Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (MENVEO®) in Children 2 Months Through 23 Months of Age.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02287688

Enrollment

144

Registered

2014-11-11

Start date

2014-12-01

Completion date

2017-11-29

Last updated

2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Meningococcal, Meningococcal Disease

Keywords

safety of Meningococcal quadrivalent CRM-197 conjugate vaccine, Children 2-23 months of age

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.

Interventions

BIOLOGICALMeningococcal quadrivalent CRM-197 conjugate vaccine

This study is strictly observational. Decisions of vaccination are made by health care providers.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 23 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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.
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
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.
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.

Countries

United States

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 details

Out of the 144 subjects enrolled, only 138 subjects were analysed in this study as 6 subjects did not meet the inclusion criteria.

Participants by arm

Arm	Count
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.	138
Total	138

Baseline characteristics

Characteristic	Exposure Group	—
Age, Continuous Age at first vaccination	11.5 Months STANDARD_DEVIATION 6.6	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Gender Female	70 Participants	—
Sex: Female, Male Gender Male	68 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 0
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination

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

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

Primary

Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

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

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

Arm	Measure	Group	Value (NUMBER)
Exposure Group	Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Hospitalization only	0.4 Events per person-year
Exposure Group	Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Emergency department only	0.6 Events per person-year
Exposure Group	Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Emergency department to hospital transfer	0.1 Events per person-year

Primary

Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination

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

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

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

Primary

Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

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

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

Arm	Measure	Group	Value (NUMBER)
Exposure Group	Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	ED and/or hospitalization encounters	102 Medical encounters
Exposure Group	Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Hospitalization only	32 Medical encounters
Exposure Group	Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Emergency department only	57 Medical encounters
Exposure Group	Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination	Emergency department to hospital transfer	13 Medical encounters

Primary

Number of Subjects Who Experienced Single or Multiple Medical Encounters

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Exposure Group	Number of Subjects Who Experienced Single or Multiple Medical Encounters	Single medical encounter	16 Participants
Exposure Group	Number of Subjects Who Experienced Single or Multiple Medical Encounters	Multiple medical encounters	24 Participants

Primary

Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses

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

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Exposure Group	Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses	Single medical diagnosis	6 Participants
Exposure Group	Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses	Multiple medical diganoses	34 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination

Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination

Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination

Number of Subjects Who Experienced Single or Multiple Medical Encounters

Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses