Table 3. Post-vaccination GMTs and seroprotection rates of Fluad®, non-adjuvanted subunit vaccines and split vaccines against homologous and heterologous strains for adults 61 years of age and older.
| Study (Health status) | Comparator (Season) | Post-vaccination GMT and [Seroprotection rate, %] (Fluad® vs. comparator) | ||
|---|---|---|---|---|
| A/H3N2 | A/H1N1 | B | ||
| Fluad® and split vaccines | ||||
| Baldo et al. 2006 (15) (With and without comorbidities) | Mutagrip® (2004-2005) | 60.3 vs. 43.5, p<0.05 [90 vs. 65, p<0.005] |
104.7 vs. 120.2, NS [98.8 vs. 98.8, NS] |
51.5 vs. 40.2, p<0.05 [88 vs. 74, p<0.005] |
| Baldo et al. 2001 (16) (With and without comorbidities) | Mutagrip® (1998-1999) | 48.6 vs. 47.0 [79.8 vs. 80.6, NS] |
157.8 vs. 123.3 [100 vs. 100, NS] |
75.6 vs. 65.6 [98 vs. 100, NS] |
| Baldo et al. 2010 (14) (With comorbidities) | Mutagrip® (1998-1999) retesting sera of elderly with comorbidities, who participated in the trial of Baldo et al. 200117 |
Fluad® had higher GMT against 2006/2007 heterologous strain (p<0.01) [77.8 vs. 79.5, NS] | Fluad® had higher GMT against 2006/2007 heterologous strain (p<0.01) [100 vs. 98.9, NS] | Both vaccines had similar GMT against 2006/2007 heterologous strain (NS) [100 vs. 97.7, NS] |
| Del Giudice et al. 2006 (29) (With and without comorbidities) |
Begrivac® (2003-2004) |
Fluad® had higher GMT against 2004/2005 heterologous strain (p=0.006) [98.3 vs. 96.7, NS] | Not determined | Not determined |
| Menegon et al. 1999 (30) (with and without comorbidities) | Mutagrip® (1997-1998) | 221.4 vs. 153.4, <0.05 [NS difference; numerical data not reported] |
346.5 vs. 227.9, p<0.005 [NS difference; numerical data not reported] |
54.5 vs. 49.0, NS [Fluad® > Mutagrip, p<0.05) |
| Ruf et al. 2004 (24) (With and without comorbidities) | Fluarix® (2002-2003) |
Fluad® had lower GMT (p<0.0001) [88.4 vs. 90.1, overlap 95% CI] |
Fluad® had lower GMT (p<0.0001) [89.8 vs. 93.8, overlap 95% CI] |
Fluad® had higher GMT (NS) [94.9 vs. 91.2, overlap 95% CI] |
| Squarcione et al. 2003 (26) (Healthy) |
Vaxigrip® (1998-1999) |
214.3 vs. 183.2 [94.0 vs. 90.4, NS] |
154.4 vs. 87.1 [83.4 vs. 71.6, p not reported] |
24.0 vs. 18.9 [38.0 vs. 29.5, p not reported] |
| Van Damme et al. 2010 (27) (Healthy) |
Intanza™ (2007-2008) |
332.8 vs. 266.5 GMR: 1.25 (non-inferiority was demonstrated; upper bound of 95% CI was <1.5) [similar; numerical data not reported] |
121.6 vs. 108.8 GMR: 1.12 (non-inferiority was demonstrated; upper bound of 95% CI was <1.5) [similar; numerical data not reported] |
38.9 vs. 37.9 GMR: 1.03 (non-inferiority was demonstrated; upper bound of 95% CI was <1.5) [similar; numerical data not reported] |
| Fluad® and non-adjuvanted subunit vaccines | ||||
| De Donato et al. 1999 (18) (Healthy) |
Agrippal® (1993-1994) |
331 vs. 162, p<0.001 [83 vs. 68, p<0.001] |
252 vs. 177, p<0.001 [88 vs. 80, NS] |
137 vs. 84, p<0.001 [71 vs. 43, p<0.001] |
| Gasparini et al. 2001 (19) (Healthy) |
Agrippal® (1994-1995) |
103 vs. 55, p≤0.001 [51 vs. 34, p≤0.001] |
191 vs. 167, NS [88 vs. 85, NS] |
102 vs. 70, p≤0.001 [54 vs. 35, p≤0.001] |
| Li et al. 2008 (21) (Healthy) |
Agrippal® (2005-2006) |
274.61 vs. 110.85, p<0.001 [88 vs. 72, p<0.001] |
1439.01 vs. 1197.39, p=0.034 [99.7 vs. 99.5, NS] |
16.59 vs. 11.95, p=0.0005 [35.7 vs. 28.3, NS] |
| Minutello et al. 1999 (22) (Healthy) |
Agrippal® (1992/1993) |
189 vs. 149, NS Fluad® had higher GMT against 1993/1994 heterologous strains (by 75%) [83 vs. 61, NS] |
45 vs. 31, NS Fluad® had higher GMT against 1993/1994 strain* (103%) [22 vs. 17, NS] |
115 vs. 74, p≤0.005 Fluad® had higher GMT against 1993/1994 strain* (by 90%) [63 vs. 41, p≤0.05] |
| Ansaldi et al. 2010 (12) (Healthy) |
Agrippal® (2005-2006) |
Fluad® had higher GMT against 2004/2005 and 2006/2007 heterologous strains (p<0.05) [Both vaccines met EMA criteria] |
Not determined | Not determined |
| Ansaldi et al. 2008 (13) Healthy) |
Agrippal® 2004-2005) |
Fluad® had higher GMT against 2005/2006 and 2007/2008 heterologous strains (p<0.05) [Both vaccines met EMA criteria] |
Not determined | Not determined |
| Del Giudice et al. 2006 (29) (With and without comorbidities) |
Agrippal® (2003/2004) |
Fluad® had higher GMT against 2004/2005 heterologous strains (p=0.006) [98.3 vs. 75.9, p=0.0001] for heterologous strains |
Not determined | Not determined |
| Giammanco et al. 2005 (20) (Chronic obstructive pulmonary disease) |
Agrippal® (2003-2004) |
NS difference [NS difference] |
NS difference [NS difference] |
NS difference [NS difference] |
| Sindoni et al. 2009 (25) (With and without comorbidities) |
Agrippal® (2002-2003) |
378 vs. 257, p<0.05 [98.9 vs. 98.9, NS] |
256 vs. 185, p<0.05 [95.8 vs. 96, NS] |
160 vs. 170, NS [96.6 vs. 98, NS] |
| de Bruijn et al. 2007 (17) (With and without comorbidities) |
Influvac® (2004-2005) |
740 vs. 595, NS [100 vs. 99.2, NS] |
109 vs. 136, NS [84.1 vs. 88.8, NS] |
195 vs. 188, NS [94.4 vs. 89.6, NS] |