Pedroza 2009.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐arm trial for 56 days following first vaccination | |
Participants | Location: Mexico Number and age of participants: 163 (31 placebo, 132 influenza vaccine) children aged 5 to 9 years with mild intermittent and moderate persistent asthma Exclusion criteria: history of allergy to egg protein or thimerosal No details of past vaccination against influenza |
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Interventions | Vaccination type: intramuscular injection of trivalent inactivated influenza vaccine, 2 doses (28 days apart) Fluzone1 (Sanofi Pasteur) A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), B/Victoria/504/2000. Placebo: injection used |
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Outcomes | Primary outcome: adverse events (systemic and local) Secondary outcomes: pulmonary function tests (force expiratory volume in 1 second (FEV1) 5 days after each vaccination) and immunogenicity |
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Notes | Sponsored by Sanofi Pasteur | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Single blind, the contents of the syringe were shielded from the participants and administered by a clinician who was not involved in assessment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "All the data were recorded by research nurses and physicians who were not aware of the product administered to individuals in the study" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details of drop‐outs |