tetano
Editor, Senior Moderator
rug Saf. 2017 Oct 12. doi: 10.1007/s40264-017-0605-3. [Epub ahead of print] [h=1]Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.[/h] Nigwekar PV[SUP]1[/SUP], Kumar A[SUP]1[/SUP], Padbidri VV[SUP]2[/SUP], Choudhury A[SUP]3[/SUP], Chaudhari AB[SUP]4[/SUP], Kulkarni PS[SUP]5[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION AND AIM:[/h] A trivalent live attenuated influenza vaccine (Nasovac-S[SUP]?[/SUP]) was developed and licensed in India. A phase 4 study was conducted to assess safety.
[h=4]METHODOLOGY:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] The data from the study adds to the existing safety database of Nasovac-S.
[h=4]REGISTRY:[/h] Clinical Trials Registry of India (CTRI/2015/08/006074).
PMID: 29027148 DOI: 10.1007/s40264-017-0605-3
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION AND AIM:[/h] A trivalent live attenuated influenza vaccine (Nasovac-S[SUP]?[/SUP]) was developed and licensed in India. A phase 4 study was conducted to assess safety.
[h=4]METHODOLOGY:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSIONS:[/h] The data from the study adds to the existing safety database of Nasovac-S.
[h=4]REGISTRY:[/h] Clinical Trials Registry of India (CTRI/2015/08/006074).
PMID: 29027148 DOI: 10.1007/s40264-017-0605-3