Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.

Autor: Nigwekar PV; Pravara Institute of Medical Sciences, Loni, India., Kumar A; Pravara Institute of Medical Sciences, Loni, India., Padbidri VV; Jehangir Hospital, Pune, India., Choudhury A; KPC Medical College, Kolkata, India., Chaudhari AB; Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India. amol.chaudhari@seruminstitute.com., Kulkarni PS; Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India.
Jazyk: angličtina
Zdroj: Drug safety [Drug Saf] 2018 Feb; Vol. 41 (2), pp. 171-177.
DOI: 10.1007/s40264-017-0605-3
Abstrakt: Introduction and Aim: A trivalent live attenuated influenza vaccine (Nasovac-S ® ) was developed and licensed in India. A phase 4 study was conducted to assess safety.
Methodology: This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries.
Results: Among 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18-49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine.
Conclusions: The data from the study adds to the existing safety database of Nasovac-S.
Registry: Clinical Trials Registry of India (CTRI/2015/08/006074).
Databáze: MEDLINE
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