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Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care.
Pediatrics. 2006 Dec; 118(6):2298-312.Ped

Abstract

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.

Authors+Show Affiliations

Tampere University Medical School/FM3, Biokatu 10, 33520 Tampere, Finland. timo.vesikari@uta.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

17142512

Citation

Vesikari, Timo, et al. "Safety, Efficacy, and Effectiveness of Cold-adapted Influenza Vaccine-trivalent Against Community-acquired, Culture-confirmed Influenza in Young Children Attending Day Care." Pediatrics, vol. 118, no. 6, 2006, pp. 2298-312.
Vesikari T, Fleming DM, Aristegui JF, et al. Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care. Pediatrics. 2006;118(6):2298-312.
Vesikari, T., Fleming, D. M., Aristegui, J. F., Vertruyen, A., Ashkenazi, S., Rappaport, R., Skinner, J., Saville, M. K., Gruber, W. C., & Forrest, B. D. (2006). Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care. Pediatrics, 118(6), 2298-312.
Vesikari T, et al. Safety, Efficacy, and Effectiveness of Cold-adapted Influenza Vaccine-trivalent Against Community-acquired, Culture-confirmed Influenza in Young Children Attending Day Care. Pediatrics. 2006;118(6):2298-312. PubMed PMID: 17142512.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety, efficacy, and effectiveness of cold-adapted influenza vaccine-trivalent against community-acquired, culture-confirmed influenza in young children attending day care. AU - Vesikari,Timo, AU - Fleming,Douglas M, AU - Aristegui,Javier F, AU - Vertruyen,Andre, AU - Ashkenazi,Shai, AU - Rappaport,Ruth, AU - Skinner,Jonathan, AU - Saville,Melanie K, AU - Gruber,William C, AU - Forrest,Bruce D, AU - ,, PY - 2006/12/5/pubmed PY - 2006/12/21/medline PY - 2006/12/5/entrez SP - 2298 EP - 312 JF - Pediatrics JO - Pediatrics VL - 118 IS - 6 N2 - 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. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/17142512/Safety_efficacy_and_effectiveness_of_cold_adapted_influenza_vaccine_trivalent_against_community_acquired_culture_confirmed_influenza_in_young_children_attending_day_care_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&amp;pmid=17142512 DB - PRIME DP - Unbound Medicine ER -