Herve Caspard1, Manjusha Gaglani2, Lydia Clipper3, Edward A Belongia4, Huong Q McLean5, Marie R Griffin6, H Keipp Talbot7, Katherine A Poehling8, Timothy R Peters9, Naomi Veney10, Christopher S Ambrose11. 1. AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, United States. Electronic address: caspardh@medimmune.com. 2. Baylor Scott & White Health, Texas A&M Health Science Center College of Medicine, 2401 South 31st Street, Temple, TX 76508, United States. Electronic address: mgaglani@sw.org. 3. Baylor Scott & White Health, Texas A&M Health Science Center College of Medicine, 2401 South 31st Street, Temple, TX 76508, United States. Electronic address: lclipper@sw.org. 4. Marshfield Clinic Research Foundation, 1000 N. Oak Avenue, Marshfield, WI 54449, United States. Electronic address: belongia.edward@marshfieldclinic.org. 5. Marshfield Clinic Research Foundation, 1000 N. Oak Avenue, Marshfield, WI 54449, United States. Electronic address: mclean.huong@marshfieldclinic.org. 6. Vanderbilt University Medical Center, 1161 21st Avenue S, Nashville, TN 37232, United States. Electronic address: marie.griffin@vanderbilt.edu. 7. Vanderbilt University Medical Center, 1161 21st Avenue S, Nashville, TN 37232, United States. Electronic address: keipp.talbot@vanderbilt.edu. 8. Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC 27157, United States. Electronic address: kpoehlin@wfubmc.edu. 9. Wake Forest School of Medicine, 1 Medical Center Blvd, Winston-Salem, NC 27157, United States. Electronic address: tpeters@wakehealth.edu. 10. AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, United States. Electronic address: veneyn@medimmune.com. 11. AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, United States. Electronic address: ambrosec@medimmune.com.
Abstract
BACKGROUND: A postmarketing observational study was initiated to evaluate quadrivalent live attenuated influenza vaccine (LAIV) effectiveness in children aged 2-17 years in the United States. METHODS: Children and adolescents aged 2-17 years seeking outpatient care for febrile acute respiratory illness <5 days duration were enrolled at 4 geographically diverse sites during the 2013-2014 influenza season. Nasal swabs were tested for influenza using reverse transcription polymerase chain reaction. Vaccination status was documented from medical records or immunization registries. Children who received ≥1 dose of influenza vaccine ≥14 days before study visit were considered vaccinated. Vaccine effectiveness (VE) was estimated as 100×(1-adjusted odds ratio), where the odds of interest are the odds of vaccine exposure among influenza cases and test-negative controls. RESULTS: In total, 1033 children and adolescents were included in the analysis. Influenza was detected in 14% (145/1033) of all children, with 74% (108/145) of the influenza cases due to A/H1N1pdm09 strains, 21% (31) to influenza B, and 4% (6) to influenza H3N2. LAIV did not show significant effectiveness against A/H1N1pdm09 (VE 13% [95% CI: -55 to 51]) but was effective against B/Yamagata strains (82% [95% CI: 12-96]). Inactivated influenza vaccine was effective against A/H1N1pdm09 (74% [95% CI: 50-86]) and B/Yamagata (70% [95% CI: 18-89]). CONCLUSIONS: LAIV provided significant protection against B/Yamagata influenza but not against A/H1N1pdm09 in children aged 2-17 years in 2013-2014, resulting in a proposed change of the 2015-2016 formulation with a new and more heat-stable A/H1N1pdm09 LAIV strain.
BACKGROUND: A postmarketing observational study was initiated to evaluate quadrivalent live attenuated influenza vaccine (LAIV) effectiveness in children aged 2-17 years in the United States. METHODS:Children and adolescents aged 2-17 years seeking outpatient care for febrile acute respiratory illness <5 days duration were enrolled at 4 geographically diverse sites during the 2013-2014 influenza season. Nasal swabs were tested for influenza using reverse transcription polymerase chain reaction. Vaccination status was documented from medical records or immunization registries. Children who received ≥1 dose of influenza vaccine ≥14 days before study visit were considered vaccinated. Vaccine effectiveness (VE) was estimated as 100×(1-adjusted odds ratio), where the odds of interest are the odds of vaccine exposure among influenza cases and test-negative controls. RESULTS: In total, 1033 children and adolescents were included in the analysis. Influenza was detected in 14% (145/1033) of all children, with 74% (108/145) of the influenza cases due to A/H1N1pdm09 strains, 21% (31) to influenza B, and 4% (6) to influenza H3N2. LAIV did not show significant effectiveness against A/H1N1pdm09 (VE 13% [95% CI: -55 to 51]) but was effective against B/Yamagata strains (82% [95% CI: 12-96]). Inactivated influenza vaccine was effective against A/H1N1pdm09 (74% [95% CI: 50-86]) and B/Yamagata (70% [95% CI: 18-89]). CONCLUSIONS: LAIV provided significant protection against B/Yamagata influenza but not against A/H1N1pdm09 in children aged 2-17 years in 2013-2014, resulting in a proposed change of the 2015-2016 formulation with a new and more heat-stable A/H1N1pdm09 LAIV strain.
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