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 |
aUnpublished data was obtained from the author(s).
LAIV live attenuated influenza vaccine, NR not reported, TIV trivalent inactivated vaccine.