures, complications(E879.8)	0.0
Accidental fall on/from other stairs/steps(E880.9)	0.0
Unspecified fall(E888.9)	0.0
Bite of nonvenomous arthropod(E906.4)	0.0
Accidents caused by cutting & piercing(E920.8)	0.0
Other accidents(E928.8)	0.0
Unspecified accident(E928.9)	0.0

Adverse Events

Time Frame	Not applicable as adverse events were not monitored in this study.
Adverse Event Reporting Description	Adverse events were not monitored in this study as this is an Non-interventional study based on the secondary use of Kaiser Permanente Southern California (KPSC) electronic records. There was no assessment of AEs related to study vaccination as MenACWY-CRM vaccine was given as part of the clinical care at KPSC. Reporting of number and rate of medical diagnosis is from pre-existing records in these centers.
Arm/Group Title	Exposure Group
Arm/Group Description	Subjects aged 2-23 months who received at least one dose of the MenACWY-CRM vaccine at a Kaiser Permanente Southern California (KPSC) facility while enrolled as a KPSC health plan member.
All Cause Mortality
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Exposure Group
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.