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. 2011 Oct 21;37(ACS-6):1–68. doi: 10.14745/ccdr.v37i00a06

Table 8. Summary of Evidence for NACI Recommendation(s).

Evidence related to effectiveness of Fluad® vaccine in adults 61 years of age and older
Study Vaccine Study Design Participants Summary of Key Findings Using Text or Data Level of Evidence Quality
Iob et al. Evidence of increased clinical protection of an MF59®-adjuvant influenza vaccine compared to a non-adjuvant vaccine among elderly residents of long-term care facilities in Italy. Epidemiol Infect. 2005;133 (4):687-93 (4). Fluad® (MF59®-adjuvanted subunit influenza vaccine) vs. Agrippal S1® (non-adjuvanted subunit influenza vaccine)
IM; 15µg of each of the A/Sydney/5/97(H3N2); A/Beijing/262/95(H1N1); B/Beijing/184/93 strains		 Uncontrolled observational multi-center study
Italy		 3173 residents from 25 long-term care facilities (mean age 85 ± 10 years); 3.65% persons <65 years
Categorized as having no underlying disease, heart disease alone, respiratory disease alone, renal disease alone, or having more than one of these diseases		 Incidence of influenza-like illness; stratified based on respiratory, cardiovascular and renal disease.
Vaccination effectiveness: Overall (vaccine vs. no vaccine): OR 2.16, 95% CI 1.56-2.98)
Fluad®: 94% (47-100%)
Agrippal S1®: 24.5% (0-45%)
Influenza-like illness:

  • • Agrippal S1® vs. Fluad®

  • • Facilities reporting ILI and underlying chronic disease: OR 1.52 (95% CI 1.22-1.88)

  • • Above + facilities reporting no ILI: OR 1.72 (95% CI 1.39-2.12)

  • • Above + facilities missing information on chronic diseases: OR 1.80 (95% CI 1.47-2.21)

  • • Underlying respiratory disease: OR 2.27, 95% CI 1.09-4.82)

  • • Underlying heart disease: OR 1.88 95% CI 1.31-2.72)

MF59-adjuvanted vaccine (Fluad®) provided better protection for elderly subjects, especially those
with comorbidities in having influenza-like illness		 • II-2 Poor
(risk of bias; reason for choosing product by long term care facility unknown; frequency of risk factors for complications in each vaccine group unknown; impact of outbreaks not discussed)
Mannino et al. Effectiveness of influenza vaccination with Fluad® versus a subunit influenza vaccine. Canadian Geriatrics Society 31st Annual Scientific Meeting; Vancouver; 2011 (7). Fluad® (MF59-adjuvanted subunit influenza vaccine) vs. Agrippal® (non-adjuvanted subunit influenza vaccine) Cohort study; multi-season (may have looked at the same patients for more than one season) 164,007 person-seasons, subjects ≥65 years with or without comorbidities Hospitalization
Fluad® group had more underlying comorbidities and a higher risk of hospitalizations outside of influenza season vs. Agrippal® group (RR 1.19; 95% CI 0.98-1.45)
A significantly lower risk of hospitalization during influenza season (RR 0.77; 95% CI 0.59-0.99) in population receiving Fluad® vs. Agrippal® A significantly lower risk of hospitalization for all respiratory disease during influenza season (RR 0.79; 95% CI 0.66-0.95) in population receiving Fluad® vs. Agrippal®
During influenza season, vaccination with Fluad® reduced hospitalizations for influenza and pneumonia by 23% compared with Agrippal®.		 II-2 Poor
(Personal communication)
Puig-Barbera et al. Effectiveness of MF59-adjuvanted subunit influenza vaccine in preventing hospitalisations for cardiovascular disease, cerebrovascular disease and pneumonia in the elderly. Vaccine. 2007;25(42):7313-21. (5) Fluad® (MF59-adjuvanted subunit influenza vaccine) vs. No vaccination 3 case-control studies; multicenter
November 2004 to March 2005		 Subjects >64 years; Cases n=134-198; Controls n=246-321
Cases: Consecutive non-institutionalized elderly living in hospital catchment area for previous 6 months, and admitted for emergency hospitalization between Nov 2004 and Mar 2005 acute coronary syndrome (ACS), cerebrovascular accidents (CVA) or pneumonia
Controls: Hospital and gender matched with same inclusion criteria as cases for acute surgical process or trauma within 0-10 days of case admission date		 Risk of hospitalization for ACS, CVA or pneumonia
Hospitalization for Fluad® vs. no vaccination
ACS - greater reduction in risk observed after peak of influenza circulation

  • • OR: 0.89; 95% CI 0.37-2.08

  • • Adjusted OR: 0.13; 95% CI 0.03-0.65

CVA – greater reduction in risk during peak of influenza circulation

  • • OR: 0.66; 95% CI 0.31-1.40

  • • Adjusted OR 0.07; 95% CI 0.01-0.48)

Pneumonia – greater reduction in risk during peak influenza circulation

  • • OR: 0.73; 95% CI

  •    0.40-1.35

  • • Adjusted OR 0.31; 95% CI 0.14-0.71

Adjusted OR accounted for likelihood of vaccination and relevant confounding factors (e.g. underlying chronic disease, use of therapeutics, caregiver vaccination, smoking, etc.)
Vaccine effectiveness (Risk reduction)
ACS: 87%; 95% CI 35-97
CVA: 93%; 95% CI 52-99
Pneumonia: 69%; 95% CI 29-86		 II-2 Fair
Thorough methodology with identification of potential confounding factors and controlling potential bias using propensity score
Puig-Barbera et al. Effectiveness of the MF59-adjuvanted influenza vaccine in preventing emergency admissions for pneumonia in the elderly over 64 years of age. Vaccine. 2004;23 (3):283-9 (6). Fluad® (MF59-adjuvanted subunit influenza vaccine) vs. No vaccination Case-control study; multicenter
November 2002 to March 2003		 Subjects ≥65 years; Cases n=290; Controls n=525
Cases: Non-institutionalized elderly living in hospital catchment area for previous 6 months, and admitted for emergency hospitalization between Nov 2002 and Mar 2003 with confirmed pneumonia
Controls: Hospital and gender matched with same inclusion criteria as cases for surgical or traumatological acute condition within 0-7 days of case admission date		 Risk of hospitalization (emergency admission) for pneumonia
Fluad® vs. no vaccination Preventing emergency admission for pneumonia: Adjusted effectiveness of 48%; 95% CI 20-66%
Adjusted for heart disease, COPD, asthma, Barthel index score <60, smoking, administered pneumococcal vaccine, attending out patient clinics		 II-2 Fair