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Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age.
Vaccine. 2008 Sep 12; 26 Suppl 4:D10-6.V

Abstract

Three pivotal trials supported the licensure of live attenuated influenza vaccine (LAIV) for children > or =2 years of age: 2 placebo-controlled studies each conducted over 2 seasons, and a 1-year trial comparing LAIV with trivalent inactivated influenza vaccine (TIV). Analyses were conducted to evaluate the safety and efficacy of LAIV in the subgroup of children > or =2 years of age from these trials. Efficacy was demonstrated compared with placebo in children aged 2-7 years in seasons with matched strains (69.2% [95% CI: 52.7, 80.4] and 94.6% [95% CI: 88.6, 97.5]), seasons with primarily mismatched strains (87% [95% CI: 77.0, 92.6]), and during late season epidemics (73.8% [95% CI: 40.4, 89.4]). Compared with TIV recipients, LAIV recipients aged 2-5 years had 52.5% (95% CI: 26.7, 68.7) and 54.4% (95% CI: 41.8, 64.5) fewer cases of influenza illness against matched and mismatched strains, respectively. No unusual or unexpected adverse reactions were noted. The adverse reactions most commonly associated with LAIV were runny nose/nasal congestion and low-grade fever. Hospitalizations and medically significant wheezing were increased in children 6-11 and 6-23 months of age who received LAIV, respectively, but were not increased in children 2-5 years of age.

Authors+Show Affiliations

Saint Louis University Medical Center, St. Louis, MO, USA. belsherb@slu.eduNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18611422

Citation

Belshe, Robert B., et al. "Safety and Efficacy of Live Attenuated Influenza Vaccine in Children 2-7 Years of Age." Vaccine, vol. 26 Suppl 4, 2008, pp. D10-6.
Belshe RB, Ambrose CS, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine. 2008;26 Suppl 4:D10-6.
Belshe, R. B., Ambrose, C. S., & Yi, T. (2008). Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine, 26 Suppl 4, D10-6. https://doi.org/10.1016/j.vaccine.2008.06.083
Belshe RB, Ambrose CS, Yi T. Safety and Efficacy of Live Attenuated Influenza Vaccine in Children 2-7 Years of Age. Vaccine. 2008 Sep 12;26 Suppl 4:D10-6. PubMed PMID: 18611422.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. AU - Belshe,Robert B, AU - Ambrose,Christopher S, AU - Yi,Tingting, PY - 2008/04/21/received PY - 2008/06/18/revised PY - 2008/06/18/accepted PY - 2008/7/10/pubmed PY - 2009/3/11/medline PY - 2008/7/10/entrez SP - D10 EP - 6 JF - Vaccine JO - Vaccine VL - 26 Suppl 4 N2 - Three pivotal trials supported the licensure of live attenuated influenza vaccine (LAIV) for children > or =2 years of age: 2 placebo-controlled studies each conducted over 2 seasons, and a 1-year trial comparing LAIV with trivalent inactivated influenza vaccine (TIV). Analyses were conducted to evaluate the safety and efficacy of LAIV in the subgroup of children > or =2 years of age from these trials. Efficacy was demonstrated compared with placebo in children aged 2-7 years in seasons with matched strains (69.2% [95% CI: 52.7, 80.4] and 94.6% [95% CI: 88.6, 97.5]), seasons with primarily mismatched strains (87% [95% CI: 77.0, 92.6]), and during late season epidemics (73.8% [95% CI: 40.4, 89.4]). Compared with TIV recipients, LAIV recipients aged 2-5 years had 52.5% (95% CI: 26.7, 68.7) and 54.4% (95% CI: 41.8, 64.5) fewer cases of influenza illness against matched and mismatched strains, respectively. No unusual or unexpected adverse reactions were noted. The adverse reactions most commonly associated with LAIV were runny nose/nasal congestion and low-grade fever. Hospitalizations and medically significant wheezing were increased in children 6-11 and 6-23 months of age who received LAIV, respectively, but were not increased in children 2-5 years of age. SN - 0264-410X UR - https://www.unboundmedicine.com/medline/citation/18611422/Safety_and_efficacy_of_live_attenuated_influenza_vaccine_in_children_2_7_years_of_age_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(08)00831-1 DB - PRIME DP - Unbound Medicine ER -