Safety of Russian-backbone seasonal trivalent, live-attenuated influenza vaccine in a phase II randomized placebo-controlled clinical trial among children in urban Bangladesh

Highlights • Live-attenuated influenza vaccines could benefit low-resource populations. • We conducted a phase II randomized clinical trial in urban Bangladeshi children. • We monitored participant safety, including wheezing illness, for 6 months. • Solicited reactions, wheezing, and related serious...

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Veröffentlicht in:	Vaccine 2015-06, Vol.33 (29), p.3415-3421
Hauptverfasser:	Ortiz, Justin R, Goswami, Doli, Lewis, Kristen D.C, Sharmeen, Amina Tahia, Ahmed, Moshtaq, Rahman, Mustafizur, Rahman, Mohammed Z, Feser, Jodi, Neuzil, Kathleen M, Brooks, W. Abdullah
Format:	Artikel
Sprache:	eng
Schlagworte:	Adverse events Age Allergy and Immunology Asthma Backbone Bangladesh Child, Preschool Children Clinical trial Clinical trials Cysts Developing countries Double-Blind Method Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - pathology Female Fever Field study Gastroenteritis Hospitalization Humans Illnesses Immunization Infections Influenza Influenza Vaccines - administration & dosage Influenza Vaccines - adverse effects Influenza, Human - prevention & control LDCs Live attenuated influenza vaccine Male Medical treatment Overdose Pain Paracetamol Placebos Placebos - administration & dosage Respiratory Sounds Safety Statistical analysis Ulcers Vaccines Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - adverse effects Wheezing
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Beschreibung
Zusammenfassung:	Highlights • Live-attenuated influenza vaccines could benefit low-resource populations. • We conducted a phase II randomized clinical trial in urban Bangladeshi children. • We monitored participant safety, including wheezing illness, for 6 months. • Solicited reactions, wheezing, and related serious adverse events were balanced. • Further study of vaccine safety and performance in a larger cohort is warranted.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2015.04.048