Table 2 Patient characteristics
Lead author (year) | Country of conduct and year | Age category | Mean age (SD) in years | M/F, % | Sample size | |
|---|---|---|---|---|---|---|
Vaccine | Placebo | |||||
Leibovitz (1971) [24] | USA, 1970 | Adults | NR | NR | 1,682 | 7,934 |
Beutner (1979) [25] | USA, 1974 | Children | Range: 7 to 14 | 50/50 | 520 | 460 |
Rytel (1977) [26] | USA, 1974 | Adults | NR | 0/100 | 95 | 48 |
Monto (1982) [27] | USA, 1979 | Adults | NR | NR | 144 | 140 |
Tannock (1984) [28] | Australia, 1981 | Adults | 34.8 (13.9) | 69/31 | 19 | 20 |
Keitel (1997) [29] | USA, 1983 to 1988 | Adults | Range: 30 to 60 | NR | Y1: 161 | Y1: 298 |
Y2: 172 | Y2: 241 | |||||
Y3: 153 | Y3: 253 | |||||
Y4: 203 | Y4: 217 | |||||
Y5: 121 | Y5: 145 | |||||
Gruber (1990) [30] | USA, 1985 | Children | 7.9 (3.3) | NR | 54 | 77 |
Edwards (1994) [31] | USA, 1986 to 1990 | Adults/Children | Range: 1 to 65 | NR | LAIV/TIV | |
Y1: 872/878 | Y1: 878 | |||||
Y2: 1,029/1,060 | Y2: 1,064 | |||||
Y3: 1,114/1,126 | Y3: 1,125 | |||||
Y4: 999/1,016 | Y4: 1,016 | |||||
Clover (1991) [32] | USA, 1989 | Children | 8.8 (3.6) | NR | TIV/BIV 54/56 | 82 |
Govaert (1994) [33] | The Netherlands, 1991 | Older patients | Range: 60 to 91 | 47/53 | 927 | 911 |
Powers (1995) [34] | USA, 1993 | Adults | Range: 18 to 45 | NR | TIV/other 26/26 | 24 |
Belshe (1998) [35] | USA, 1996 | Children | 3.5 (1.4) | 47/53 | 1,070 | 532 |
Rudenko (2001) [36] | Russia, 1996 | Older patients | Median: 73, Range: 41 to 95 | 30/70 | LAIV/TIV 111/93 | 109 |
Belshe (2000) [37] | USA, 1997 | Children | 4.5 (1.4) | 52/48 | 917 | 441 |
Bridges (2000) [38] | USA, 1997 to 1999 | Adults | Median: 43.5 | 78/22 | Y1: 138 | Y1: 137 |
Y2: 141 | Y2: 137 | |||||
Hoberman (2003) [39] | USA, 1999 to 2001 | Children | Range: 0.5 to 2 | 56/44 | Y1: 273 | Y1: 138 |
Y2: 252 | Y2: 123 | |||||
Tam (2007) [40] | Multisite trial in Asia, 2000 to 2002 | Children | 1.9 (0.6) | 53/47 | Y1: 1,653 | Y1: 1,111 |
Y2: 503 | Y2: 494 | |||||
Vesikari (2006) [41] | Multisite trial in Europe and Israel, 2000 to 2001 | Children | 2.0 (0.7) | 51/49 | Y1: 951 | Y1: 665 |
Y2: 640 | Y2: 450 | |||||
Bracco Neto (2009)a[10] | Multisite trial in South Africa and South America, 2001 to 2002 | Children | Range: 0.5 to 3 | 49/51 | Y1: 944 | Y1: 942 |
Y2: 338 | Y2: 342 | |||||
Forrest (2008) [42] | Multisite in Asia, 2002 | Children | 1.8 Range: 0.5 to 3 | NR | 525 | 516 |
Lum (2010) [43] | Multisite trial in Asia, Europe and South America, 2002 | Children | 1.2 (0.3) | 50/50 | 765 | 385 |
Langley (2011) [44] | Canada, 2003 | Adults | 37.1 (12.2) | 46/54 | 455 | 443 |
Ohmit (2006)a[11] | USA, 2004 | Adult | 26.9 (9.3) | 38/62 | LAIV/TIV 519/522 | 206 |
Treanor (2007)a[12] | USA, 2004 | Adults | Median: 31, Range: 18 to 49 | 37/63 | 151 | 153 |
Beran (2009) [45] | Czech Republic, 2005 | Adults | 35 (13) | 45/55 | 4,137 | 2,066 |
Jackson (2010) [15] | USA, 2005 | Adults | 32.7 (9.1) | 40/60 | Y1: 1,706 | Y1: 1,725 |
Y2: 2,011 | Y2: 2,043 | |||||
Ohmit (2008)a[13] | USA, 2005 | Adults | 24.9 (NR) | 40/60 | LAIV/TIV 853/867 | 338 |
Beran (2009) [46] | Multisite trial Europe, 2006 | Adults | 40.0 (13.3) | 40/60 | 5,103 | 2,549 |
Monto (2009)a[14] | USA, 2007 | Adults | 23.3 (7.4) | 38/62 | LAIV/TIV 813/814 | 325 |
Frey (2010) [47] | Multisite trial North America and Europe, 2007 | Adults | 32.5 (NR) | 44/45 | LAIV/TIV 3,776/3,638 | 3,843 |
Range: 18 to 48 | ||||||
Treanor (2011) [48] | USA, 2007 | Adults | 32.5(NR) | 41/59 | 2,344 | 2,304 |
Range: 18 to 55 | ||||||
Barrett (2011) [49] | Multisite trial in USA, 2008 | Children | Range: 18 to 49 | NR | 3,619 | 3,617 |
Cowling (2010) [50] | Hong Kong, 2008 | Children | Range: 6 to 15 | 53/47 | 71 | 48 |
Talaat (2010) [51] | USA, 2009 | Adults and older patients | 56.5 (18.0) | 43/57 | 389 | 97 |