Trial Outcomes & Findings for Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers (NCT NCT01128426)
NCT ID: NCT01128426
Last Updated: 2014-07-14
Results Overview
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Recruitment status
COMPLETED
Target enrollment
53902 participants
Primary outcome timeframe
30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)
Results posted on
2014-07-14
Participant Flow
Participant milestones
| Measure |
13vPnC
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
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|---|---|
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Overall Study
STARTED
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53902
|
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Overall Study
COMPLETED
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53902
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Baseline characteristics by cohort
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
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|---|---|
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Age, Continuous
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63 days
n=5 Participants
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Sex: Female, Male
Female
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26274 Participants
n=5 Participants
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Sex: Female, Male
Male
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27628 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Medically attended events documented retrospectively according to International Classification of Diseases, ninth Revision (ICD-9) coding.Medical attended event acute bronchiolitis due to Respiratory Syncytial Virus (RSV) has been represented as acute bronchiolitis due to RSV and acute pyelonephritis without renal medullary necrosis(RMN) lesion has been represented as acute pyelonephritis without RMN lesion in measure categories below.Results reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
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|---|---|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Abnormal involuntary movements
|
0.98 ratio
Interval 0.23 to 4.21
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Acute bronchiolitis due to RSV
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0.46 ratio
Interval 0.32 to 0.66
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Acute febrile mucocutaneous lymph node syndrome
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0.98 ratio
Interval 0.05 to 18.69
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Acute otitis media
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0.30 ratio
Interval 0.09 to 0.85
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Acute pyelonephritis without RMN lesion
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0.49 ratio
Interval 0.19 to 1.21
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Alkalosis
|
1.18 ratio
Interval 0.42 to 3.38
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Apnea
|
0.55 ratio
Interval 0.27 to 1.1
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Apparent life threatening event infant
|
0.45 ratio
Interval 0.24 to 0.82
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|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Asthma, unspecified, unspecified status
|
NA ratio
Interval 1.68 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Bronchiolitis
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0.51 ratio
Interval 0.29 to 0.89
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Bronchitis
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Bronchospasm
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NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Candidiasis of mouth
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0.53 ratio
Interval 0.24 to 1.14
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Cellulitis and abscess of trunk
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0.98 ratio
Interval 0.23 to 4.21
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Constipation
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0.25 ratio
Interval 0.02 to 1.46
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Croup
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NA ratio
Interval 1.68 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Dehydration
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0.49 ratio
Interval 0.3 to 0.8
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Dermatitis
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0.25 ratio
Interval 0.02 to 1.46
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Dyspnea
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0.68 ratio
Interval 0.32 to 1.4
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Failure to thrive
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0.87 ratio
Interval 0.49 to 1.55
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Fever
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0.28 ratio
Interval 0.17 to 0.45
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Fussy infant
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0.49 ratio
Interval 0.13 to 1.59
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Gastroenteritis
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NA ratio
Interval to 0.58
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Hypopotassemia
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0.66 ratio
Interval 0.12 to 3.21
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Lipoma of other specified sites
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NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Methicillin susceptible Staphylococcus aureus
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1.64 ratio
Interval 0.48 to 6.2
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Nausea and vomiting
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NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Neonatal bradycardia
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0.18 ratio
Interval 0.07 to 0.42
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Neonatal candida infection
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NA ratio
Interval to 0.58
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Other diseases of nasal cavity and sinuses
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0.49 ratio
Interval 0.16 to 1.35
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Other specified cardiac dysrhythmias
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0.98 ratio
Interval 0.4 to 2.44
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Pilonidal cyst without mention of abscess
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7.22 ratio
Interval 3.64 to 15.68
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Pneumonia
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0.41 ratio
Interval 0.16 to 0.97
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Primary apnea of newborn
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0.13 ratio
Interval 0.06 to 0.28
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Rash
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0.22 ratio
Interval 0.05 to 0.75
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Respiratory syncytial virus
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0.12 ratio
Interval 0.01 to 0.61
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Retinopathy of prematurity stage 2
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0.74 ratio
Interval 0.19 to 2.75
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Single seizure
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1.12 ratio
Interval 0.47 to 2.72
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Stridor
|
0.79 ratio
Interval 0.24 to 2.48
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Umbilical hernia without obstruction/gangrene
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0.49 ratio
Interval 0.26 to 0.9
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Unspecified bacterial pneumonia
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3.93 ratio
Interval 0.66 to 48.16
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Unspecified septicemia
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1.18 ratio
Interval 0.42 to 3.38
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Urinary tract infection
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0.23 ratio
Interval 0.12 to 0.43
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Viral syndrome
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0.41 ratio
Interval 0.19 to 0.84
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient
Weakness
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
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PRIMARY outcome
Timeframe: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for pre-dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
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|---|---|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Acute otitis media
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2.75 ratio
Interval 1.19 to 6.96
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Asthma, unspecified, unspecified status
|
0.74 ratio
Interval 0.19 to 2.75
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Bronchiolitis
|
0.82 ratio
Interval 0.57 to 1.17
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Bronchitis
|
0.33 ratio
Interval 0.03 to 2.2
|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Bronchospasm
|
2.95 ratio
Interval 0.79 to 14.4
|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Candidiasis of mouth
|
0.14 ratio
Interval 0.03 to 0.45
|
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Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Abnormal involuntary movements
|
1.97 ratio
Interval 0.23 to 28.51
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|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Acute bronchiolitis due to RSV
|
0.27 ratio
Interval 0.12 to 0.56
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|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Acute pyelonephritis without RMN lesion
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Adverse drug reaction
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Alkalosis
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Apnea
|
0.77 ratio
Interval 0.32 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Apparent life threatening event infant
|
0.72 ratio
Interval 0.37 to 1.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Asthma with acute exacerbation
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Constipation
|
0.36 ratio
Interval 0.17 to 0.7
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Croup
|
12.79 ratio
Interval 2.78 to 136.6
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Dehydration
|
0.84 ratio
Interval 0.32 to 2.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Dermatitis
|
0.36 ratio
Interval 0.12 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Dyspnea
|
0.77 ratio
Interval 0.45 to 1.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Failure to thrive
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Fever
|
0.57 ratio
Interval 0.48 to 0.68
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Fussy infant
|
0.67 ratio
Interval 0.48 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Gastroenteritis
|
0.82 ratio
Interval 0.29 to 2.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Hematoma
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Methicillin susceptible Staphylococcus aureus
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Nausea and vomiting
|
0.45 ratio
Interval 0.31 to 0.65
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Neonatal candida infection
|
0.18 ratio
Interval 0.04 to 0.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Other diseases of nasal cavity and sinuses
|
0.27 ratio
Interval 0.18 to 0.42
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Other specified cardiac dysrhythmias
|
NA ratio
Interval to 1.14
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Pneumonia
|
0.93 ratio
Interval 0.52 to 1.65
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Primary apnea of newborn
|
NA ratio
Interval to 1.14
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Rash
|
0.70 ratio
Interval 0.41 to 1.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Respiratory syncytial virus
|
1.12 ratio
Interval 0.47 to 2.72
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Single seizure
|
0.98 ratio
Interval 0.37 to 2.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Stomatitis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Stridor
|
NA ratio
Interval to 0.77
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Subconjunctival hemorrhage
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Umbilical hernia without obstruction/gangrene
|
0.14 ratio
Interval 0.03 to 0.45
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Unspecified septicemia
|
0.79 ratio
Interval 0.24 to 2.48
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Urinary tract infection
|
0.89 ratio
Interval 0.58 to 1.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Urticaria
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Vaccines adverse reaction
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Viral syndrome
|
0.83 ratio
Interval 0.51 to 1.34
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Weakness
|
0.49 ratio
Interval 0.03 to 4.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Emergency Department
Wheezing
|
0.84 ratio
Interval 0.32 to 2.16
|
PRIMARY outcome
Timeframe: 30 days before Dose 1 (-34 to -5 days before Dose 1, pre-vaccination self-control window for Dose 1), 30 days after Dose 1 (risk window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for pre-dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with self-control period occurring during 30 days before Dose 1 (pre-vaccination 30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Acute pyelonephritis without RMN lesion
|
0.49 ratio
Interval 0.19 to 1.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Pilonidal cyst without mention of abscess
|
7.22 ratio
Interval 3.64 to 15.68
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Abnormal involuntary movements
|
1.23 ratio
Interval 0.39 to 4.01
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Acute bronchiolitis due to RSV
|
0.45 ratio
Interval 0.32 to 0.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Acute febrile mucocutaneous lymph node syndrome
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Acute otitis media
|
1.19 ratio
Interval 0.66 to 2.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Adverse drug reaction
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Alkalosis
|
1.18 ratio
Interval 0.42 to 3.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Apnea
|
0.56 ratio
Interval 0.31 to 0.98
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Apparent life threatening event infant
|
0.51 ratio
Interval 0.3 to 0.84
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Asthma with acute exacerbation
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Asthma, unspecified, unspecified status
|
1.72 ratio
Interval 0.61 to 5.26
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Bronchiolitis
|
0.71 ratio
Interval 0.52 to 0.96
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Bronchitis
|
0.66 ratio
Interval 0.12 to 3.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Bronchospasm
|
1.97 ratio
Interval 0.61 to 7.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Candidiasis of mouth
|
0.37 ratio
Interval 0.19 to 0.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Cellulitis and abscess of trunk
|
0.98 ratio
Interval 0.23 to 4.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Constipation
|
0.34 ratio
Interval 0.17 to 0.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Croup
|
13.77 ratio
Interval 3.02 to 146.4
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Dehydration
|
0.55 ratio
Interval 0.35 to 0.86
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Dermatitis
|
0.35 ratio
Interval 0.14 to 0.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Dyspnea
|
0.78 ratio
Interval 0.5 to 1.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Failure to thrive
|
0.88 ratio
Interval 0.5 to 1.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Fever
|
0.57 ratio
Interval 0.48 to 0.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Fussy infant
|
0.64 ratio
Interval 0.46 to 0.87
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Gastroenteritis
|
0.45 ratio
Interval 0.17 to 1.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Hematoma
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Hypopotassemia
|
0.66 ratio
Interval 0.12 to 3.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Lipoma of other specified sites
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Methicillin susceptible Staphylococcus aureus
|
1.23 ratio
Interval 0.39 to 4.01
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Nausea and vomiting
|
0.45 ratio
Interval 0.31 to 0.65
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Neonatal bradycardia
|
0.18 ratio
Interval 0.07 to 0.42
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Neonatal candida infection
|
0.12 ratio
Interval 0.03 to 0.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Other diseases of nasal cavity and sinuses
|
0.30 ratio
Interval 0.2 to 0.44
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Other specified cardiac dysrhythmias
|
0.77 ratio
Interval 0.32 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Pneumonia
|
0.74 ratio
Interval 0.44 to 1.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Primary apnea of newborn
|
0.12 ratio
Interval 0.05 to 0.26
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Rash
|
0.57 ratio
Interval 0.35 to 0.91
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Respiratory syncytial virus
|
0.68 ratio
Interval 0.32 to 1.4
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Retinopathy of prematurity stage 2
|
0.74 ratio
Interval 0.19 to 2.75
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Single seizure
|
0.98 ratio
Interval 0.51 to 1.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Stomatitis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Stridor
|
0.49 ratio
Interval 0.16 to 1.35
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Subconjunctival hemorrhage
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Umbilical hernia without obstruction/gangrene
|
0.38 ratio
Interval 0.22 to 0.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Unspecified bacterial pneumonia
|
3.93 ratio
Interval 0.66 to 48.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Unspecified septicemia
|
1.09 ratio
Interval 0.51 to 2.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Urinary tract infection
|
0.59 ratio
Interval 0.41 to 0.85
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Urticaria
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Vaccines adverse reaction
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Viral syndrome
|
0.66 ratio
Interval 0.44 to 0.98
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Weakness
|
0.98 ratio
Interval 0.15 to 6.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Pre-Dose 1 Inpatient and Emergency Department Combined
Wheezing
|
0.84 ratio
Interval 0.32 to 2.16
|
PRIMARY outcome
Timeframe: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% (CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Methicillin susceptible Staphylococcus aureus
|
4.55 ratio
Interval 0.83 to 53.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Abnormal involuntary movements
|
NA ratio
Interval 0.79 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Acute bronchiolitis due to RSV
|
2.65 ratio
Interval 1.51 to 4.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Acute febrile mucocutaneous lymph node syndrome
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Acute otitis media
|
0.91 ratio
Interval 0.21 to 3.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Acute pyelonephritis without RMN lesion
|
1.14 ratio
Interval 0.36 to 3.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Alkalosis
|
NA ratio
Interval 1.95 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Apnea
|
2.73 ratio
Interval 0.93 to 9.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Apparent life threatening event infant
|
2.50 ratio
Interval 0.97 to 7.18
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Asthma, unspecified, unspecified status
|
NA ratio
Interval 1.56 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Bronchiolitis
|
1.69 ratio
Interval 0.78 to 3.81
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Bronchitis
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Candidiasis of mouth
|
6.37 ratio
Interval 1.26 to 71.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Cellulitis and abscess of trunk
|
2.73 ratio
Interval 0.41 to 35.48
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Constipation
|
0.30 ratio
Interval 0.02 to 2.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Croup
|
0.91 ratio
Interval 0.31 to 2.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Dehydration
|
1.11 ratio
Interval 0.61 to 2.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Dermatitis
|
0.46 ratio
Interval 0.03 to 3.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Dyspnea
|
2.05 ratio
Interval 0.77 to 6.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Failure to thrive
|
1.62 ratio
Interval 0.82 to 3.31
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Fever
|
1.95 ratio
Interval 0.92 to 4.32
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Fussy infant
|
2.73 ratio
Interval 0.41 to 35.48
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Gastroenteritis
|
NA ratio
Interval to 1.97
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Hypopotassemia
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Lipoma of other specified sites
|
0.46 ratio
Interval 0.03 to 3.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Nausea and vomiting
|
NA ratio
Interval to 8.19
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Neonatal bradycardia
|
NA ratio
Interval 1.17 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Other diseases of nasal cavity and sinuses
|
0.61 ratio
Interval 0.19 to 1.8
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Other specified cardiac dysrhythmias
|
3.19 ratio
Interval 0.88 to 15.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Pilonidal cyst without mention of abscess
|
2.36 ratio
Interval 1.48 to 3.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Pneumonia
|
0.91 ratio
Interval 0.31 to 2.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Primary apnea of newborn
|
NA ratio
Interval 1.56 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Rash
|
0.91 ratio
Interval 0.14 to 5.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Respiratory syncytial virus
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Retinopathy of prematurity stage 2
|
NA ratio
Interval 0.79 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Single seizure
|
0.66 ratio
Interval 0.3 to 1.43
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Stridor
|
0.91 ratio
Interval 0.26 to 3.13
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Umbilical hernia without obstruction/gangrene
|
2.50 ratio
Interval 0.97 to 7.18
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Unspecified bacterial pneumonia
|
NA ratio
Interval 1.17 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Unspecified septicemia
|
5.46 ratio
Interval 1.04 to 62.75
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Urinary tract infection
|
1.82 ratio
Interval 0.66 to 5.45
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Viral syndrome
|
1.06 ratio
Interval 0.41 to 2.77
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient
Weakness
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
PRIMARY outcome
Timeframe: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 1 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Subconjunctival hemorrhage
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Abnormal involuntary movements
|
0.61 ratio
Interval 0.11 to 2.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Acute bronchiolitis due to RSV
|
0.68 ratio
Interval 0.27 to 1.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Acute otitis media
|
0.61 ratio
Interval 0.34 to 1.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Adverse drug reaction
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Alkalosis
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Apnea
|
3.19 ratio
Interval 0.88 to 15.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Apparent life threatening event infant
|
2.50 ratio
Interval 0.97 to 7.18
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Asthma with acute exacerbation
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Asthma, unspecified, unspecified status
|
0.23 ratio
Interval 0.07 to 0.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Bronchiolitis
|
0.66 ratio
Interval 0.47 to 0.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Bronchitis
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Bronchospasm
|
0.61 ratio
Interval 0.24 to 1.46
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Candidiasis of mouth
|
1.82 ratio
Interval 0.21 to 26.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Constipation
|
0.73 ratio
Interval 0.32 to 1.61
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Croup
|
0.59 ratio
Interval 0.32 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Dehydration
|
0.61 ratio
Interval 0.24 to 1.46
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Dermatitis
|
0.26 ratio
Interval 0.09 to 0.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Dyspnea
|
1.49 ratio
Interval 0.79 to 2.86
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Failure to thrive
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Fever
|
1.38 ratio
Interval 1.11 to 1.72
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Fussy infant
|
1.19 ratio
Interval 0.81 to 1.77
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Gastroenteritis
|
0.76 ratio
Interval 0.26 to 2.12
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Hand, foot and mouth disease
|
NA ratio
Interval to 8.19
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Hematoma
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Nausea and vomiting
|
0.71 ratio
Interval 0.47 to 1.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Neonatal candida infection
|
1.82 ratio
Interval 0.21 to 26.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Other diseases of nasal cavity and sinuses
|
0.69 ratio
Interval 0.42 to 1.14
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Other specified cardiac dysrhythmias
|
NA ratio
Interval to 8.19
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Pneumonia
|
0.61 ratio
Interval 0.35 to 1.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Rash
|
0.97 ratio
Interval 0.54 to 1.73
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Respiratory syncytial virus
|
3.64 ratio
Interval 1.04 to 17.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Single seizure
|
0.91 ratio
Interval 0.34 to 2.45
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Stridor
|
NA ratio
Interval to 8.19
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Umbilical hernia without obstruction/gangrene
|
1.82 ratio
Interval 0.21 to 26.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Unspecified septicemia
|
1.82 ratio
Interval 0.42 to 9.58
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Urinary tract infection
|
3.30 ratio
Interval 1.74 to 6.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Urticaria
|
0.91 ratio
Interval 0.21 to 3.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Vaccines adverse reaction
|
NA ratio
Interval 0.79 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Viral syndrome
|
0.56 ratio
Interval 0.35 to 0.87
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Weakness
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Emergency Department
Wheezing
|
0.55 ratio
Interval 0.22 to 1.28
|
PRIMARY outcome
Timeframe: 30 days after Dose 1 (risk window for Dose 1), 30 days after risk window (post-dose self-control window for Dose 1)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 1 dose of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 1 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 1 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=53902 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Bronchitis
|
1.82 ratio
Interval 0.21 to 26.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Abnormal involuntary movements
|
1.52 ratio
Interval 0.44 to 5.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Acute bronchiolitis due to RSV
|
1.93 ratio
Interval 1.19 to 3.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Acute febrile mucocutaneous lymph node syndrome
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Acute otitis media
|
0.70 ratio
Interval 0.41 to 1.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Acute pyelonephritis without RMN lesion
|
1.14 ratio
Interval 0.36 to 3.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Adverse drug reaction
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Alkalosis
|
NA ratio
Interval 1.95 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Apnea
|
2.37 ratio
Interval 1.01 to 6.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Apparent life threatening event infant
|
2.43 ratio
Interval 1.12 to 5.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Asthma with acute exacerbation
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Asthma, unspecified, unspecified status
|
0.53 ratio
Interval 0.23 to 1.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Bronchiolitis
|
0.77 ratio
Interval 0.56 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Bronchospasm
|
0.61 ratio
Interval 0.24 to 1.46
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Candidiasis of mouth
|
4.10 ratio
Interval 1.2 to 18.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Cellulitis and abscess of trunk
|
2.73 ratio
Interval 0.41 to 35.48
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Constipation
|
0.63 ratio
Interval 0.3 to 1.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Croup
|
0.58 ratio
Interval 0.32 to 1.02
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Dehydration
|
1.00 ratio
Interval 0.6 to 1.68
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Dermatitis
|
0.28 ratio
Interval 0.11 to 0.65
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Dyspnea
|
1.58 ratio
Interval 0.93 to 2.73
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Failure to thrive
|
1.72 ratio
Interval 0.88 to 3.49
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Fever
|
1.39 ratio
Interval 1.13 to 1.73
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Fussy infant
|
1.21 ratio
Interval 0.83 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Gastroenteritis
|
0.57 ratio
Interval 0.21 to 1.47
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Hand, foot and mouth disease
|
NA ratio
Interval to 8.19
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Hematoma
|
0.91 ratio
Interval 0.05 to 17.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Hypopotassemia
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Lipoma of other specified sites
|
0.46 ratio
Interval 0.03 to 3.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Methicillin susceptible Staphylococcus aureus
|
4.55 ratio
Interval 0.83 to 53.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Nausea and vomiting
|
0.69 ratio
Interval 0.46 to 1.04
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Neonatal bradycardia
|
NA ratio
Interval 1.17 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Neonatal candida infection
|
1.82 ratio
Interval 0.21 to 26.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Other diseases of nasal cavity and sinuses
|
0.68 ratio
Interval 0.43 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Other specified cardiac dysrhythmias
|
3.19 ratio
Interval 0.88 to 15.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Pilonidal cyst without mention of abscess
|
2.36 ratio
Interval 1.48 to 3.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Pneumonia
|
0.56 ratio
Interval 0.34 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Primary apnea of newborn
|
NA ratio
Interval 1.56 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Rash
|
1.02 ratio
Interval 0.58 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Respiratory syncytial virus
|
2.73 ratio
Interval 0.93 to 9.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Retinopathy of prematurity stage 2
|
NA ratio
Interval 0.79 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Single seizure
|
0.85 ratio
Interval 0.44 to 1.61
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Stridor
|
0.73 ratio
Interval 0.22 to 2.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Subconjunctival hemorrhage
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Umbilical hernia without obstruction/gangrene
|
2.37 ratio
Interval 1.01 to 6.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Unspecified bacterial pneumonia
|
NA ratio
Interval 1.17 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Unspecified septicemia
|
3.03 ratio
Interval 1.06 to 10.3
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Urinary tract infection
|
2.73 ratio
Interval 1.56 to 4.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Urticaria
|
0.91 ratio
Interval 0.21 to 3.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Vaccines adverse reaction
|
NA ratio
Interval 0.79 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Viral syndrome
|
0.63 ratio
Interval 0.42 to 0.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Weakness
|
NA ratio
Interval 0.42 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 1 Inpatient and Emergency Department Combined
Wheezing
|
0.55 ratio
Interval 0.22 to 1.28
|
PRIMARY outcome
Timeframe: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=49230 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Other specified cardiac dysrhythmias
|
2.79 ratio
Interval 0.42 to 36.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Abnormal involuntary movements
|
4.65 ratio
Interval 0.84 to 54.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Acute bronchiolitis due to RSV
|
1.06 ratio
Interval 0.58 to 1.96
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Acute febrile mucocutaneous lymph node syndrome
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Acute otitis media
|
0.53 ratio
Interval 0.17 to 1.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Acute pyelonephritis without RMN lesion
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Alkalosis
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Apnea
|
NA ratio
Interval to 2.01
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Apparent life threatening event infant
|
0.23 ratio
Interval 0.02 to 1.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Asthma with acute exacerbation
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Asthma, unspecified, unspecified status
|
0.70 ratio
Interval 0.18 to 2.6
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Bronchiolitis
|
1.63 ratio
Interval 0.78 to 3.49
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Bronchitis
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Bronchospasm
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Cellulitis and abscess of trunk
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Constipation
|
2.79 ratio
Interval 0.42 to 36.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Croup
|
1.24 ratio
Interval 0.33 to 4.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Dehydration
|
1.01 ratio
Interval 0.5 to 2.05
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Dermatitis
|
1.86 ratio
Interval 0.43 to 9.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Dyspnea
|
0.93 ratio
Interval 0.27 to 3.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Failure to thrive
|
1.16 ratio
Interval 0.53 to 2.61
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Fever
|
0.93 ratio
Interval 0.31 to 2.77
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Fussy infant
|
NA ratio
Interval to 2.01
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Gastroenteritis
|
0.93 ratio
Interval 0.15 to 5.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Hypopotassemia
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Lipoma of other specified sites
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Methicillin susceptible Staphylococcus aureus
|
NA ratio
Interval 0.81 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Nausea and vomiting
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Other diseases of nasal cavity and sinuses
|
0.31 ratio
Interval 0.02 to 2.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Pilonidal cyst without mention of abscess
|
2.07 ratio
Interval 1.08 to 4.13
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Pneumonia
|
0.78 ratio
Interval 0.27 to 2.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Primary apnea of newborn
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Rash
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Retinopathy of prematurity stage 2
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Single seizure
|
0.47 ratio
Interval 0.09 to 1.99
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Stridor
|
3.72 ratio
Interval 0.63 to 45.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Umbilical hernia without obstruction/gangrene
|
3.72 ratio
Interval 0.63 to 45.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Unspecified bacterial pneumonia
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Unspecified septicemia
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Urinary tract infection
|
0.66 ratio
Interval 0.24 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Urticaria
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Viral syndrome
|
1.24 ratio
Interval 0.33 to 4.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient
Weakness
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
PRIMARY outcome
Timeframe: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 2 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=49230 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Gastroenteritis
|
1.05 ratio
Interval 0.59 to 1.86
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Hand, foot and mouth disease
|
1.86 ratio
Interval 0.22 to 26.96
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Bronchitis
|
1.16 ratio
Interval 0.37 to 3.79
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Bronchospasm
|
1.24 ratio
Interval 0.6 to 2.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Candidiasis of mouth
|
0.93 ratio
Interval 0.15 to 5.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Constipation
|
0.68 ratio
Interval 0.31 to 1.47
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Croup
|
0.87 ratio
Interval 0.6 to 1.24
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Dehydration
|
1.03 ratio
Interval 0.48 to 2.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Dermatitis
|
0.47 ratio
Interval 0.19 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Dyspnea
|
0.84 ratio
Interval 0.38 to 1.81
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Failure to thrive
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Fever
|
1.15 ratio
Interval 0.94 to 1.4
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Fussy infant
|
1.49 ratio
Interval 0.77 to 2.96
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Hematoma
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Nausea and vomiting
|
0.70 ratio
Interval 0.51 to 0.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Neonatal candida infection
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Other diseases of nasal cavity and sinuses
|
2.92 ratio
Interval 1.45 to 6.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Pneumonia
|
0.72 ratio
Interval 0.44 to 1.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Rash
|
0.73 ratio
Interval 0.41 to 1.3
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Respiratory syncytial virus
|
0.31 ratio
Interval 0.02 to 2.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Single seizure
|
1.40 ratio
Interval 0.58 to 3.48
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Stomatitis
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Stridor
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Subconjunctival hemorrhage
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Umbilical hernia without obstruction/gangrene
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Unspecified septicemia
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Urinary tract infection
|
1.20 ratio
Interval 0.71 to 2.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Urticaria
|
0.83 ratio
Interval 0.36 to 1.87
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Vaccines adverse reaction
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Viral syndrome
|
0.59 ratio
Interval 0.39 to 0.88
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Weakness
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Wheezing
|
0.80 ratio
Interval 0.47 to 1.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Abnormal involuntary movements
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Acute bronchiolitis due to RSV
|
2.79 ratio
Interval 1.21 to 7.0
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Acute otitis media
|
0.57 ratio
Interval 0.39 to 0.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Adverse drug reaction
|
0.93 ratio
Interval 0.15 to 5.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Apnea
|
NA ratio
Interval to 2.01
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Apparent life threatening event infant
|
0.31 ratio
Interval 0.02 to 2.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Asthma with acute exacerbation
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Asthma, unspecified, unspecified status
|
0.93 ratio
Interval 0.45 to 1.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Emergency Department
Bronchiolitis
|
0.84 ratio
Interval 0.62 to 1.14
|
PRIMARY outcome
Timeframe: 30 days after Dose 2 (risk window for Dose 2), 30 days after risk window (post-dose self-control window for Dose 2)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 2 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient and emergency department health care setting for Dose 2 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 2 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=49230 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Fussy infant
|
1.24 ratio
Interval 0.66 to 2.37
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Abnormal involuntary movements
|
6.51 ratio
Interval 1.29 to 73.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Acute bronchiolitis due to RSV
|
1.45 ratio
Interval 0.88 to 2.4
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Acute febrile mucocutaneous lymph node syndrome
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Acute otitis media
|
0.55 ratio
Interval 0.38 to 0.79
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Acute pyelonephritis without RMN lesion
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Adverse drug reaction
|
0.93 ratio
Interval 0.15 to 5.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Alkalosis
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Apnea
|
NA ratio
Interval to 0.72
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Apparent life threatening event infant
|
0.31 ratio
Interval 0.06 to 1.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Asthma with acute exacerbation
|
0.47 ratio
Interval 0.03 to 4.0
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Asthma, unspecified, unspecified status
|
0.81 ratio
Interval 0.43 to 1.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Bronchiolitis
|
0.86 ratio
Interval 0.65 to 1.15
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Bronchitis
|
1.12 ratio
Interval 0.4 to 3.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Bronchospasm
|
1.34 ratio
Interval 0.65 to 2.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Candidiasis of mouth
|
0.93 ratio
Interval 0.15 to 5.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Cellulitis and abscess of trunk
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Constipation
|
0.85 ratio
Interval 0.42 to 1.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Croup
|
0.87 ratio
Interval 0.61 to 1.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Dehydration
|
0.78 ratio
Interval 0.44 to 1.37
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Dermatitis
|
0.64 ratio
Interval 0.31 to 1.32
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Dyspnea
|
0.86 ratio
Interval 0.45 to 1.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Failure to thrive
|
1.16 ratio
Interval 0.53 to 2.61
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Fever
|
1.13 ratio
Interval 0.93 to 1.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Gastroenteritis
|
1.03 ratio
Interval 0.6 to 1.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Hand, foot and mouth disease
|
1.86 ratio
Interval 0.22 to 26.96
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Hematoma
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Hypopotassemia
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Lipoma of other specified sites
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Methicillin susceptible Staphylococcus aureus
|
NA ratio
Interval 0.81 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Nausea and vomiting
|
0.70 ratio
Interval 0.51 to 0.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Neonatal candida infection
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Other diseases of nasal cavity and sinuses
|
2.14 ratio
Interval 1.16 to 4.1
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Other specified cardiac dysrhythmias
|
2.79 ratio
Interval 0.42 to 36.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Pilonidal cyst without mention of abscess
|
2.07 ratio
Interval 1.08 to 4.13
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Pneumonia
|
0.77 ratio
Interval 0.49 to 1.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Primary apnea of newborn
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Rash
|
0.70 ratio
Interval 0.39 to 1.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Respiratory syncytial virus
|
0.31 ratio
Interval 0.02 to 2.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Retinopathy of prematurity stage 2
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Single seizure
|
0.84 ratio
Interval 0.38 to 1.81
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Stomatitis
|
NA ratio
Interval to 8.37
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Stridor
|
3.72 ratio
Interval 0.63 to 45.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Subconjunctival hemorrhage
|
NA ratio
Interval 0.43 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Umbilical hernia without obstruction/gangrene
|
4.65 ratio
Interval 0.84 to 54.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Unspecified bacterial pneumonia
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Unspecified septicemia
|
0.93 ratio
Interval 0.05 to 17.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Urinary tract infection
|
1.09 ratio
Interval 0.68 to 1.75
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Urticaria
|
0.74 ratio
Interval 0.33 to 1.64
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Vaccines adverse reaction
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Viral syndrome
|
0.61 ratio
Interval 0.42 to 0.9
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Weakness
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 2 Inpatient and Emergency Department Combined
Wheezing
|
0.80 ratio
Interval 0.47 to 1.36
|
PRIMARY outcome
Timeframe: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in inpatient health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Abnormal involuntary movements
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Acute bronchiolitis due to RSV
|
1.15 ratio
Interval 0.6 to 2.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Acute febrile mucocutaneous lymph node syndrome
|
NA ratio
Interval 1.68 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Acute otitis media
|
1.38 ratio
Interval 0.51 to 3.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Acute pyelonephritis without RMN lesion
|
2.95 ratio
Interval 0.44 to 38.33
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Alkalosis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Apnea
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Apparent life threatening event infant
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Asthma with acute exacerbation
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Asthma, unspecified, unspecified status
|
0.39 ratio
Interval 0.14 to 1.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Bronchiolitis
|
1.35 ratio
Interval 0.62 to 3.0
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Bronchitis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Candidiasis of mouth
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Cellulitis and abscess of trunk
|
NA ratio
Interval to 2.13
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Constipation
|
0.66 ratio
Interval 0.21 to 1.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Croup
|
1.48 ratio
Interval 0.3 to 8.32
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Dehydration
|
1.35 ratio
Interval 0.79 to 2.35
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Dermatitis
|
0.98 ratio
Interval 0.29 to 3.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Dyspnea
|
0.14 ratio
Interval 0.01 to 0.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Failure to thrive
|
1.15 ratio
Interval 0.45 to 2.99
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Fever
|
0.82 ratio
Interval 0.29 to 2.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Fussy infant
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Gastroenteritis
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Hand, foot and mouth disease
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Hypopotassemia
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Lipoma of other specified sites
|
0.33 ratio
Interval 0.03 to 2.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Methicillin susceptible Staphylococcus aureus
|
0.20 ratio
Interval 0.02 to 1.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Nausea and vomiting
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Other diseases of nasal cavity and sinuses
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Other specified cardiac dysrhythmias
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Pilonidal cyst without mention of abscess
|
0.86 ratio
Interval 0.36 to 2.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Pneumonia
|
1.11 ratio
Interval 0.49 to 2.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Rash
|
0.49 ratio
Interval 0.09 to 2.11
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Respiratory syncytial virus
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Single seizure
|
0.61 ratio
Interval 0.23 to 1.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Stridor
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Subconjunctival hemorrhage
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Umbilical hernia without obstruction/gangrene
|
1.97 ratio
Interval 0.23 to 28.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Unspecified bacterial pneumonia
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Unspecified septicemia
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Urinary tract infection
|
0.39 ratio
Interval 0.08 to 1.56
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Viral syndrome
|
0.25 ratio
Interval 0.02 to 1.46
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient
Wheezing
|
0.98 ratio
Interval 0.23 to 4.21
|
PRIMARY outcome
Timeframe: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). Relative risk in emergency department health care setting for Dose 3 was assessed by comparing the incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and its corresponding exact 2-sided 90% confidence CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Urinary tract infection
|
1.18 ratio
Interval 0.66 to 2.12
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Abnormal involuntary movements
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Acute bronchiolitis due to RSV
|
0.84 ratio
Interval 0.32 to 2.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Acute febrile mucocutaneous lymph node syndrome
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Acute otitis media
|
0.90 ratio
Interval 0.68 to 1.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Acute pyelonephritis without RMN lesion
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Adverse drug reaction
|
0.49 ratio
Interval 0.03 to 4.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Apnea
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Apparent life threatening event infant
|
NA ratio
Interval 0.11 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Asthma with acute exacerbation
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Asthma, unspecified, unspecified status
|
0.74 ratio
Interval 0.39 to 1.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Bronchiolitis
|
1.29 ratio
Interval 0.92 to 1.81
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Bronchitis
|
0.42 ratio
Interval 0.12 to 1.31
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Bronchospasm
|
1.97 ratio
Interval 0.92 to 4.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Candidiasis of mouth
|
0.25 ratio
Interval 0.02 to 1.46
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Cellulitis and abscess of trunk
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Constipation
|
1.09 ratio
Interval 0.51 to 2.38
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Croup
|
1.26 ratio
Interval 0.89 to 1.8
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Dehydration
|
1.12 ratio
Interval 0.69 to 1.85
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Dermatitis
|
1.97 ratio
Interval 0.72 to 5.89
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Dyspnea
|
2.62 ratio
Interval 0.87 to 9.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Failure to thrive
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Fever
|
1.07 ratio
Interval 0.9 to 1.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Fussy infant
|
0.84 ratio
Interval 0.43 to 1.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Gastroenteritis
|
0.51 ratio
Interval 0.28 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Hand, foot and mouth disease
|
1.31 ratio
Interval 0.35 to 5.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Hematoma
|
0.98 ratio
Interval 0.15 to 6.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Nausea and vomiting
|
1.12 ratio
Interval 0.85 to 1.5
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Neonatal candida infection
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Other diseases of nasal cavity and sinuses
|
0.91 ratio
Interval 0.48 to 1.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Other specified cardiac dysrhythmias
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Pneumonia
|
1.14 ratio
Interval 0.79 to 1.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Rash
|
0.66 ratio
Interval 0.35 to 1.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Respiratory syncytial virus
|
0.49 ratio
Interval 0.13 to 1.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Single seizure
|
1.15 ratio
Interval 0.45 to 2.99
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Stomatitis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Stridor
|
NA ratio
Interval 1.26 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Umbilical hernia without obstruction/gangrene
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Unspecified septicemia
|
NA ratio
Interval to 2.13
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Urticaria
|
0.98 ratio
Interval 0.46 to 2.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Viral syndrome
|
0.81 ratio
Interval 0.57 to 1.14
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Weakness
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Emergency Department
Wheezing
|
2.26 ratio
Interval 1.22 to 4.34
|
PRIMARY outcome
Timeframe: 30 days after Dose 3 (risk window for Dose 3), 30 days after risk window (post-dose self-control window for Dose 3)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window). Relative risk in inpatient and emergency department health care setting for Dose 3 was assessed by comparing the overall incidence rates of reported events in both settings per 1000 person-months occurring within 30 days after Dose 3 (30-day risk window) with the self-control period occurring during the subsequent 30 days (30-day self-control window). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Urticaria
|
0.98 ratio
Interval 0.46 to 2.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Hematoma
|
0.98 ratio
Interval 0.15 to 6.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Hypopotassemia
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Abnormal involuntary movements
|
2.95 ratio
Interval 0.44 to 38.33
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Acute bronchiolitis due to RSV
|
1.10 ratio
Interval 0.63 to 1.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Acute febrile mucocutaneous lymph node syndrome
|
4.92 ratio
Interval 0.89 to 57.98
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Acute otitis media
|
0.95 ratio
Interval 0.72 to 1.24
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Acute pyelonephritis without RMN lesion
|
3.93 ratio
Interval 0.66 to 48.16
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Adverse drug reaction
|
0.49 ratio
Interval 0.03 to 4.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Alkalosis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Apnea
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Apparent life threatening event infant
|
NA ratio
Interval 0.85 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Asthma with acute exacerbation
|
NA ratio
Interval 1.26 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Asthma, unspecified, unspecified status
|
0.63 ratio
Interval 0.37 to 1.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Bronchiolitis
|
1.33 ratio
Interval 0.97 to 1.85
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Bronchitis
|
0.37 ratio
Interval 0.11 to 1.11
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Bronchospasm
|
1.97 ratio
Interval 0.92 to 4.39
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Candidiasis of mouth
|
0.39 ratio
Interval 0.08 to 1.56
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Cellulitis and abscess of trunk
|
NA ratio
Interval to 1.14
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Constipation
|
0.85 ratio
Interval 0.45 to 1.6
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Croup
|
1.29 ratio
Interval 0.91 to 1.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Dehydration
|
1.13 ratio
Interval 0.77 to 1.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Dermatitis
|
1.69 ratio
Interval 0.77 to 3.84
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Dyspnea
|
0.79 ratio
Interval 0.35 to 1.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Failure to thrive
|
1.31 ratio
Interval 0.53 to 3.34
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Fever
|
1.05 ratio
Interval 0.88 to 1.25
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Fussy infant
|
0.85 ratio
Interval 0.45 to 1.6
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Gastroenteritis
|
0.64 ratio
Interval 0.37 to 1.11
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Hand, foot and mouth disease
|
1.64 ratio
Interval 0.48 to 6.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Lipoma of other specified sites
|
0.33 ratio
Interval 0.03 to 2.2
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Methicillin susceptible Staphylococcus aureus
|
0.20 ratio
Interval 0.02 to 1.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Nausea and vomiting
|
1.12 ratio
Interval 0.85 to 1.5
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Neonatal candida infection
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Other diseases of nasal cavity and sinuses
|
0.92 ratio
Interval 0.49 to 1.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Other specified cardiac dysrhythmias
|
2.95 ratio
Interval 0.44 to 38.34
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Pilonidal cyst without mention of abscess
|
0.86 ratio
Interval 0.36 to 2.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Pneumonia
|
1.10 ratio
Interval 0.77 to 1.58
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Rash
|
0.63 ratio
Interval 0.35 to 1.1
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Respiratory syncytial virus
|
0.42 ratio
Interval 0.12 to 1.31
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Single seizure
|
0.91 ratio
Interval 0.46 to 1.77
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Stomatitis
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Stridor
|
4.92 ratio
Interval 0.89 to 57.98
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Subconjunctival hemorrhage
|
NA ratio
Interval to 8.85
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Umbilical hernia without obstruction/gangrene
|
0.98 ratio
Interval 0.15 to 6.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Unspecified bacterial pneumonia
|
0.98 ratio
Interval 0.05 to 18.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Unspecified septicemia
|
NA ratio
Interval to 2.13
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Urinary tract infection
|
0.98 ratio
Interval 0.58 to 1.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Viral syndrome
|
0.76 ratio
Interval 0.54 to 1.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Weakness
|
NA ratio
Interval 0.45 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Dose 3 Inpatient and Emergency Department Combined
Wheezing
|
2.13 ratio
Interval 1.21 to 3.87
|
PRIMARY outcome
Timeframe: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in inpatient health care setting for primary series was assessed by comparing the combined incidence rate of reported events in inpatient setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Abnormal involuntary movements
|
4.69 ratio
Interval 1.4 to 21.45
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Acute bronchiolitis due to RSV
|
1.57 ratio
Interval 1.12 to 2.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Acute febrile mucocutaneous lymph node syndrome
|
3.29 ratio
Interval 0.91 to 15.67
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Acute otitis media
|
0.88 ratio
Interval 0.47 to 1.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Acute pyelonephritis without RMN lesion
|
1.88 ratio
Interval 0.76 to 4.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Alkalosis
|
6.57 ratio
Interval 1.3 to 74.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Apnea
|
1.56 ratio
Interval 0.67 to 3.84
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Apparent life threatening event infant
|
1.76 ratio
Interval 0.86 to 3.75
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Asthma with acute exacerbation
|
2.82 ratio
Interval 0.42 to 36.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Asthma, unspecified, unspecified status
|
0.80 ratio
Interval 0.41 to 1.55
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Bronchiolitis
|
1.55 ratio
Interval 1.01 to 2.42
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Bronchitis
|
0.94 ratio
Interval 0.15 to 6.0
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Bronchospasm
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Candidiasis of mouth
|
4.22 ratio
Interval 1.23 to 19.53
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Cellulitis and abscess of trunk
|
0.94 ratio
Interval 0.27 to 3.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Constipation
|
0.75 ratio
Interval 0.33 to 1.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Croup
|
1.13 ratio
Interval 0.55 to 2.33
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Dehydration
|
1.17 ratio
Interval 0.83 to 1.65
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Dermatitis
|
1.06 ratio
Interval 0.47 to 2.41
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Dyspnea
|
0.88 ratio
Interval 0.47 to 1.63
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Failure to thrive
|
1.35 ratio
Interval 0.86 to 2.12
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Fever
|
1.30 ratio
Interval 0.78 to 2.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Fussy infant
|
0.94 ratio
Interval 0.27 to 3.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Gastroenteritis
|
1.17 ratio
Interval 0.37 to 3.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Hand, foot and mouth disease
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Hypopotassemia
|
NA ratio
Interval 1.61 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Lipoma of other specified sites
|
0.75 ratio
Interval 0.23 to 2.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Methicillin susceptible Staphylococcus aureus
|
1.41 ratio
Interval 0.59 to 3.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Nausea and vomiting
|
0.47 ratio
Interval 0.03 to 4.04
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Neonatal bradycardia
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Other diseases of nasal cavity and sinuses
|
0.56 ratio
Interval 0.23 to 1.32
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Other specified cardiac dysrhythmias
|
2.82 ratio
Interval 1.11 to 8.0
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Pilonidal cyst without mention of abscess
|
1.96 ratio
Interval 1.4 to 2.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Pneumonia
|
0.94 ratio
Interval 0.55 to 1.61
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Primary apnea of newborn
|
NA ratio
Interval 2.01 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Rash
|
0.54 ratio
Interval 0.18 to 1.52
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Respiratory syncytial virus
|
0.47 ratio
Interval 0.03 to 4.04
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Retinopathy of prematurity stage 2
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Single seizure
|
0.61 ratio
Interval 0.35 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Stridor
|
1.41 ratio
Interval 0.59 to 3.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Subconjunctival hemorrhage
|
NA ratio
Interval to 8.45
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Umbilical hernia without obstruction/gangrene
|
2.66 ratio
Interval 1.24 to 6.14
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Unspecified bacterial pneumonia
|
2.82 ratio
Interval 0.75 to 13.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Unspecified septicemia
|
2.19 ratio
Interval 0.71 to 7.8
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Urinary tract infection
|
0.88 ratio
Interval 0.48 to 1.6
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Urticaria
|
NA ratio
Interval to 8.45
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Viral syndrome
|
0.87 ratio
Interval 0.44 to 1.69
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Weakness
|
NA ratio
Interval 0.81 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient
Wheezing
|
0.94 ratio
Interval 0.22 to 4.02
|
PRIMARY outcome
Timeframe: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in emergency department setting per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Acute otitis media
|
0.73 ratio
Interval 0.59 to 0.89
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Abnormal involuntary movements
|
1.56 ratio
Interval 0.46 to 5.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Acute bronchiolitis due to RSV
|
1.27 ratio
Interval 0.78 to 2.08
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Acute febrile mucocutaneous lymph node syndrome
|
NA ratio
Interval to 8.45
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Acute pyelonephritis without RMN lesion
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Adverse drug reaction
|
0.94 ratio
Interval 0.27 to 3.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Alkalosis
|
NA ratio
Interval 0.1 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Apnea
|
1.88 ratio
Interval 0.68 to 5.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Apparent life threatening event infant
|
1.74 ratio
Interval 0.81 to 3.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Asthma with acute exacerbation
|
2.82 ratio
Interval 0.42 to 36.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Asthma, unspecified, unspecified status
|
0.63 ratio
Interval 0.41 to 0.95
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Bronchiolitis
|
0.89 ratio
Interval 0.74 to 1.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Bronchitis
|
0.70 ratio
Interval 0.33 to 1.47
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Bronchospasm
|
1.20 ratio
Interval 0.77 to 1.88
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Candidiasis of mouth
|
0.67 ratio
Interval 0.24 to 1.79
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Cellulitis and abscess of trunk
|
NA ratio
Interval to 8.45
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Constipation
|
0.81 ratio
Interval 0.52 to 1.27
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Croup
|
0.95 ratio
Interval 0.75 to 1.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Dehydration
|
0.96 ratio
Interval 0.66 to 1.4
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Dermatitis
|
0.56 ratio
Interval 0.34 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Dyspnea
|
1.37 ratio
Interval 0.89 to 2.13
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Failure to thrive
|
3.76 ratio
Interval 0.63 to 45.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Fever
|
1.17 ratio
Interval 1.04 to 1.31
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Fussy infant
|
1.17 ratio
Interval 0.87 to 1.58
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Gastroenteritis
|
0.73 ratio
Interval 0.5 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Hand, foot and mouth disease
|
1.13 ratio
Interval 0.4 to 3.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Hematoma
|
0.70 ratio
Interval 0.18 to 2.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Nausea and vomiting
|
0.86 ratio
Interval 0.71 to 1.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Neonatal candida infection
|
5.63 ratio
Interval 1.07 to 64.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Other diseases of nasal cavity and sinuses
|
1.10 ratio
Interval 0.79 to 1.54
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Other specified cardiac dysrhythmias
|
1.88 ratio
Interval 0.22 to 27.21
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Pneumonia
|
0.85 ratio
Interval 0.66 to 1.1
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Rash
|
0.78 ratio
Interval 0.56 to 1.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Respiratory syncytial virus
|
1.02 ratio
Interval 0.51 to 2.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Single seizure
|
1.15 ratio
Interval 0.68 to 1.95
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Stomatitis
|
NA ratio
Interval to 2.03
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Stridor
|
4.69 ratio
Interval 0.85 to 55.34
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Subconjunctival hemorrhage
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Umbilical hernia without obstruction/gangrene
|
1.41 ratio
Interval 0.29 to 7.94
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Unspecified septicemia
|
0.75 ratio
Interval 0.23 to 2.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Urinary tract infection
|
1.62 ratio
Interval 1.17 to 2.26
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Urticaria
|
0.90 ratio
Interval 0.54 to 1.49
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Vaccines adverse reaction
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Viral syndrome
|
0.66 ratio
Interval 0.52 to 0.82
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Weakness
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Emergency Department
Wheezing
|
1.08 ratio
Interval 0.76 to 1.53
|
PRIMARY outcome
Timeframe: 30 days after Dose 1, 2, 3 combined (risk window for primary series), 30 days after risk window for Dose 1, 2, 3 combined (post-dose self-control window for primary series)Population: Analysis population included participants who started vaccination with 13vPnC within the first 6 months of life, were members of KPNC and received at least 3 doses of 13vPnC vaccine during the study observation period.
Relative risk for given event = incidence rate (risk window) / incidence rate (self-control window). For primary series (Dose 1, 2, 3 combined), all 30-day risk windows and all post-dose 30-day control windows were summed. Relative risk in in inpatient and emergency department health care setting for primary series was assessed by comparing the combined incidence rate of reported events in both the settings per 1000 person-months occurring within 30 days after Dose 1, 2, and 3 (risk window) with the combined self-control period occurring during the subsequent 30 days for each dose (self-control windows after risk window for each dose). Relative risk and exact 2-sided 90% CIs were reported. Medically attended events were documented retrospectively according to ICD-9 coding. Results were reported for events reported in either of the windows.
Outcome measures
| Measure |
13vPnC
n=44178 Participants
Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
|
|---|---|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Abnormal involuntary movements
|
2.82 ratio
Interval 1.23 to 7.07
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Acute bronchiolitis due to RSV
|
1.50 ratio
Interval 1.12 to 2.01
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Acute febrile mucocutaneous lymph node syndrome
|
2.19 ratio
Interval 0.71 to 7.8
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Acute otitis media
|
0.75 ratio
Interval 0.62 to 0.92
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Acute pyelonephritis without RMN lesion
|
2.07 ratio
Interval 0.86 to 5.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Adverse drug reaction
|
0.94 ratio
Interval 0.27 to 3.23
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Alkalosis
|
6.57 ratio
Interval 1.3 to 74.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Apnea
|
1.31 ratio
Interval 0.66 to 2.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Apparent life threatening event infant
|
1.64 ratio
Interval 0.91 to 3.04
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Asthma with acute exacerbation
|
2.82 ratio
Interval 0.75 to 13.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Asthma, unspecified, unspecified status
|
0.65 ratio
Interval 0.45 to 0.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Bronchiolitis
|
0.95 ratio
Interval 0.8 to 1.13
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Bronchitis
|
0.74 ratio
Interval 0.37 to 1.44
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Bronchospasm
|
1.24 ratio
Interval 0.8 to 1.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Candidiasis of mouth
|
1.36 ratio
Interval 0.66 to 2.84
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Cellulitis and abscess of trunk
|
0.75 ratio
Interval 0.23 to 2.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Constipation
|
0.77 ratio
Interval 0.52 to 1.14
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Croup
|
0.95 ratio
Interval 0.76 to 1.19
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Dehydration
|
0.99 ratio
Interval 0.76 to 1.3
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Dermatitis
|
0.68 ratio
Interval 0.44 to 1.04
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Dyspnea
|
1.13 ratio
Interval 0.79 to 1.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Failure to thrive
|
1.43 ratio
Interval 0.92 to 2.24
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Fever
|
1.16 ratio
Interval 1.03 to 1.29
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Fussy infant
|
1.14 ratio
Interval 0.86 to 1.52
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Gastroenteritis
|
0.77 ratio
Interval 0.54 to 1.09
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Hand, foot and mouth disease
|
1.31 ratio
Interval 0.49 to 3.66
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Hematoma
|
0.70 ratio
Interval 0.18 to 2.62
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Hypopotassemia
|
NA ratio
Interval 1.61 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Lipoma of other specified sites
|
0.75 ratio
Interval 0.23 to 2.36
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Methicillin susceptible Staphylococcus aureus
|
1.41 ratio
Interval 0.59 to 3.51
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Nausea and vomiting
|
0.85 ratio
Interval 0.71 to 1.03
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Neonatal bradycardia
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Neonatal candida infection
|
5.63 ratio
Interval 1.07 to 64.71
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Other diseases of nasal cavity and sinuses
|
1.01 ratio
Interval 0.74 to 1.37
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Other specified cardiac dysrhythmias
|
3.05 ratio
Interval 1.22 to 8.59
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Pilonidal cyst without mention of abscess
|
1.96 ratio
Interval 1.4 to 2.78
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Pneumonia
|
0.83 ratio
Interval 0.66 to 1.06
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Primary apnea of newborn
|
NA ratio
Interval 2.01 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Rash
|
0.76 ratio
Interval 0.55 to 1.05
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Respiratory syncytial virus
|
0.94 ratio
Interval 0.49 to 1.81
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Retinopathy of prematurity stage 2
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Single seizure
|
0.86 ratio
Interval 0.58 to 1.28
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Stomatitis
|
NA ratio
Interval to 2.03
Relative risk and lower CI was not estimated because no event was reported during the 30-day risk window.
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Stridor
|
1.74 ratio
Interval 0.81 to 3.93
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Subconjunctival hemorrhage
|
3.76 ratio
Interval 0.63 to 45.97
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Umbilical hernia without obstruction/gangrene
|
2.35 ratio
Interval 1.19 to 4.85
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Unspecified bacterial pneumonia
|
2.82 ratio
Interval 0.75 to 13.74
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Unspecified septicemia
|
1.72 ratio
Interval 0.75 to 4.17
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Urinary tract infection
|
1.39 ratio
Interval 1.04 to 1.86
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Urticaria
|
0.86 ratio
Interval 0.52 to 1.41
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Vaccines adverse reaction
|
NA ratio
Interval 1.21 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Viral syndrome
|
0.67 ratio
Interval 0.54 to 0.83
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Weakness
|
NA ratio
Interval 1.61 to
Relative risk and upper CI was not estimated because no event was reported during the 30-day self-control window
|
|
Relative Risk of Medically Attended Events Between 30-day Risk Window and 30-day Self-control Window: Primary Series Inpatient and Emergency Department Combined
Wheezing
|
1.09 ratio
Interval 0.77 to 1.54
|
Adverse Events
13vPnC
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 Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER