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rug Saf. 2017 Oct 12. doi: 10.1007/s40264-017-0605-3. [Epub ahead of print] Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.
Nigwekar PV1, Kumar A1, Padbidri VV2, Choudhury A3, Chaudhari AB4, Kulkarni PS5.
Author information
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).
PMID: 29027148 DOI: 10.1007/s40264-017-0605-3
Nigwekar PV1, Kumar A1, Padbidri VV2, Choudhury A3, Chaudhari AB4, Kulkarni PS5.
Author information
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).
PMID: 29027148 DOI: 10.1007/s40264-017-0605-3