Table 2.
Description of Case-Control Studies of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Children Who Have Reported Data on PCV13 Effectiveness on Serotype 3 Invasive Pneumococcal Disease
| Study, Location | Design | Setting/Data Source | Study Period | PCV Use in Infant NIP | Definition/Identification of Cases | Definition/Identification of Controls | Adjustment or Matching of Cases and Controls | Ascertainment of Vaccination Status | Children Immunized With Lower Valent Vaccines Included in VE Analyses for Serotype 3 |
|---|---|---|---|---|---|---|---|---|---|
| Published studies | |||||||||
| Study 1, United States [6] |
Matched case-control | Population-based IPD surveillance system: ABCs | Jan 2010 to Dec 2014 | PCV7: 2000, 3 + 1 PCV13: 2010, 3 + 1 |
Children with IPD and resident of ABC site | 4 controls per case identified via state birth certificate registry | Controls matched for age and location | Medical record | No |
| Study 2, Spain [13] |
Matched case-control | 3 pediatric hospitals in Barcelona | Jan 2012 to June 2016 | See footnotea | Children hospitalized with IPD | 4 controls per case; patients admitted to same hospital as cases for cause other than IPD | Controls matched for age, sex, date of hospitalization, and underlying medical condition | Medical record | No |
| Study 3, Germany [14] | Indirect cohort | Voluntary national IPD surveillance system: German National Reference Center for Streptococci | July 2006 to June 2015 | PCV7: 2006, 3 + 1 PCV13: 2009, 3 + 1b |
Children with IPD reported to National Reference center. Cases = vaccine type IPD | Children with IPD reported to National Reference center. Controls = nonvaccine-type IPD | VE adjusted for age and time period | Questionnaire (diagnostic laboratory) | No |
| Study 4, United Kingdom [15] |
Indirect cohort | National IPD surveillance system: PHE | Apr 2010 to Oct 2013 | PCV7: 2006, 2 + 1 PCV13: 2010, 2 + 1 |
Children with IPD identified by national IPD surveillance system. Cases = vaccine type IPD | Children with IPD identified by national IPD surveillance system. Controls = nonvaccine-type IPD | VE adjusted for age and time period | Questionnaire (general practitioner) | Yes, PCV7 |
| Conference posters | |||||||||
| Study 5, European Union [24] |
Indirect cohort | Streptococcus pneumoniae invasive disease network | Jan 2012 to Dec 2014 | PCV7: 2009–2011,
2 + 1 or 3 + 1; PCV13: 2009–2010 2 + 1 or 3 + 1 |
Children with IPD identified by active surveillance system. Cases = vaccine type IPD | Children with IPD identified by active surveillance system. Controls = nonvaccine-type IPD | VE adjusted for site, age, sex, underlying conditions, and year of notification | Not reported | Not reported |
| Study 6, Canada [25] |
Unmatched case-controlc | Children residing in province of Quebec | 2005–2016 | PCV7: 2002, 2 + 1 or 3 + 1; PCV10: 2009, 2 + 1; PCV13: 2011, 2 + 1 | Children with IPD notified to regional public health authority | Children randomly selected in the Quebec Health Insurance Registry | VE adjusted for age, season, calendar year, and presence of high-risk medical conditions | Medical record | PCV7- or PCV10-immunized children considered “not vaccinated” |
Abbreviations: ABCs, active bacterial core surveillance; IPD, invasive pneumococcal disease; NIP, National Immunization Program; PCV, pneumococcal conjugate vaccine; PCV7, 7-valent pneumococcal conjugate vaccine; PCV10, 10-valent pneumococcal conjugate vaccine; PCV13, 13-valent pneumococcal conjugate vaccine; PHE, Public Health England; VE, vaccine effectiveness.
aThe Vaccination Advisory Committee of the Spanish Association of Pediatrics has recommended the routine administration of conjugate pneumococcal vaccines (PCV7 since 2003 to 2010 and, currently, PCV13, 2 + 1). These vaccines were not financed by the Catalan Public Health System until July 2016, except in children with selected risk factors, and were only available in the private sector. In Spain, the vaccine was not introduced into the recommended schedule until January 2017, and there are no estimates of vaccination coverage [13].
bPCV13 schedule changed to 2 + 1 in August 2015 except for preterm infants.
cControls were stratifed by age (2–5 months; 6–11 months; and 1, 2, 3, or 4 years of age).