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

Prashant V. Nigwekar, Anuj Kumar, Vikram V. Padbidri, Amlan Choudhury, Amol B. Chaudhari () and Prasad S. Kulkarni
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Prashant V. Nigwekar: Pravara Institute of Medical Sciences
Anuj Kumar: Pravara Institute of Medical Sciences
Vikram V. Padbidri: Jehangir Hospital
Amlan Choudhury: KPC Medical College
Amol B. Chaudhari: Serum Institute of India Pvt. Ltd
Prasad S. Kulkarni: Serum Institute of India Pvt. Ltd

Drug Safety, 2018, vol. 41, issue 2, No 4, 177 pages

Abstract: Abstract 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).

Date: 2018
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DOI: 10.1007/s40264-017-0605-3

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