Karen L Kotloff1, Natasha B Halasa, Christopher J Harrison, Janet A Englund, Emmanuel B Walter, James C King, C Buddy Creech, Sara A Healy, Rowena J Dolor, Ina Stephens, Kathryn M Edwards, Diana L Noah, Heather Hill, Mark Wolff. 1. From the *Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD; †Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University School of Medicine, Nashville, TN; ‡Department of Pediatrics, Pediatric Infectious Diseases Section, Children's Mercy Hospital and Clinics, and the University of Missouri-Kansas City, Kansas City, MO; §Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington and Seattle Children's Hospital, Seattle, WA; ¶Department of Pediatrics, Duke Clinical Vaccine Unit, Duke University School of Medicine, Durham, NC; ‖Division of General Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD; **Department of Medicine, Duke University School of Medicine, Durham, NC; ††Southern Research Institute, Birmingham, AL; and ‡‡EMMES Corp, Department of Vaccines and Infectious Diseases, Rockville, MD.
Abstract
BACKGROUND: As the influenza A H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. METHODS:Children received 2 doses of approximately 15 or 30 µg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. RESULTS: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 µg dosage elicited a seroprotective hemagglutination inhibition (≥ 1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 µg vaccine dosage induced similar responses. CONCLUSIONS: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 µg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.
RCT Entities:
BACKGROUND: As the influenzaA H1N1 pandemic emerged in 2009, children were found to experience high morbidity and mortality and were prioritized for vaccination. This multicenter, randomized, double-blind, age-stratified trial assessed the safety and immunogenicity of inactivated influenza A(H1N1)pdm09 vaccine in healthy children aged 6 months to 17 years. METHODS:Children received 2 doses of approximately 15 or 30 µg hemagglutin antigen 21 days apart. Reactogenicity was assessed for 8 days after each dose, adverse events through day 42, and serious adverse events or new-onset chronic illnesses through day 201. Serum hemagglutination inhibition titers were measured on days 0 (prevaccination), 8, 21, 29 and 42. RESULTS: A total of 583 children received the first dose and 571 received the second dose of vaccine. Vaccinations were generally well-tolerated and no related serious adverse events were observed. The 15 µg dosage elicited a seroprotective hemagglutination inhibition (≥ 1:40) in 20%, 47% and 93% of children in the 6-35 month, 3-9 year and 10-17 year age strata 21 days after dose 1 and in 78%, 82% and 98% of children 21 days after dose 2, respectively. The 30 µg vaccine dosage induced similar responses. CONCLUSIONS: The inactivated influenza A(H1N1)pdm09 vaccine exhibited a favorable safety profile at both dosage levels. While a single 15 or 30 µg dose induced seroprotective antibody responses in most children 10-17 years of age, younger children required 2 doses, even when receiving dosages 4- to 6-fold higher than recommended. Well-tolerated vaccines are needed that induce immunity after a single dose for use in young children during influenza pandemics.
Authors: J J Treanor; B E Wilkinson; F Masseoud; J Hu-Primmer; R Battaglia; D O'Brien; M Wolff; G Rabinovich; W Blackwelder; J M Katz Journal: Vaccine Date: 2001-02-08 Impact factor: 3.641
Authors: R B Belshe; C Stevens; G J Gorse; S Buchbinder; K Weinhold; H Sheppard; D Stablein; S Self; J McNamara; S Frey; J Flores; J L Excler; M Klein; R E Habib; A M Duliege; C Harro; L Corey; M Keefer; M Mulligan; P Wright; C Celum; F Judson; K Mayer; D McKirnan; M Marmor; G Woody Journal: J Infect Dis Date: 2001-04-10 Impact factor: 5.226
Authors: William W Thompson; David K Shay; Eric Weintraub; Lynnette Brammer; Carolyn B Bridges; Nancy J Cox; Keiji Fukuda Journal: JAMA Date: 2004-09-15 Impact factor: 56.272
Authors: Sophie Schussek; Valentina Bernasconi; Johan Mattsson; Ulf Alexander Wenzel; Anneli Strömberg; Inta Gribonika; Karin Schön; Nils Y Lycke Journal: Mucosal Immunol Date: 2020-01-20 Impact factor: 7.313