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Antimicrobial Agents and Chemotherapy, November 2007, p. 4001-4008, Vol. 51, No. 11
0066-4804/07/$08.00+0     doi:10.1128/AAC.00517-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Comparative Immunogenicities of Frozen and Refrigerated Formulations of Live Attenuated Influenza Vaccine in Healthy Subjects{triangledown}

Stan L. Block,1* Keith S. Reisinger,2 Micki Hultquist,3 Robert E. Walker,3 for the CAIV-T Study Group

Kentucky Pediatric Research, Bardstown, Kentucky,1 Primary Physicians Research, Pittsburgh, Pennsylvania,2 MedImmune, Gaithersburg, Maryland3

Received 19 April 2007/ Returned for modification 14 June 2007/ Accepted 17 August 2007

The frozen version of live attenuated influenza vaccine (LAIV; FluMist) was compared with a newly licensed, refrigerated formulation, the cold-adapted influenza vaccine, trivalent (CAIV-T), for their immunogenicity, safety, and tolerability in healthy subjects 5 to 49 years of age. Eligible subjects were randomized 1:1 to receive CAIV-T or frozen LAIV. Subjects 5 to 8 years of age received two doses of vaccine 46 to 60 days apart; subjects 9 to 49 years of age received one dose of vaccine. Equivalent immunogenicities were defined as serum hemagglutination inhibition (HAI) geometric mean titer (GMT) ratios >0.5 and <2.0 for each of the three vaccine-specific strains. A total of 376 subjects 5 to 8 years of age and 566 subjects 9 to 49 years of age were evaluable. Postvaccination HAI GMT ratios were equivalent for CAIV-T and LAIV. The GMT ratios of CAIV-T/LAIV for the H1N1, H3N2, and B strains were 1.24, 1.02, and 1.00, respectively, for the 5- to 8-year-old age group and 1.14, 1.12, and 0.96, respectively, for the 9- to 49-year-old age group. Seroresponse/seroconversion rates (fourfold or greater rise) were similar in both age groups for each of the three vaccine strains. Within 28 days, the most frequent reactogenicity event in the CAIV-T and LAIV groups was runny nose/nasal congestion, which occurred at higher rates after dose 1 (44% and 42%, respectively) than after dose 2 (41% and 29%, respectively) in the 5- to 8-year-old group. Otherwise, the rates of adverse events (AEs) were similar between the treatment groups and the two age cohorts, with no serious AEs related to the study vaccines. The immunogenicities, reactogenicity events, and AEs were comparable for refrigerated CAIV-T and frozen LAIV.

* Corresponding author. Mailing address: Kentucky Pediatric Research, 201 S. 5th St., Bardstown, KY 40004-1142. Phone: (502) 349-1569. Fax: (502) 348-2793. E-mail: slblock{at}pol.net

{triangledown} Published ahead of print on 27 August 2007.

Antimicrobial Agents and Chemotherapy, November 2007, p. 4001-4008, Vol. 51, No. 11
0066-4804/07/$08.00+0     doi:10.1128/AAC.00517-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

  • Wang, Z., Tobler, S., Roayaei, J., Eick, A. (2009). Live Attenuated or Inactivated Influenza Vaccines and Medical Encounters for Respiratory Illnesses Among US Military Personnel. JAMA 301: 945-953 [Abstract] [Full Text]  


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