Trial Outcomes & Findings for Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study (NCT NCT02287688)
NCT ID: NCT02287688
Last Updated: 2019-10-21
Results Overview
The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported
Recruitment status
COMPLETED
Target enrollment
144 participants
Primary outcome timeframe
Within 6 months after any dose of MenACWY-CRM vaccination
Results posted on
2019-10-21
Participant Flow
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.
Out of the 144 subjects enrolled, only 138 subjects were analysed in this study as 6 subjects did not meet the inclusion criteria.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
138
|
|
Overall Study
COMPLETED
|
138
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Age, Continuous
Age at first vaccination
|
11.5 Months
STANDARD_DEVIATION 6.6 • n=138 Participants
|
|
Sex: Female, Male
Gender · Female
|
70 Participants
n=138 Participants
|
|
Sex: Female, Male
Gender · Male
|
68 Participants
n=138 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRM vaccinationPopulation: Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.
The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Number of Subjects Who Experienced Single or Multiple Medical Encounters
Single medical encounter
|
16 Participants
|
|
Number of Subjects Who Experienced Single or Multiple Medical Encounters
Multiple medical encounters
|
24 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRMPopulation: Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.
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.
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
ED and/or hospitalization encounters
|
102 Medical encounters
|
|
Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Hospitalization only
|
32 Medical encounters
|
|
Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Emergency department only
|
57 Medical encounters
|
|
Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Emergency department to hospital transfer
|
13 Medical encounters
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRMPopulation: Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.
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.
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Hospitalization only
|
0.4 Events per person-year
Interval 0.3 to 0.5
|
|
Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Emergency department only
|
0.6 Events per person-year
Interval 0.5 to 0.8
|
|
Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination
Emergency department to hospital transfer
|
0.1 Events per person-year
Interval 0.1 to 0.3
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRMPopulation: Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.
Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses
Single medical diagnosis
|
6 Participants
|
|
Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses
Multiple medical diganoses
|
34 Participants
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRMPopulation: Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.
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.
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Unspecified otitis media(382.9)
|
6 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Splenomegaly(789.2)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute upper respiratory infections(465.9)
|
10 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute bronchitis(466.0)
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute bronchiolitis,RSV(466.11)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute bronchiolitis,other organisms(466.19)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Chronic rhinitis(472.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia, parainfluenza virus(480.2)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia,other virus not classified(480.8)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumococcal pneumonia(481)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia, Pseudomonas(482.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia, other gram-negative bacteria(482.83)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia, mycoplasma pneumoniae(483.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Intestinal infection, other organism (ICD-008.8)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Septicemia, pseudomonas (038.43)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pseudomonas infection (041.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other specified bacterial infections(041.85)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Viral exanthem, unspecified(057.9)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Adenovirus infection(079.0)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Rhinovirus infection(079.3)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other specified viral infection(079.89)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Unspecified viral infection(079.99)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Candidiasis of mouth(112.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Hyposmolality and/or hyponatremia(276.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acidosis(276.2)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Dehydration(276.51)
|
6 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Hyperpotassemia(276.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Hb-SS disease with crisis(282.62)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other pancytopenia(284.19)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute posthemorrhagic anemia(285.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Anemia, unspecified(285.9)
|
4 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Leukocytosis, unspecified(288.60)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other specified delays in development(315.8)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Cerebral degeneration(331.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Epilepsy, unspecified(345.90)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Encephalopathy, unspecified(348.30)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Cerebral edema(348.5)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Conjunctivitis, unspecified(372.30)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Redness or discharge of eye(379.93)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pneumonia, organism unspecified(486)
|
5 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Influenza-other respiratory manifestations(487.1)
|
4 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Asthma, unspecified type, unspecified(493.90)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Effusion, other (except tuberculous)(511.89)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pulmonary congestion and hypostasis(514)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Cardiomegaly(429.3)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Unspecified pneumonopathy(516.9
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Subdural hemorrhage(432.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pulmonary collapse(518.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Cerebral artery occlusion(434.91)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute venous embolism and thrombosis(453.41)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute sinusitis, unspecified(461.9)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Acute respiratory failure(518.81)
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other pulmonary insufficiency(518.82)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other gastrostomy complications(536.49)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other disorders-stomach & duodenum(537.89)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Noninfectious gastroenteritis &colitis,other(558.9
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Constipation, unspecified(564.00)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Anal sphincter tear (healed) (old)(569.43)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Urinary tract infection, site not specified(599.0)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Microscopic hematuria(599.72)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Diaper or napkin rash(691.0)
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Allergic urticaria(708.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pain in joint, lower leg(719.46)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Pain in limb(729.5)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Swelling of limb(729.81)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other anomalies of great veins(747.49)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other anomalies of female genitalia(752.49)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Anomalies of skull and face bones(756.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Hypoxicischemic encephalopathy,unspecified(768.70)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Complex febrile convulsions(780.32)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other convulsions(780.39)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Fever, unspecified(780.60)
|
25 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Fever with conditions classified elsewhere(780.61)
|
11 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Postvaccination fever(780.63)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Altered mental status(780.97)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Rash & other nonspecific skin eruption(782.1)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Feeding difficulties & mismanagement(783.3)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Tachycardia, unspecified(785.0)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Tachypnea(786.06)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Wheezing(786.07)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other respiratory abnormalities(786.09)
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Cough(786.2)
|
5 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Abnormal chest sounds(786.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Nausea with vomiting(787.01)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Vomiting alone(787.03)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Flatulence,eructation & gas pain(787.3)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Diarrhea(787.91)
|
4 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other symptoms involving digestive system(787.99)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Bacteremia(790.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Viremia, unspecified(790.8)
|
5 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other abnormal finding of lung field(793.19)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Abnormal results,pulmonary function(794.2)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Hypoxemia(799.02)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Subarachnoid hemorrhage following injury(852.00)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Subdural hemorrhage following injury(852.2)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Subdural hemorrhage unspecified(852.20)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Open wound of finger(s)(883.0)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Insect bite,nonvenomous of lower limb(916.4)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Contusion of chest wall(922.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Foreign body in digestive system,unspecified(938)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Head injury, unspecified(959.01)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Knee, leg, ankle, and foot injury(959.7)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Child abuse, unspecified(995.50)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Child physical abuse(995.54)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Vascular device,implant,graft,complications(996.74
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Body systems,complications,hypertension(997.91)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other external cause status(E000.8)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other activity(E029.9)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Traffic accident-passenger injury(E812.1)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Home accidents(E849.0)
|
2 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Accidents occurring in unspecified place(E849.9)
|
3 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Surgical operations & procedures, (E878.8)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other procedures, complication(E879.8)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Accidental fall on/from other stairs/steps(E880.9)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Unspecified fall(E888.9)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Bite of nonvenomous arthropod(E906.4)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Accidents caused by cutting and piercing(E920.8)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Other accidents(E928.8)
|
1 Medical diagnoses
|
|
Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination
Unspecified accident(E928.9)
|
1 Medical diagnoses
|
PRIMARY outcome
Timeframe: Within 6 months after any dose of MenACWY-CRMPopulation: 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.
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.
Outcome measures
| Measure |
Exposure Group
n=138 Participants
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.
|
|---|---|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other symptoms-digestive system(787.99)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Splenomegaly(789.2)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Bacteremia(790.7)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Viremia,unspecified(790.8)
|
0.1 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Hypoxemia(799.02)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Subarachnoid hemorrhage,consciousness(852.00)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Subdural hemorrhage following injury(852.2)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Subdural hemorrhage,consciousness(852.20)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Contusion of chest wall(922.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other disorders-stomach & duodenum(537.89)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Noninfectious gastroenteritis&colitis,other(558.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Constipation, unspecified(564.00)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Microscopic hematuria(599.72)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Diaper or napkin rash(691.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Allergic urticaria(708.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pain in limb(729.5)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Swelling of limb(729.81)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Hypoxicischemic encephalopathy,unspecified(768.70)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Complex febrile convulsions(780.32)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other convulsions(780.39)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Fever, unspecified(780.60)
|
0.3 Events per person-year
Interval 0.2 to 0.4
|
|
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
Interval 0.1 to 0.2
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Postvaccination fever(780.63)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Altered mental status(780.97)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Feeding difficulties & mismanagement(783.3)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Tachycardia,unspecified(785.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Tachypnea(786.06)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Wheezing(786.07)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other respiratory abnormalities(786.09)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Cough(786.2)
|
0.1 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Abnormal chest sounds(786.7)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Nausea with vomiting(787.01)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Vomiting alone(787.03)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Flatulence, eructation & gas pain(787.3)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Diarrhea(787.91)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Head injury, unspecified(959.01)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Child abuse, unspecified(995.50)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Child physical abuse(995.54)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Body systems,hypertension,complications(997.91)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other external cause status(E000.8)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other activity(E029.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Traffic accident-passenger injury(E812.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Home accidents(E849.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Surgical operations & procedures(E878.8)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Specified procedures, complications(E879.8)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Unspecified fall(E888.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Bite of nonvenomous arthropod(E906.4)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other accidents(E928.8)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Unspecified accident(E928.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Septicemia, pseudomonas (038.43)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pseudomonas infection(041.7)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other specified bacterial infections(041.85)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Viral exanthem, unspecified(057.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Adenovirus infection(079.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Rhinovirus infection(079.3)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other specified viral infection(079.89)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Unspecified viral infection(079.99)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Candidiasis of mouth(112.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Hyposmolality and/or hyponatremia(276.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acidosis(276.2)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Dehydration(276.51)
|
0.1 Events per person-year
Interval 0.0 to 0.2
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Hyperpotassemia(276.7)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other pancytopenia(284.19)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute posthemorrhagic anemia(285.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Anemia, unspecified(285.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Leukocytosis, unspecified(288.60)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Cerebral degeneration(331.7)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Epilepsy, unspecified(345.90)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Encephalopathy, unspecified(348.30)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Cerebral edema(348.5)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Conjunctivitis, unspecified(372.30)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
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
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Unspecified otitis media(382.9)
|
0.1 Events per person-year
Interval 0.0 to 0.2
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Cardiomegaly(429.3)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Subdural hemorrhage(432.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Cerebral artery occlusion(434.91)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute venous embolism & thrombosis(453.41)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute sinusitis, unspecified(461.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute upper respiratory infections(465.9)
|
0.1 Events per person-year
Interval 0.1 to 0.2
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute bronchitis(466.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute bronchiolitis, RSV(466.11)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute bronchiolitis, other organisms(466.19)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Chronic rhinitis(472.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia-parainfluenza virus(480.2)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia, other virus(480.8)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumococcal pneumonia(481)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia, Pseudomonas(482.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia, gram-negative bacteria(482.83)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia, mycoplasma pneumoniae(483.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pneumonia, organism unspecified(486)
|
0.1 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Influenza-other respiratory manifestations(487.1)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Asthma,unspecified type,unspecified(493.90)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Effusion,other except tuberculous(511.89)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pulmonary congestion & hypostasis(514)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Parieto/alveolar pneumonopathy,other(516.9)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Pulmonary collapse(518.0)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Acute respiratory failure(518.81)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other pulmonary insufficiency(518.82)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
|
Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination
Other gastrostomy complications(536.49)
|
0.0 Events per person-year
Interval 0.0 to 0.1
|
Adverse Events
Exposure Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER