TABLE 1

Study Outcomes, Comparison Groups, and Analysis Methods Used in VSD's Active Vaccine-Safety Surveillance

Vaccine, Data Start DateAge Group, Gender (if Not Both)OutcomePostvaccination Observation Window, dComparison GroupaAnalysis MethodaPrimary Analysis
Population, Same Age; VSD Unless NotedAdjustment/Matching VariablesaYears
Menactra, May 1, 200511–19 yGBS1–42GBS hospital discharge diagnoses (including nonprimary) in the HCUP, person-timeAge group (11–14 and 15–19 y)2000–2004Poisson
Matched preventive care visitsbAge, gender, visit week, sitecConcurrentBinomial
11–17 yBell's palsy1–42Preventive care visitsbNone1991–2004 maximumdPoisson
Matched preventive care visitsbAge, gender, visit week, sitecConcurrentBinomial
Thrombocytopenia I1–42General person-timeNoneNot availablePoisson
Matched preventive care visitsbAge, gender, visit week, sitecConcurrentBinomial
Thrombocytopenia II1–42General person-timeNoneNot availablePoisson
Matched preventive care visitsbAge, gender, visit week, sitecConcurrentBinomial
Seizures0–42Matched preventive care visitsbAge, gender, visit week, sitecConcurrentBinomial
TdaP, Aug 7, 200510–64 yGBS1–42GBS hospital discharge diagnoses (including nonprimary) in the HCUP, person-timeAge group (10–14, 15–17, 18–26, 27–40, 41–50, and 51–64 y)2000–2004Poisson
Encephalopathy, encephalitis, meningitis1–42Td visitsAge group (10–17, 18–40, and 41–64 y), site2000–2004Poisson
Cranial nerve disorders1–42Td visitsAge group (10–17, 18–40, and 41–64 y), site2000–2004Poisson
Paralytic syndromes1–42Td visitsAge group (10–17, 18–40, and 41–64 y), site2000–2004Poisson
Seizures0–7Td visitsAge group (10–17, 18–40, and 41–64 y)2000–2004Poisson
MMRV, Feb 5, 200612–23 moAllergic reactions0–42MMR visitsSite2005–2006Poisson
Ataxia1–42MMR visitsSite2005–2006Poisson
Seizures0–42MMR visitsSite2005–2006Poisson
Meningitis and encephalitis1–42General person-timeNone2001–2006Poisson
Thrombocytopenia I1–42MMR visits (France et al16)None1991–2000Conditional Poisson
Thrombocytopenia II1–42MMR visits (France et al16), adjustedNone1991–2000Poisson
Arthritis1–42General person-timeNone1991–2004 maximumdPoisson
RotaTeq, May 21, 20064–52 wkIntussusception1–30General person-timeWeek of age, secular trend1991–2004 maximumdPoisson
Meningitis and encephalitis1–30General person-timeNone2000–2004Poisson
Myocarditis1–30General person-timeNone1991–2004 maximumdPoisson
Gram-negative sepsis1–30General person-timeNone1991–2004 maximumdPoisson
Seizures0–30General person-timeNone2000–2004Poisson
Gastrointestinal bleeding1–30Non-RotaTeq vaccine visitsWeek of age2000–2004Poisson
HPV vaccine, Aug 20, 2006e9–17 and 18–26 y, female (2 groups analyzed separately)GBS1–42GBS hospital discharge diagnoses (including nonprimary) in the HCUP, person-timeAge group (9–10, 11–14, 15–17, and 18–26 y)1991–2004Poisson
Matched preventive care visits without concomitant HPV vaccinebAge, visit week, siteConcurrentESAf
Appendicitis0–42General person-timeAge group (9–17 and 18–26 y), site2000–June 2006 maximumdPoisson
Matched preventive care visits without concomitant HPV vaccinebAge, visit week, siteConcurrentESAf
Stroke0–42General person-timeAge group (9–17 and 18–26 y), site1991–June 2006 maximum for 9- to 17-y-olds, 2000–June 2006, maximum for 18- to 26-y-oldsdPoisson
Matched preventive care visits without concomitant HPV vaccinebAge, visit week, siteConcurrentESAf
Venus thromboembolism1–42General person-timeAge group (9–13, 14–17, and 18–26 y)1991–June 2006 maximumdPoisson
Matched preventive care visits without concomitant HPV vaccinebAge, visit week, siteConcurrentESAf
Seizures0–42Matched preventive care visits without concomitant HPV vaccinebAge group (9–17 and 18–26 y), siteConcurrentESAf
Matched preventive care visits without concomitant HPV vaccinebAge, visit week, site1991–June–2006 maximum for 9- to 17-y-olds, 2000–June 2006 maximum for 18- to 26-y-oldsdPoisson
Syncope0Visits for Td, TdaP, meningococcal, or varicella vaccine without concomitant HPV vaccineAge (yrs)ConcurrentESAf
Visits for Td, TdaP, meningococcal, or varicella vaccine without concomitant HPV vaccineAge, visit week, site2004–June 2006Poisson
Allergic reactions0–2 for inpatient/emergency department; 1–2 for outpatientVisits for Td, TdaP, meningococcal, or varicella vaccine without concomitant HPV vaccineAge group (9–17 and 18–26 y)ConcurrentESAf
Visits for Td, TdaP, meningococcal, or varicella vaccine without concomitant HPV vaccineAge, visit week, site1991–June 2006 maximum for 9- to 17-y-olds, 2000–June 2006 maximum for 18- to 26-y-oldsdConditional Poisson
  • HCUP indicates the Healthcare Cost and Utilization Project (see www.hcup-us.ahrq.gov/overview.jsp); Td, tetanus and diphtheria toxoids vaccine.

  • a The comparison groups, adjustment variables, and analysis methods shown are those that were ultimately considered most appropriate and implemented, not necessarily those initially selected.

  • b Preventive care visits were defined as those with ICD-9 codes V20.2, V70.0, and V70.3 for Menactra and those with codes V20.2, V70.0, and V72.31 for HPV.

  • c When strict matching was not possible, matching rules were relaxed as described by Lieu et al.5

  • d The whole period was not available for all sites.

  • e All comparison groups are female only. The 9- to 17-year and 18- to 26-year age groups were analyzed separately but are collapsed here for convenience, with age group presented as an adjustment variable.

  • f ESA refers to exact sequential analysis, which allows for a variable number of matched controls per exposed person each week.