aa Cowling 2012.
| Methods | Cluster‐randomised, placebo‐controlled trial conducted in Hong Kong between 2009 and 2010 | |
| Participants | 796 children aged 6 to 17 in households | |
| Interventions | TIV (0.5 mL of Vaxigrip; Sanofi Pasteur) or placebo (0.5 mL of saline solution) intramuscularly. The 2009–10 TIV used included the strains A/Brisbane/59/2007(H1N1)‐like, A/Brisbane/10/ 2007(H3N2)‐like, and B/Brisbane/60/2008‐like. | |
| Outcomes | Influenza cases laboratory confirmed by viral culture and/or real‐time reverse transcription PCR or 4 fold in antibody titre. Mild, moderate, or severe adverse events recorded by parents for 4 days after vaccination. | |
| Funding Source | Hong Kong Government | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Groups of children allocated to vaccine or control group |
| Allocation concealment (selection bias) | Low risk | Computer‐generated random numbers |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Numbered, identical‐looking syringes |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Failure to report numerator numbers |
| Summary assessments | Low risk | |
ACIP: Advisory Committee on Immunization Practices AE: adverse event AOM: acute otitis media ARI: acute respiratory infection CAIV‐T: cold‐adapted influenza vaccine, trivalent CCA: chick cell‐agglutinating CCT: comparative controlled trial CI: confidence interval C‐RCT: cluster‐randomised controlled trial ED: emergency department EID: egg infective dose ELISA: enzyme‐linked immunosorbent assay EU: European Union EVM: Effective Vaccine Management FV: fully vaccinated HA: haemagglutinin HAI: haemagglutination antibody inhibition HI: haemagglutination‐inhibition HIPAA: Health Insurance Portability and Accountability Act of 1996 HMO: health maintenance organisation HPMG: HealthPartners Medical Group HR: hazard ratio ICD: International Classification of Diseases IgA: immunoglobulin A IgE: immunoglobulin E IgM: immunoglobulin M ILI: influenza‐like illness ITT: intention‐to‐treat IU: international unit LAIV: live attenuated influenza vaccine LRTI: lower respiratory tract infection N/A: not applicable NA: neuraminidase OM: otitis media OME: otitis media with effusion OR: odds ratio PCR: polymerase chain reaction P&I: pneumonia & influenza PIV: parainfluenza virus PV: partially vaccinated RCT: randomised controlled trial REM: rapid eye movement RSV: respiratory syncytial virus RT‐PCR: reverse transcription polymerase chain reaction SAE: serious adverse event SD: standard deviation TCID: tissue culture infective dose TIV: trivalent influenza vaccine TM: tympanic membrane URTI: upper respiratory tract infection UV: unvaccinated VE: vaccine efficacy/effectiveness VSD: Vaccine Safety Datalink WHO: World Health Organization