Summary
Objective
Methods
Results
Conclusions
Keywords
Introduction
Methods
Identification of evidence
Study selection
Trial and reference details | Population characteristics | Interventions (no. of patients in each arm) | Preventative strategy | Prophylaxis duration |
---|---|---|---|---|
WV15825; Peters et al., 2001 61 De Bock et al., 200082 | At-risk elderly subjects living in a residential home (Mean age = 81–82 yrs across treatment arms age 81 yr) (98% with concomitant disease in each group), Intervention arm: 80.4% vaccinated Placebo arm: 80.1% vaccinated | Intervention arm: Oseltamivir 75 mg once daily n = 276 Placebo arm: n = 272 | Seasonal | 6 weeks |
WV15673; Hayden et al., 1999 62 | Healthy unvaccinated adults aged 18–65 yrs living in the community. Conducted at study sites in Virginia, USA | Intervention arm: Oseltamivir 75 mg once daily n = 268 Placebo arm: n = 268 | Seasonal | 6 weeks |
WV15697; Hayden et al., 1999 62 | Healthy unvaccinated adults aged 18–65 yrs living in the community. Conducted at study sites in Texas and Kansas City, USA | Intervention arm: Oseltamivir 75 mg once daily n = 252 Placebo arm: n = 251 | Seasonal | 6 weeks |
WV15799; Welliver et al., 2001 59 | Subjects of mixed age and health status living in households. Adults and children aged 12 years and above (as contacts),Contacts of all index cases: Intervention arm: 11.4% vaccinated. Placebo arm: 13.9% vaccinated Index cases did not receive treatment. | Intervention arm: Oseltamivir 75 mg once daily n = 493 Placebo arm: n = 462 | Post-exposure prophylaxis | 7 days |
WV16193; Hayden et al., 2004 60 ;Hayden et al., 2002 83 ; Belshe et al., 200184 | Subjects of mixed age and health status. Adults and children aged 1 year and above. Contacts: Oseltamivir prophylaxis arm: 8% vaccinated Expectant treatment arm: 7% vaccinated Index cases in both arms received treatment with oseltamivir 75 mg twice daily for 5 days. | Oseltamivir: prophylaxis (PEP) vs. treatment on influenza onset (expectant treatment); index cases in both groups received treatment. Oseltamivir prophylaxis arm: Oseltamivir 75 mg daily for 10 days, n = 410 Expectant treatment arm: Oseltamivir treatment on influenza onset 75 mg twice daily for 5 days (less in children), n = 402 Subjects reported as ≤ 12 years Oseltamivir prophylaxis arm: n = 69, Expectant treatment arm: n = 65 | Post-exposure prophylaxis | 10 days |
Trial and reference details | Population characteristics | Interventions (no. of patients in each arm) | Preventative strategy | Prophylaxis duration |
---|---|---|---|---|
NAIA3005; Monto et al., 1999 72 | Healthy adults (aged 18–64 years) from University communities, Intervention arm: 14% vaccinated Placebo arm: 14% vaccinated | Intervention arm: Zanamivir 10 mg once daily n = 553 Placebo arm: n = 554 | Seasonal | 28 days |
NAI30034; LaForce et al., 2007 73
Efficacy and safety of inhaled zanamivir in the prevention of influenza in community-dwelling, high-risk adult and adolescent subjects: a 28-day, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2007; 29: 1579-1590 | At-risk adolescents and adults (aged 12 yrs and above). High-risk defined as age 65 yrs and above or having chronic disorders of pulmonary or cardiovascular system or diabetes mellitus. Intervention arm: 67% vaccinated Placebo arm: 68% vaccinated | Intervention arm: Zanamivir 10 mg once daily n = 1678 randomised, n = 1595 completed study Placebo arm: n = 1685 randomised, n = 1594 completed study Aged ≥65 years n = 946 | Seasonal | 28 days |
NAI30031; Monto et al., 2002 63 | Subjects of mixed age and health status. Adults and children aged 5 years and above (as contacts). Index cases: Intervention arm: 8% vaccinated, Placebo arm: 5% vaccinated, Contact cases: Intervention arm: 11% vaccinated, Placebo arm: 10% vaccinated Index cases did not receive treatment. | Intervention arm: Zanamivir 10 mg once daily n = 661 Placebo arm: n = 630 | Post-exposure prophylaxis | 10 days |
NAI30010; Hayden et al., 2000 64 | Subjects of mixed age and health status. Adults and children aged 5 years and above. Contacts: Intervention arm: 14% vaccinated, Placebo arm: 18% vaccinated Index cases were randomised to zanamivir twice daily or placebo. | Intervention arm: Zanamivir inhaled 10 mg daily n = 414 Placebo arm: n = 423 | Post-exposure prophylaxis | 10 days |
NAIA2009, NAIB2009; Kaiser et al., 2000 65 | Subjects of mixed age and health status. Unvaccinated adults and children aged 13–65 years (as contacts). Index cases did not receive treatment. | Intervention arm: Zanamivir 10 mg inhaled daily n = 144 Placebo arm: n = 144 | Post-exposure prophylaxis | 5 days |
NAIA3004; Ambrozaitis et al., 2005 66 ;Ambrozaitis et al., 2001 85 | At-risk elderly subjects in long-term care (mean age Intervention arm = 66.8 yrs, Placebo arm = 67.2 yrs) (84–85% at-risk of complications) Intervention arm: 9.6% vaccinated, Placebo arm: 8.8% vaccinated | Intervention arm: Zanamivir once daily n = 242 Placebo arm: n = 252 | Outbreak control | 14 days |
NAIA3003; Gravenstein et al., 2005 74 | At-risk elderly subjects in long-term care (mean age Intervention arm = 76.3 yrs, Placebo arm = 74.8 yrs) (96–100% at-risk of complications) Intervention arm: 99% vaccinated, Placebo arm: 92% vaccinated | Intervention arm: Zanamivir 10 mg once daily n = 12 for influenza B outbreak Placebo arm: Placebo n = 13 for influenza B outbreak | Outbreak control | 14 days |
Trial and reference details | Population characteristics | Interventions (no. of patients in each arm) | Preventative strategy | Prophylaxis duration |
---|---|---|---|---|
Reuman et al., 1989 70 | Healthy unvaccinated adults aged 18–55 years living in the community | Intervention arm: Amantadine 100 mg/day n = 159 Placebo arm: n = 159 | Seasonal | Presumed 6 weeks |
Aoki et al., 1986 71 | Healthy adults in a military setting, (age not defined) 6–8 individuals in each study year immunised against influenza in previous years | Intervention arm: Amantadine 100 mg/day, 1980–1981 n = 74, 1981–1982: under 28 yrs n = 21, over 29 yrs n = 29, 1982–1983 n = 46 Placebo arm: 1980–1981 n = 48, 1981–1982: under 28 yrs n = 16, over 29 yrs n = 18, 1982–1983 n = 33 | Seasonal | 39 days (1980–1981) 32 days (1982–1983) |
Pettersson et al., 1980 75 | Elderly subjects (mean ages Intervention arm = 77.4 yrs, Placebo arm = 79.0 yrs) living in a residential home, vaccination status unclear, but discussion states no adequate vaccine available | Intervention arm: Amantadine 100 mg/day, randomised n = 94, completing study n = 89 Placebo arm: randomised n = 101, completing study n = 99 | Seasonal | 9 weeks |
Payler & Purdham, 1984 67 | Adolescent males (13–19 yrs old) in boarding school setting, 87% vaccinated | Intervention arm: Amantadine 100 mg/day randomised n = 299, final analysis n = 267 Comparison arm: No specific treatment randomised n = 307, final analysis n = 269 | Outbreak control | 14 days |
Smorodintsev et al., 1970a, b 68 , 69 | Male adults (recruitment pool aged 18–30 yrs) (presumed healthy) in semi-isolated engineering school populations | Intervention arm: Amantadine 100 mg/day (50.7% of 10,053), assigned to group n = 5092, onset of influenza prior to dosing n = 441, n = 4559 regularly or irregularly taking amantadine. Placebo arm: (31.6% of 10,053), assigned to group n = 3175, onset of influenza prior to dosing n = 307, n = 2804 receiving placebo (3175 minus 307 = 2868, 2804 included in analysis. Internal control arm: individuals at the same engineering schools as the amantadine and placebo groups, but living at home rather than at the school; received no prophylaxis (10.0% of 10,053) n = 1011 External control: individuals at an 8th engineering school; received no prophylaxis (7.7% of 10,053), assigned to group n = 775 | Outbreak control | 5 of 7 populations dosed for 30 days, 2 populations dosed for 12 days |
Data abstraction
Quality assessment
Data synthesis
Results
Prevention of symptomatic, laboratory-confirmed influenza
Prophylactic strategy | Relative risk of developing symptomatic, laboratory-confirmed influenza (95%C.I.) | ||
---|---|---|---|
Amantadine | Oseltamivir | Zanamivir | |
Seasonal prophylaxis in healthy children | Dosage not established in children | NDA | NDA |
Seasonal prophylaxis in at-risk children | Dosage not established in children | NDA | NDA |
Seasonal prophylaxis in healthy adults | 0.40 (0.08–2.03) (Reuman et al., 1989) 70 From 1 trial | 0.24 (0.09–0.54) (Hayden et al., 1999) 62 From 2 trials | 0.32 (calculated by assessment group) (0.17–0.63) (Monto et al., 1999) 72 From 1 trial |
Seasonal prophylaxis in at-risk adults and adolescents | NDA | NDA | 0.17 (0.07–0.44) (LaForce et al., 2007) 73
Efficacy and safety of inhaled zanamivir in the prevention of influenza in community-dwelling, high-risk adult and adolescent subjects: a 28-day, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2007; 29: 1579-1590 From 1 trial |
Seasonal prophylaxis in healthy elderly subjects | No data reported (Pettersson et al., 1980) 75 | NDA | 0.20 (0.02–1.72) (LaForce et al., 2007) 73
Efficacy and safety of inhaled zanamivir in the prevention of influenza in community-dwelling, high-risk adult and adolescent subjects: a 28-day, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2007; 29: 1579-1590 From 1 trial |
Seasonal prophylaxis in at-risk elderly subjects | No data reported (Pettersson et al., 1980) 75 | 0.08 (0.01–0.63) (Peters et al., 2001) 61 (98% subjects with concomitant disease) From 1 trial | 0.20 (0.02–1.72) (LaForce et al., 2007) 73
Efficacy and safety of inhaled zanamivir in the prevention of influenza in community-dwelling, high-risk adult and adolescent subjects: a 28-day, multicenter, randomized, double-blind, placebo-controlled trial. Clin Ther. 2007; 29: 1579-1590 From 1 trial |
Prophylactic strategy | Relative risk of developing symptomatic, laboratory-confirmed influenza (95%C.I.) | ||
---|---|---|---|
Amantadine | Oseltamivir | Zanamivir | |
Post-exposure prophylaxis in mixed households | NDA | 0.19 (0.08–0.45) (Hayden et al., 2004) 60 ; Welliver et al., 2001)59 From 2 trials | 0.21 (0.13–0.33) (Hayden et al., 2000; 64 Kaiser et al., 2000;65 Monto et al., 2002)63 From 4 trials |
Post-exposure prophylaxis in healthy children | Dosage not established in children | 0.36 (0.15–0.84) (Hayden et al., 2004) 60 From 1 trial | NDA |
Post-exposure prophylaxis in at-risk children | Dosage not established in children | NDA (subjects with a number of chronic conditions excluded) (Hayden et al., 2004) 60 | NDA |
Post-exposure prophylaxis in healthy adults and adolescents | 0.10 (0.03–0.34) (Payler & Purdham, 1984) 67 From 1 trial | NDA | NDA |
Post-exposure prophylaxis in at-risk adults and adolescents | NDA | NDA | NDA |
Post-exposure prophylaxis in healthy elderly subjects | NDA | NDA | NDA |
Post-exposure prophylaxis in at-risk elderly subjects | NDA | NDA | 0.68 (0.33–1.27) (Ambrozaitis et al., 2005) 66 (calculated by assessment group)(Subjects 85% at-risk of complications) |
Use of oseltamivir in seasonal prophylaxis
Use of oseltamivir in post-exposure prophylaxis
Use of zanamivir in seasonal prophylaxis
- LaForce C.
- Man C.Y.
- Henderson F.W.
- McElhaney J.E.
- Hampel Jr., F.C.
- Bettis R.
- et al.
Use of zanamivir in post-exposure prophylaxis
Use of amantadine in seasonal prophylaxis
Use of amantadine in post-exposure prophylaxis
Secondary outcomes
Use of oseltamivir in seasonal prophylaxis
Use of oseltamivir in post-exposure prophylaxis
Use of zanamivir in seasonal prophylaxis
Use of zanamivir in post-exposure prophylaxis
Use of amantadine in seasonal prophylaxis
Use of amantadine in post-exposure prophylaxis
Adverse events
Vaccination status
- LaForce C.
- Man C.Y.
- Henderson F.W.
- McElhaney J.E.
- Hampel Jr., F.C.
- Bettis R.
- et al.
Antiviral resistance
Discussion
Strengths and limitations of review
Comparison with related literature
Implications for practice
Areas for future research
Role of the funding source
Acknowledgements
References
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