Protective Efficacy of Seasonal Influenza Vaccination against Seasonal and Pandemic Influenza Virus Infection during 2009 in Hong Kong

Cowling, Benjamin J.; Ng, Sophia; Edward, S. K.; Cheng, C.; Wai, Winnie; Fang, Vicky J.; Chan, Kwok‐Hung; Ip, Dennis K. M.; Chiu, Susan S.; Peiris, J. S. Malik; Leung, Gabriel M.

doi:10.1086/657311

Cited by 146 publications

(180 citation statements)

References 58 publications

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“…Of the 4,372 studies initially identified (Figure), 18 RCTs [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39], 14 non-randomised clinical trials [40][41][42][43][44][45][46][47][48][49][50][51][52][53], and six observational studies [54][55][56][57][58][59] were eligible for inclusion. The clinical trial registry search yielded 12 additional relevant studies (five RCTs and seven nonrandomised trials).…”

Section: Resultsmentioning

confidence: 99%

“…Multiple study designs were encountered in terms of comparison groups; for non-adjuvanted TIV, comparison with placebo was only found in one study [33]. Five studies examined adjuvanted vaccines (MF59 or virosomal adjuvant) in at least one study arm [30,31,34,35,39].…”

Section: Characteristics Of Randomised Controlled Trialsmentioning

confidence: 99%

“…Five studies were assessed as being at low risk of bias [26,31,[33][34][35]. Ten studies had medium risk of bias [22,24,25,[27][28][29][30]32,38,39], and three studies had high risk [23,36,37].…”

Section: Characteristics Of Randomised Controlled Trialsmentioning

confidence: 99%

“…RCTs using Sanofi Pasteur products (Vaxigrip, Fluzone) [22][23][24][25][26]29,[31][32][33]36,38], GSK's Fluarix [27,32,37], and Novartis's Agrippal [28] were examined (Table 3). Overall, fever rates were comparable between these brands of vaccine.…”

Section: Randomised Studiesmentioning

confidence: 99%

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Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

et al. 2015

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In 2010, increased febrile convulsions (FC) occurred after administration of inactivated trivalent influenza vaccine (TIV) in Australia. We systematically reviewed the rates of fever, FC and serious adverse events (SAEs) after TIV, focussing on published and unpublished clinical trial data from 2005 to 2012, and performed meta-analysis of fever rates. From 4,372 records in electronic databases, 18 randomised controlled trials (RCTs), 14 non-randomised clinical trials, six observational studies and 12 registered trials (five RCTs and seven non-randomised) were identified. In published RCTs, fever ≥ 38 °C rates after first dose of non-adjuvanted TIV were 6.7% and 6.9% for children aged 6-35 months and ≥ 3 years, respectively. Analysis of RCTs by vaccine manufacturer showed pooled fever estimates up to 5.1% with Sanofi or GlaxoSmithKline vaccines; bioCSL vaccines were used in two non-randomised clinical trials and one unpublished RCT and were associated with fever in 22.5-37.1% for children aged 6-35 months. In RCTs, FCs occurred at a rate of 1.1 per 1,000 vaccinated children. While most TIVs induced acceptably low fever rates, bioCSL influenza vaccines were associated with much higher rates of fever in young children. Future standardised study methodology and access to individual level data would be illuminating.

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Section: Resultsmentioning

confidence: 99%

Section: Characteristics Of Randomised Controlled Trialsmentioning

confidence: 99%

Section: Characteristics Of Randomised Controlled Trialsmentioning

confidence: 99%

Section: Randomised Studiesmentioning

confidence: 99%

See 2 more Smart Citations

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

et al. 2015

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“…Seasonal influenza vaccination provided 20–77% in children depending on antigenic match, against laboratory‐confirmed influenza (Table 2). 18, 47, 48, 49, 50, 51, 52, 53, 54, 55 Vaccinating school children provided 23·3% (66·3–74·9) protection against influenza and indirect protection of 61% (5·8–84·7) for household contacts 56. Vaccinating pregnant women prevented laboratory‐confirmed influenza in both mothers (50%) and their infants up to 6 months of age (49–63%) 57, 58.…”

Section: Resultsmentioning

confidence: 99%

Seasonal influenza vaccine policy, use and effectiveness in the tropics and subtropics – a systematic literature review

Hirve

Lambach

Paget

et al. 2016

Influenza Resp Viruses

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AimThe evidence needed for tropical countries to take informed decisions on influenza vaccination is scarce. This article reviews policy, availability, use and effectiveness of seasonal influenza vaccine in tropical and subtropical countries.MethodGlobal health databases were searched in three thematic areas – policy, availability and protective benefits in the context of human seasonal influenza vaccine in the tropics and subtropics. We excluded studies on monovalent pandemic influenza vaccine, vaccine safety, immunogenicity and uptake, and disease burden.ResultsSeventy‐four countries in the tropics and subtropics representing 60% of the world's population did not have a national vaccination policy against seasonal influenza. Thirty‐eight countries used the Northern Hemisphere and 21 countries the Southern Hemisphere formulation. Forty‐six countries targeted children and 57 targeted the elderly; though, the age cut‐offs varied. Influenza vaccine supply increased twofold in recent years. However, coverage remained lower than five per 1000 population. Vaccine protection against laboratory‐confirmed influenza in the tropics ranged from 0% to 42% in the elderly, 20–77% in children and 50–59% in healthy adults. Vaccinating pregnant women against seasonal influenza prevented laboratory‐confirmed influenza in both mothers (50%) and their infants <6 months (49–63%).ConclusionGuidelines on vaccine composition, priority risk groups and vaccine availability varied widely. The evidence on vaccine protection was scarce. Countries in the tropics and subtropics need to strengthen and expand their evidence‐base required for making informed decisions on influenza vaccine introduction and expansion, and how much benefit to expect.

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Estimation of intervention effect using paired interval‐censored data with clumping below lower detection limit

Lam

Cowling

et al. 2014

Statistics in Medicine

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Outcome variables that are semicontinuous with clumping at zero are commonly seen in biomedical research. In addition, the outcome measurement is sometimes subject to interval censoring and a lower detection limit (LDL). This gives rise to interval-censored observations with clumping below the LDL. Level of antibody against influenza virus measured by the hemagglutination inhibition assay is an example. The interval censoring is due to the assay's technical procedure. The clumping below LDL is likely a result of the lack of prior exposure in some individuals such that they either have zero level of antibodies or do not have detectable level of antibodies. Given a pair of such measurements from the same subject at two time points, a binary 'fold-increase' endpoint can be defined according to the ratio of these two measurements, as it often is in vaccine clinical trials. The intervention effect or vaccine immunogenicity can be assessed by comparing the binary endpoint between groups of subjects given different vaccines or placebos. We introduce a two-part random effects model for modeling the paired interval-censored data with clumping below the LDL. Based on the estimated model parameters, we propose to use Monte Carlo approximation for estimation of the 'fold-increase' endpoint and the intervention effect. Bootstrapping is used for variance estimation. The performance of the proposed method is demonstrated by simulation. We analyze antibody data from an influenza vaccine trial for illustration.

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Protective Efficacy of Seasonal Influenza Vaccination against Seasonal and Pandemic Influenza Virus Infection during 2009 in Hong Kong

Abstract: ClinicalTrials.gov number NCT00792051 .

Cited by 146 publications

References 58 publications

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

Systematic review of fever, febrile convulsions and serious adverse events following administration of inactivated trivalent influenza vaccines in children

Seasonal influenza vaccine policy, use and effectiveness in the tropics and subtropics – a systematic literature review

Estimation of intervention effect using paired interval‐censored data with clumping below lower detection limit

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