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Randomized Controlled Trial
. 2011 Nov;5(6):389-97.
doi: 10.1111/j.1750-2659.2011.00243.x. Epub 2011 Apr 4.

An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years

Christopher S Ambrose  1 , Tingting Yi, Judith Falloon
Affiliations
Randomized Controlled Trial

An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years

Christopher S Ambrose et al. Influenza Other Respir Viruses. 2011 Nov.

Abstract

Background: Trivalent, Ann Arbor strain, live attenuated influenza vaccine (LAIV) is approved in several countries for use in eligible children aged ≥2 years.

Objective: To describe the safety of Ann Arbor strain LAIV in children aged 2-17 years.

Methods: An integrated analysis of randomized, controlled trials of LAIV.

Results: A total of 4245 and 10,693 children received ≥1 dose of LAIV in year 1 of 6 trivalent inactivated influenza vaccine (TIV)-controlled and 14 placebo-controlled studies, respectively; 3212 children were revaccinated in year 2 of 4 placebo-controlled studies. Compared with placebo for days 0-10 post-vaccination, LAIV recipients exhibited increased runny/stuffy nose (+7%), headache (+7%), and tiredness/decreased activity (+2%) after dose 1; and a higher rate of decreased appetite (+4%) after year 2 revaccination. Compared with TIV, only runny/stuffy nose was increased (dose 1, +12%; dose 2, +4%). Compared with initial vaccination, LAIV reactogenicity was lower after dose 2 in year 1 and revaccination in year 2. Unsolicited adverse events (AEs) increased with LAIV in some comparisons were headache, nasal congestion/rhinorrhea, rhinitis, and pyrexia; ear pain and lower respiratory illness were decreased. There was no evidence of an increase in any potential vaccine-related serious AE in LAIV recipients. Among children aged 2-17 years and specifically aged 24-35 months, there was no evidence that lower respiratory illness or wheezing illness occurred at a higher rate in LAIV recipients.

Conclusion: This analysis supports the safety of Ann Arbor strain LAIV in children aged 2-17 years and provides a consensus assessment of events expected after vaccination.

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Figures

Figure 1
Figure 1
Solicited reactogenicity events days 0–10 post‐vaccination in TIV‐controlled studies. *P < 0·05, unadjusted for multiplicity. LAIV, live attenuated influenza vaccine; TIV, trivalent inactivated influenza vaccine.
Figure 2
Figure 2
Solicited reactogenicity events days 0–10 post‐vaccination in year 1 of placebo‐controlled studies. *P < 0·05, unadjusted for multiplicity. LAIV, live attenuated influenza vaccine.
Figure 3
Figure 3
Solicited reactogenicity events days 0–10 post‐vaccination in year 2 of placebo‐controlled studies. Data for headache, muscle ache, and chills were not collected in year 2 of any studies. *P < 0·05, unadjusted for multiplicity. LAIV, live attenuated influenza vaccine.
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