CFDB - Cystic Fibrosis DataBase

primary studies published, non RCT

Adverse events following live-attenuated intranasal influenza vaccination of children with cystic fibrosis: Results from two influenza seasons.

Study design (if review, criteria of inclusion for studies)

Prospective study

Participants

198 patients with cystic fibrosis aged 2-19 with CF.

Interventions

Live-attenuated intranasal influenza vaccine (LAIV) for seasonal immunization. Vaccinees were followed prospectively for 55 days after vaccination (day 0)

Outcome measures

Information on adverse events was collected. Bayesian change-point analysis was used to identify the risk period following LAIV during which participants had a higher risk of reporting adverse events.

Main results

There was a higher risk of reporting serious adverse events (SAEs) (aIRR 1.45, 95% CrI (0.29, 5.17)) and solicited symptoms during days 0-6 of follow-up compared to control period days 7-55. However, most SAEs were not causally related to LAIV and the solicited symptom episodes were brief, usually lasting 1-2 days. There was no increased risk of antibiotic prescriptions for respiratory conditions in the risk vs. control periods (aIRR 0.48, 95% CrI (0.23, 0.91)).

Authors' conclusions

Adverse events were most common 0-6 days after LAIV administration but were generally benign and self-limiting. Pulmonary exacerbations did not increase in frequency.

Keywords: Adolescent; Child; Immunization; Infant; Infection; Influenza A virus; pharmacological_intervention; prevention; Respiratory Tract Diseases; Respiratory Tract Infections; Virus; Intramuscular; Intranasal;