PMID- 29027148
OWN - NLM
STAT- MEDLINE
DCOM- 20181003
LR  - 20181004
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 41
IP  - 2
DP  - 2018 Feb
TI  - Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine 
      in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.
PG  - 171-177
LID - 10.1007/s40264-017-0605-3 [doi]
AB  - INTRODUCTION AND AIM: A trivalent live attenuated influenza vaccine
      (Nasovac-S((R))) 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).
FAU - Nigwekar, Prashant V
AU  - Nigwekar PV
AD  - Pravara Institute of Medical Sciences, Loni, India.
FAU - Kumar, Anuj
AU  - Kumar A
AD  - Pravara Institute of Medical Sciences, Loni, India.
FAU - Padbidri, Vikram V
AU  - Padbidri VV
AD  - Jehangir Hospital, Pune, India.
FAU - Choudhury, Amlan
AU  - Choudhury A
AD  - KPC Medical College, Kolkata, India.
FAU - Chaudhari, Amol B
AU  - Chaudhari AB
AD  - Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India.
      amol.chaudhari@seruminstitute.com.
FAU - Kulkarni, Prasad S
AU  - Kulkarni PS
AD  - Serum Institute of India Pvt. Ltd, 212/2, Hadapsar, Pune, India.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Administration, Intranasal/methods
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/immunology
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - India
MH  - Influenza Vaccines/*adverse effects
MH  - Influenza, Human/prevention & control
MH  - Male
MH  - Middle Aged
MH  - Russia
MH  - Seasons
MH  - Vaccination/methods
MH  - Vaccines, Attenuated/*adverse effects
MH  - Vaccines, Inactivated/*adverse effects
MH  - Young Adult
EDAT- 2017/10/14 06:00
MHDA- 2018/10/04 06:00
CRDT- 2017/10/14 06:00
PHST- 2017/10/14 06:00 [pubmed]
PHST- 2018/10/04 06:00 [medline]
PHST- 2017/10/14 06:00 [entrez]
AID - 10.1007/s40264-017-0605-3 [doi]
AID - 10.1007/s40264-017-0605-3 [pii]
PST - ppublish
SO  - Drug Saf. 2018 Feb;41(2):171-177. doi: 10.1007/s40264-017-0605-3.