Table 2. Characteristics of studies included in the systematic review of PPV23 efficacy/effectiveness.
| Publication | Study type | Country | Study population | Number of vaccinated/unvaccinated | Period of follow-up observation | Sponsor | Risk of bias | Inclusion for endpoints IPD/PP |
|---|---|---|---|---|---|---|---|---|
| Alfageme 2006 [18] | RCT | Spain | COPD patients; median age vaccine group 69, unvaccinated group 68, range 61–73 years | 298/298 | 2.7 years | Spanish Pneumology Society, Andalusian Health Service | Low | Y/Y |
| Maruyama 2010 [19] | RCT | Japan | Nursing home residents; mean age vaccine group 84.7, placebo group 84.8, range 55–105 years | 502/504 | 2.3 years | Japanese Ministry of Education, Culture, Sports, Science, and Technology | Low | Y/Y |
| Örtqvist 1998 [20] | RCT | Sweden | Former CAP patients; mean age vaccine group 69.4, placebo group 69.1, range 50–85 years | 339/352 | 2.4 years | Pasteur-Mérieux MSD, Swedish Heart-Lung Foundation, Karolinska Institute | Low a | Y/Na |
| Honkanen 1999 [21] | (RCT) b | Finland | Resident population aged ≥65 years; mean age vaccine group 73.3, unvaccinated group 73.7 years | 13,980/12,945 | 1.4 years | Academy of Finland, Pasteur-Mérieux | Uncleara | Y/Na |
| Hechter 2012 [25] | Cohort | USA | Participants of the longitudinal California Men's Health Study, aged ≥60 years | 7,718/9,232 at study begin | Variable | Kaiser Permanente Southern California | High | Y/Nc |
| Jackson 2003 [24] | Cohort | USA | Resident population, aged ≥65 years | 42,977/84,203 (PY) | Variable (81% 5–8 years) | CDC (USA) | Low | Y/Nc |
| Ochoa-Gondar 2014 [22] | Cohort | Spain | Resident population, aged ≥60 years | 29,065/46,968 (PY) | up to 5 years | Spanish Health Ministry | Low | Y/Y |
| Tsai 2015 [26] | Cohort | Taiwan | Resident population, aged ≥75 years | 229,181/229,181 | 1 year | Taiwan CDC | High | Y/Nc |
| Vila-Corcoles 2006 [23] | Cohort | Spain | Resident population, aged ≥65 years | 17,401/16,504 (PY) | Variable (87% 2–5 years) | Spanish Health Ministry | Low | Y/Y |
| Cases/Controls | ||||||||
| Dominguez 2005 [27] | Case-control | Spain | VT IPD cases ≥65 y + matched controls | 131/393 | 2–3 years | Directorate of Public Health, Catalonia | Low | Y/Nd |
| Leventer-Roberts, 2015 [29] | Case-control | Israel | IPD cases ≥65 y + matched controls | 212/848 | up to 5 years | Pfizer | Low | Y/Nd |
| Vila-Corcoles 2009 [28] | Case-control | Spain | IPD and PP cases ≥50 y (74% ≥65 y) + matched controls |
|
up to 7.5 years | Spanish Health Ministry | Low | Y/Y |
| Andrews 2012 [30] | Case-case | England & Wales | IPD cases ≥65 y | 444/369 e | up to 5 years | Health Protection Agency | Low | Y/Nd |
| Gutiérrez 2014 [33] | Case-case | Spain | IPD cases ≥60 y | 588/211 e | up to 5 years | No information | Low | Y/Nd |
| Rudnick 2013 [32] | Case-case | Canada | IPD cases ≥65 y | 1138/240 e | up to 5 years | Canadian Institutes for Health Research, CDC USA, Ontario Thoracic Society, Abbott Laboratories, Bayer Healthcare, GlaxoSmithKline, Pfizer | Low | Y/Nd |
| Wright 2013 [31] | Case-case | England | IPD cases ≥65 y | 374/73 e | up to 9 years | Health Protection Agency, Sanofi Pasteur MSD | Low | Y/Nd |
| Wiemken 2014 [35] | Case-case | USA, Europe | CAP cases ≥65 y | 279/2409 f | No information | No funding | High | N/Y |
CAP = community-acquired pneumonia, IPD = invasive pneumococcal disease, PP = pneumococcal pneumonia, PY = person years follow-up,
VT IPD = vaccine type invasive pneumococcal disease, Y = yes, N = no
a Endpoint PP excluded because the majority or all of the reported PP cases were diagnosed using insufficiently specific serologic tests for pneumolysin antibodies
b Pseudo randomization according to birth year (even/uneven)
c Endpoint PP not reported
d Only IPD cases were included in the study.
e IPD cases caused by vaccine serotypes / IPD cases caused by non-vaccine serotypes
f CAP cases caused by pneumococci / CAP cases of other or unknown etiology