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Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma.
Pediatr Infect Dis J. 2006 Oct; 25(10):860-9.PI

Abstract

BACKGROUND

Despite their potential for increased morbidity, 75% to 90% of asthmatic children do not receive influenza vaccination. Live attenuated influenza vaccine (LAIV), a cold-adapted, temperature-sensitive, trivalent influenza vaccine, is approved for prevention of influenza in healthy children 5 to 19 years of age. LAIV has been studied in only a small number of children with asthma.

METHODS

Children 6 to 17 years of age, with a clinical diagnosis of asthma, received a single dose of either intranasal CAIV-T (an investigational refrigerator-stable formulation of LAIV; n = 1114) or injectable trivalent inactivated influenza vaccine (TIV; n = 1115) in this randomized, open-label study during the 2002-2003 influenza season. Participants were followed up for culture-confirmed influenza illness, respiratory outcome, and safety.

RESULTS

The incidence of community-acquired culture-confirmed influenza illness was 4.1% (CAIV-T) versus 6.2% (TIV), demonstrating a significantly greater relative efficacy of CAIV-T versus TIV of 34.7% (90% confidence interval [CI] 9.4%-53.2%; 95% CI = 3.9%-56.0%). There were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate findings, asthma symptom scores, or nighttime awakening scores. The incidence of runny nose/nasal congestion was higher for CAIV-T (66.2%) than TIV (52.5%) recipients. Approximately 70% of TIV recipients reported injection site reactions.

CONCLUSIONS

CAIV-T was well tolerated in children and adolescents with asthma. There was no evidence of a significant increase in adverse pulmonary outcomes for CAIV-T compared with TIV. CAIV-T had a significantly greater relative efficacy of 35% compared with TIV in this high-risk population.

Authors+Show Affiliations

Northfield Health Centre, Birmingham, United Kingdom.No 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 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)

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

Language

eng

PubMed ID

17006278

Citation

Fleming, Douglas M., et al. "Comparison of the Efficacy and Safety of Live Attenuated Cold-adapted Influenza Vaccine, Trivalent, With Trivalent Inactivated Influenza Virus Vaccine in Children and Adolescents With Asthma." The Pediatric Infectious Disease Journal, vol. 25, no. 10, 2006, pp. 860-9.
Fleming DM, Crovari P, Wahn U, et al. Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J. 2006;25(10):860-9.
Fleming, D. M., Crovari, P., Wahn, U., Klemola, T., Schlesinger, Y., Langussis, A., Øymar, K., Garcia, M. L., Krygier, A., Costa, H., Heininger, U., Pregaldien, J. L., Cheng, S. M., Skinner, J., Razmpour, A., Saville, M., Gruber, W. C., & Forrest, B. (2006). Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. The Pediatric Infectious Disease Journal, 25(10), 860-9.
Fleming DM, et al. Comparison of the Efficacy and Safety of Live Attenuated Cold-adapted Influenza Vaccine, Trivalent, With Trivalent Inactivated Influenza Virus Vaccine in Children and Adolescents With Asthma. Pediatr Infect Dis J. 2006;25(10):860-9. PubMed PMID: 17006278.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. AU - Fleming,Douglas M, AU - Crovari,Pietro, AU - Wahn,Ulrich, AU - Klemola,Timo, AU - Schlesinger,Yechiel, AU - Langussis,Alexangros, AU - Øymar,Knut, AU - Garcia,Maria Luz, AU - Krygier,Alain, AU - Costa,Herculano, AU - Heininger,Ulrich, AU - Pregaldien,Jean-Louis, AU - Cheng,Sheau-Mei, AU - Skinner,Jonathan, AU - Razmpour,Ahmad, AU - Saville,Melanie, AU - Gruber,William C, AU - Forrest,Bruce, AU - ,, PY - 2006/9/29/pubmed PY - 2006/12/21/medline PY - 2006/9/29/entrez SP - 860 EP - 9 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 25 IS - 10 N2 - BACKGROUND: Despite their potential for increased morbidity, 75% to 90% of asthmatic children do not receive influenza vaccination. Live attenuated influenza vaccine (LAIV), a cold-adapted, temperature-sensitive, trivalent influenza vaccine, is approved for prevention of influenza in healthy children 5 to 19 years of age. LAIV has been studied in only a small number of children with asthma. METHODS: Children 6 to 17 years of age, with a clinical diagnosis of asthma, received a single dose of either intranasal CAIV-T (an investigational refrigerator-stable formulation of LAIV; n = 1114) or injectable trivalent inactivated influenza vaccine (TIV; n = 1115) in this randomized, open-label study during the 2002-2003 influenza season. Participants were followed up for culture-confirmed influenza illness, respiratory outcome, and safety. RESULTS: The incidence of community-acquired culture-confirmed influenza illness was 4.1% (CAIV-T) versus 6.2% (TIV), demonstrating a significantly greater relative efficacy of CAIV-T versus TIV of 34.7% (90% confidence interval [CI] 9.4%-53.2%; 95% CI = 3.9%-56.0%). There were no significant differences between treatment groups in the incidence of asthma exacerbations, mean peak expiratory flow rate findings, asthma symptom scores, or nighttime awakening scores. The incidence of runny nose/nasal congestion was higher for CAIV-T (66.2%) than TIV (52.5%) recipients. Approximately 70% of TIV recipients reported injection site reactions. CONCLUSIONS: CAIV-T was well tolerated in children and adolescents with asthma. There was no evidence of a significant increase in adverse pulmonary outcomes for CAIV-T compared with TIV. CAIV-T had a significantly greater relative efficacy of 35% compared with TIV in this high-risk population. SN - 0891-3668 UR - https://www.unboundmedicine.com/medline/citation/17006278/Comparison_of_the_efficacy_and_safety_of_live_attenuated_cold_adapted_influenza_vaccine_trivalent_with_trivalent_inactivated_influenza_virus_vaccine_in_children_and_adolescents_with_asthma_ L2 - http://dx.doi.org/10.1097/01.inf.0000237797.14283.cf DB - PRIME DP - Unbound Medicine ER -