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Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children.
Pediatr Infect Dis J 2012; 31(7):745-51PI

Abstract

BACKGROUND

Influenza B viruses from 2 lineages cocirculate annually. Because the single B strain contained in trivalent vaccines may not match the major circulating strain, adding a second B virus could enhance protection. This study compared the safety and immunogenicity of an investigational quadrivalent Ann Arbor strain live attenuated influenza vaccine (Q/LAIV) with that of 2 trivalent vaccines (T/LAIV), each containing a B strain from a different lineage.

METHODS

This randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV in children 2-17 years of age by comparing postdose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or 1 of 2 T/LAIV vaccines. Those subjects who were 9-17 years of age received 1 dose, and those 2-8 years of age received 2 doses 1 month apart. Serum immune responses were evaluated 1 month after dose 1 (dose 2 for influenza vaccine-naive subjects aged 2-8 years).

RESULTS

Q/LAIV was noninferior to T/LAIV: upper bounds for all four 95% confidence intervals for the postdose geometric mean titer ratios (T/LAIV divided by Q/LAIV) were ≤1.5, the predefined noninferiority margin. The overall seroresponse rates (4-fold rise) were comparable between treatment groups. Safety events were comparable, except that fever was more common after dose 1 in Q/LAIV subjects (5.1%) than in T/LAIV subjects (3.1%) 2-8 years of age.

CONCLUSIONS

The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children aged 2-17 years; safety was also comparable. Q/LAIV may broaden the protection against influenza B strains provided by current trivalent influenza vaccines.

Authors+Show Affiliations

Kentucky Pediatric and Adult Research, Bardstown, KY, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22466322

Citation

Block, Stan L., et al. "Immunogenicity and Safety of a Quadrivalent Live Attenuated Influenza Vaccine in Children." The Pediatric Infectious Disease Journal, vol. 31, no. 7, 2012, pp. 745-51.
Block SL, Falloon J, Hirschfield JA, et al. Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children. Pediatr Infect Dis J. 2012;31(7):745-51.
Block, S. L., Falloon, J., Hirschfield, J. A., Krilov, L. R., Dubovsky, F., Yi, T., & Belshe, R. B. (2012). Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children. The Pediatric Infectious Disease Journal, 31(7), pp. 745-51. doi:10.1097/INF.0b013e31825687b0.
Block SL, et al. Immunogenicity and Safety of a Quadrivalent Live Attenuated Influenza Vaccine in Children. Pediatr Infect Dis J. 2012;31(7):745-51. PubMed PMID: 22466322.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children. AU - Block,Stan L, AU - Falloon,Judith, AU - Hirschfield,Jeffrey A, AU - Krilov,Leonard R, AU - Dubovsky,Filip, AU - Yi,Tingting, AU - Belshe,Robert B, PY - 2012/4/3/entrez PY - 2012/4/3/pubmed PY - 2012/10/4/medline SP - 745 EP - 51 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 31 IS - 7 N2 - BACKGROUND: Influenza B viruses from 2 lineages cocirculate annually. Because the single B strain contained in trivalent vaccines may not match the major circulating strain, adding a second B virus could enhance protection. This study compared the safety and immunogenicity of an investigational quadrivalent Ann Arbor strain live attenuated influenza vaccine (Q/LAIV) with that of 2 trivalent vaccines (T/LAIV), each containing a B strain from a different lineage. METHODS: This randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared with T/LAIV in children 2-17 years of age by comparing postdose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or 1 of 2 T/LAIV vaccines. Those subjects who were 9-17 years of age received 1 dose, and those 2-8 years of age received 2 doses 1 month apart. Serum immune responses were evaluated 1 month after dose 1 (dose 2 for influenza vaccine-naive subjects aged 2-8 years). RESULTS: Q/LAIV was noninferior to T/LAIV: upper bounds for all four 95% confidence intervals for the postdose geometric mean titer ratios (T/LAIV divided by Q/LAIV) were ≤1.5, the predefined noninferiority margin. The overall seroresponse rates (4-fold rise) were comparable between treatment groups. Safety events were comparable, except that fever was more common after dose 1 in Q/LAIV subjects (5.1%) than in T/LAIV subjects (3.1%) 2-8 years of age. CONCLUSIONS: The immunogenicity of Q/LAIV was noninferior to that of T/LAIV in children aged 2-17 years; safety was also comparable. Q/LAIV may broaden the protection against influenza B strains provided by current trivalent influenza vaccines. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/22466322/Immunogenicity_and_safety_of_a_quadrivalent_live_attenuated_influenza_vaccine_in_children_ L2 - http://dx.doi.org/10.1097/INF.0b013e31825687b0 DB - PRIME DP - Unbound Medicine ER -