Safety of cold-adapted live attenuated influenza vaccine in a large cohort of children and adolescents

2004 ◽  
Vol 23 (2) ◽  
pp. 138-144 ◽  
Author(s):  
RANDY BERGEN ◽  
STEVE BLACK ◽  
HENRY SHINEFIELD ◽  
EDWIN LEWIS ◽  
PAULA RAY ◽  
...  
Drug Safety ◽  
2016 ◽  
Vol 39 (4) ◽  
pp. 323-333 ◽  
Author(s):  
Rhian McNaughton ◽  
Elizabeth Lynn ◽  
Vicki Osborne ◽  
Abigail Coughtrie ◽  
Deborah Layton ◽  
...  

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e023118 ◽  
Author(s):  
Herve Caspard ◽  
Amy Steffey ◽  
Raburn M Mallory ◽  
Christopher S Ambrose

ObjectivesTo assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.DesignNon-interventional cohort study.SettingEngland during 2013–2014 and 2014–2015 influenza seasons.ParticipantsLAIV recipients identified from the Clinical Practice Research Datalink, aged 2–17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls.Primary outcome measuresPrimary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.Results11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013–2014 influenza season and 6745 received the quadrivalent formulation during the 2014–2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013–2014 and 231 (95% CI 198 to 267) in season 2014–2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013–2014, 0.90 (95% CI 0.76 to 1.07) in season 2014–2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013–2014, 0.42 (95% CI 0.35 to 0.51) in season 2014–2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration.ConclusionsThis study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline.Trial registration numberEUPAS18527.


2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Chiara Gasparini ◽  
Miriam Acunzo ◽  
Andrea Biuso ◽  
Stefania Roncaglia ◽  
Francesca Migliavacca ◽  
...  

Abstract Background In Italy only recently, for the 2020–21 season, has the flu vaccination been extended to all children. A quadrivalent live attenuated influenza vaccine (qLAIV) was administered to children aged 2–17 years for the first time. We registered the number and severity of adverse reactions to (Fluenz Tetra™) and the factors influencing them, evaluated uniformity of access to care and assessed the degree of satisfaction with the vaccination of both parents and health care providers, in order to improve the 2021–22 vaccination program. Methods On vaccination day, a questionnaire was given out to collect information about the children and their parents. Between 1 and 3 months later, the parents were contacted to record any adverse reactions following (Fluenz Tetra™) and rate the degree of satisfaction. Results We received data of 3226 children from 2152 families. Adverse events were reported in 24.8% of children: 80.6% mild, 18.1% moderate and 1.3% significant. The most common were rhinitis (52.5%) and fever (24.4%). Statistical analysis performed with a multiple regression model, showed that children aged 2–5 years have an increased risk of adverse events compared to both 6–10 years old (aRR 1.7, 95% CI 1.5–1.9, p < 0. 001) and 11–17 years old (aRR 1.5, 95% CI 1–2.2, p = 0.051). Most families chose to vaccinate their children to protect them and because they were concerned about Covid19. The main channel through which parents became aware of a new flu vaccination was word-of-mouth (39.8%), which occurred mostly among parents of the same school group, followed by information from the child’s doctor (30.6%), the Internet (26.9%), personal research (15%), newspapers (4%), telecommunications (7.5%) and other (2.6%). Most parents (83.3%) were very satisfied and intend to vaccinate their children with qLAIV again (83.8%). The majority of operators (93%) considered the experience as excellent and are willing to repeat it (94.6%). Conclusion (Fluenz Tetra™) proved to be easy to administer and the degree of satisfaction was high among both health workers and parents. Considering its substantial safety profile especially in school-age children and adolescents, all these aspects make the nasal qLAIV optimal for widespread immunization. Schools offer the best setting to reach more families and physicians should be actively involved.


2018 ◽  
Vol 9 ◽  
Author(s):  
Yo Han Jang ◽  
Joo Young Kim ◽  
Young Ho Byun ◽  
Ahyun Son ◽  
Jeong-Yoon Lee ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document