ab Langley 2005.
Methods | Randomised controlled trial | |
Participants | Healthy adults aged 18 to 50 years | |
Interventions | Inactivated A/New Caledonia/20/99 (H1N1) + A/Panama/2007/99 (H3N2) + B/Guangdong/120/2000 non‐covalent associated with outer membrane protein of Neisseria meningitidis. Single nasal dose containing 15, 30, 45 µg versus placebo (phosphate‐buffered saline) intranasally administered. | |
Outcomes | Local: within 7 days, graphic: rhinorrhoea, congestion, itch/burn, nosebleed, red/puffy eyes, sneezing, sore throat. Systemic: within 7 days: cough, shortness of breath, headache, muscle/joint aches, poor appetite, fatigue within 48 hours, nasal mucosa inflammation, nasal discharge, pharyngeal inflammation, sinusitis, enlarged cervical/postauricular nodes. | |
Notes | Safety data only were extracted. Government and industry funded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear |
Allocation concealment (selection bias) | High risk | Inadequate |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
Summary assessment | High risk | High risk |