Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women |
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| Institution: | 1. Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA;2. Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA;3. Departments of Medicine, Baylor College of Medicine, Houston, TX, USA;4. Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA;5. Department of Obstetrics & Gynecology, Duke University, Durham, NC, USA;6. Department of Pediatrics, Vanderbilt Vaccine Research Program, Vanderbilt University, Nashville, TN, USA;7. Saint Louis University School of Medicine, St. Louis, MO, USA;8. Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA;9. Emory University Department of Gynecology and Obstetrics and the Emory Vaccine Center, Atlanta, GA, USA;10. University of Iowa, Iowa City, IA, USA;11. The Emmes Corporation, Rockville, MD, USA;1. UMR Vitrome, Institut de Recherche Pour le Développement, Dakar, Senegal;2. Center for Vaccine Innovation and Access, PATH, Seattle, USA;3. Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, USA;4. Kanesa, LLC, Cambridge, USA;5. Senegal Ministry of Health and Social Welfare, Dakar, Senegal;6. Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, USA;7. Division of Global Health Protection, CDC Kenya, Center for Global Health, Centers for Disease Control and Prevention, Nairobi, Kenya;8. Division of Global Health Protection, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, USA;1. Taiwan Centers for Disease Control, 6 Linsen S. Road, Taipei 10050, Taiwan;2. Institute of Biomedical Informatics & Institute of Public Health, National Yang-Ming University, 155 Section 2, Linong Street, Taipei 11221, Taiwan;1. Division of Infectious Diseases, Department of Pediatrics, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan;2. Departments of Pediatrics, National Taiwan University Children''s Hospital and National Taiwan University College of Medicine, Taipei, Taiwan;1. Global Health Center, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;2. Division of Infectious Disease, Cincinnati Children''s Hospital Medical Center, Cincinnati, OH, USA;3. Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA;4. Seattle Children''s Hospital and Research Foundation, University of Washington, Seattle, WA, USA;5. School of Medicine, University of Washington, Seattle, WA, USA;6. Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal;7. Tribhuvan University, Department of Pediatrics and Child Health, Institute of Medicine, Kathmandu, Nepal;8. School of Medicine, University of Washington, Molecular Virology Laboratory, Seattle, WA, USA;9. Harborview Medical Center, Seattle, WA, USA;10. Department of Global Health Milken Institute School of Public Health, George Washington University, Washington, DC, USA;1. School of Pediatrics and Reproductive Health, The University of Adelaide, Adelaide 5005, SA, Australia;2. Joanna Briggs Institute, Faculty of Health Sciences, The University of Adelaide, Adelaide 5005, SA, Australia;3. Women''s and Children''s Hospital, 72 King William Road, North Adelaide 5006, SA, Australia;4. Vaccinology and Immunology Research Trials Unit (VIRTU), Women''s and Children''s Hospital and School of Pediatrics and Reproductive Health & Robinson Institute, The University of Adelaide, Adelaide 5005, SA, Australia;1. Boston Center for Endometriosis, Boston Children’s Hospital and Brigham and Women’s Hospital, Boston, MA, 02115, USA;2. Department of Obstetrics and Gynecology, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, 02115, USA;3. Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ, 85724, USA;4. Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, 98109, USA;5. Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, 98195, USA;6. Division of Adolescent and Young Adult Medicine, Department of Medicine, Boston Children’s Hospital and Harvard Medical School, Boston, MA, 02115, USA;7. Division of Gynecology, Department of Surgery, Boston Children’s Hospital and Harvard Medical School, Boston, MA, 02115, USA;8. Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, 02115, USA;9. Department of Obstetrics, Gynecology, and Reproductive Biology, College of Human Medicine, Michigan State University, Grand Rapids, MA, 49503, USA |
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| Abstract: | BackgroundIn the United States, seasonal inactivated influenza vaccine (IIV) is recommended for pregnant women; however, in early 2009, immunization rates were low, partly due to limited prospective data and concerns about vaccine safety.ObjectiveWe conducted a randomized study of two licensed seasonal trivalent IIVs (IIV3) to assess their safety and immunogenicity in pregnant women.Study DesignIn this prospective, randomized clinical study, 100 pregnant women, 18–39 years of age and ≥14 weeks gestation received a single intramuscular dose of 2008–2009 Fluzone® or Fluarix®. Injection site and systemic reactions were recorded for 7 days after vaccination and serious adverse events (SAEs) and pregnancy outcomes were documented. Serum samples collected before and 28 days after vaccination were tested for hemagglutination inhibition (HAI) antibody levels.ResultsThe majority of the injection site and systemic reactions were mild and self-limited after both vaccines. No fever ≥100 °F was reported. There were no vaccine-associated SAEs. Immune responses to influenza vaccine antigens were similar for the two study vaccines, with robust HAI responses against influenza A strains, and relatively lower responses for influenza B strains.ConclusionSeasonal inactivated influenza vaccines were well tolerated and immunogenic in pregnant women.- ClinicalTrials.gov identifier NCT00905125.
Synopsis: In this prospective clinical trial, we demonstrated that immunization with seasonal trivalent, inactivated influenza vaccine in the second and third trimester of pregnancy is immunogenic and safe. |
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| Keywords: | Influenza vaccine Pregnant women Maternal immunization |
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