Published online December 1, 2006
PEDIATRICS Vol. 118 No. 6 December 2006, pp. 2298-2312 (doi:10.1542/10.1542/peds.2006-0725)

This Article Full Text Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via ISI Web of Science (15) Citing Articles via Google Scholar Google Scholar Articles by Vesikari, T. Search for Related Content PubMed PubMed Citation Articles by Vesikari, T. Related Collections Infectious Disease & Immunity Social Bookmarking                         What's this?

ARTICLE

Safety, Efficacy, and Effectiveness of Cold-Adapted Influenza Vaccine-Trivalent Against Community-Acquired, Culture-Confirmed Influenza in Young Children Attending Day Care

Timo Vesikari, MD^a, Douglas M. Fleming, MB, ChB, PhD^b, Javier F. Aristegui, MD^c, Andre Vertruyen, MD^d, Shai Ashkenazi, MD^e, Ruth Rappaport, PhD^f, Jonathan Skinner, PhD^f, Melanie K. Saville, MB, BS^g, William C. Gruber, MD^f, Bruce D. Forrest, MD^f for the CAIV-T Pediatric Day Care Clinical Trial Network

^a Tampere University Medical School, Tampere, Finland
^b Northfield Health Centre, Birmingham, United Kingdom
^c Hospital de Basurto, Bilbao, Spain
^d St Vincentius Hospital, Antwerp, Belgium
^e Schneider Children’s Hospital, Petah Tikva, Israel
^f Wyeth Vaccines Research, Pearl River, New York
^g Wyeth Vaccines Research, Taplow, United Kingdom

OBJECTIVE. The goal was to evaluate the safety, tolerability, and efficacy of an investigational, refrigerator-stable formulation of live attenuated influenza vaccine (cold-adapted influenza vaccine-trivalent) against culture-confirmed influenza, acute otitis media, and effectiveness outcomes in young children in day care over 2 consecutive influenza seasons.

METHODS. Children 6 to <36 months of age who were attending day care were assigned randomly in year 1 to receive 2 doses of vaccine or placebo intranasally, 35 ± 7 days apart. In year 2, subjects received 1 dose of the same treatment as in year 1.

RESULTS. A total of 1616 subjects (vaccine: 951 subjects; placebo: 665 subjects) in year 1 and 1090 subjects (vaccine: 640 subjects; placebo: 450 subjects) in year 2 were able to be evaluated for efficacy. The mean age at first vaccination was 23.4 ± 7.9 months. In year 1, the overall efficacy of the vaccine against influenza subtypes similar to the vaccine was 85.4%; efficacy was 91.8% against A/H1N1 and 72.6% against B. In year 2, the overall efficacy was 88.7%; efficacy was 90.0% against H1N1, 90.3% against A/H3N2, and 81.7% against B. Efficacy against all episodes of acute otitis media associated with culture-confirmed influenza was 90.6% in year 1 and 97.0% in year 2. Runny nose or nasal discharge after dose 1 in year 1 was the only reactogenicity event that was significantly more frequent with cold-adapted influenza vaccine-trivalent (82.3%) than placebo (75.4%).

CONCLUSIONS. Cold-adapted influenza vaccine-trivalent was well tolerated and effective in preventing culture-confirmed influenza illness in children as young as 6 months of age who attended day care.

---

Key Words: influenza • cold-adapted influenza vaccine-trivalent • children

Abbreviations: AE—adverse event • AOM—acute otitis media • CAIV-T—cold-adapted influenza vaccine-trivalent • CI—confidence interval • LAIV—live attenuated influenza vaccine • PCR—polymerase chain reaction • PP—per protocol • TIV—trivalent influenza vaccine

---

Accepted Aug 24, 2006.

CiteULike    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				N. E. Basta, M. E. Halloran, L. Matrajt, and I. M. Longini Jr. Estimating Influenza Vaccine Efficacy From Challenge and Community-based Study Data Am. J. Epidemiol., December 15, 2008; 168(12): 1343 - 1352. [Abstract] [Full Text] [PDF]

				B. D. Forrest, M. W. Pride, A. J. Dunning, M. R. Z. Capeding, T. Chotpitayasunondh, J. S. Tam, R. Rappaport, J. H. Eldridge, and W. C. Gruber Correlation of Cellular Immune Responses with Protection against Culture-Confirmed Influenza Virus in Young Children Clin. Vaccine Immunol., July 1, 2008; 15(7): 1042 - 1053. [Abstract] [Full Text] [PDF]

				T. Jartti and O. Ruuskanen Influenza Virus and Acute Asthma in Children Pediatrics, May 1, 2008; 121(5): 1079 - 1080. [Full Text] [PDF]

				T. Nolan, D. I. Bernstein, S. L. Block, M. Hilty, H. L. Keyserling, C. Marchant, H. Marshall, P. Richmond, R. Yogev, J. Cordova, et al. Safety and Immunogenicity of Concurrent Administration of Live Attenuated Influenza Vaccine With Measles-Mumps-Rubella and Varicella Vaccines to Infants 12 to 15 Months of Age Pediatrics, March 1, 2008; 121(3): 508 - 516. [Abstract] [Full Text] [PDF]

				J. Schmier, S. Li, J. C. King Jr., K. Nichol, and P. J. Mahadevia Benefits And Costs Of Immunizing Children Against Influenza At School: An Economic Analysis Based On A Large-Cluster Controlled Clinical Trial Health Aff., March 1, 2008; 27(2): w96 - w104. [Abstract] [Full Text] [PDF]

				T. Vesikari, A. Karvonen, H. M. Smith, A. Dunning, A. Razmpour, M. K. Saville, W. C. Gruber, and B. D. Forrest Safety and Tolerability of Cold-Adapted Influenza Vaccine, Trivalent, in Infants Younger Than 6 Months of Age Pediatrics, March 1, 2008; 121(3): e568 - e573. [Abstract] [Full Text] [PDF]

				E. N. Lewis, M. R. Griffin, P. G. Szilagyi, Y. Zhu, K. M. Edwards, and K. A. Poehling Childhood Influenza: Number Needed to Vaccinate to Prevent 1 Hospitalization or Outpatient Visit Pediatrics, September 1, 2007; 120(3): 467 - 472. [Abstract] [Full Text] [PDF]

				Other articles noted Evid. Based Med., April 1, 2007; 12(2): 63 - 64. [Full Text] [PDF]