PMID- 26643931
OWN - NLM
STAT- MEDLINE
DCOM- 20161012
LR  - 20171023
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 34
IP  - 2
DP  - 2016 Jan 4
TI  - Safety and tolerability of a cell culture derived trivalent subunit inactivated 
      influenza vaccine administered to healthy children and adolescents: A Phase III, 
      randomized, multicenter, observer-blind study.
PG  - 230-236
LID - S0264-410X(15)01682-5 [pii]
LID - 10.1016/j.vaccine.2015.11.040 [doi]
AB  - BACKGROUND: Cell culture-derived inactivated influenza vaccines (TIVc) are 
      necessary for scale and predictability of production to meet global demand. This 
      study compared the safety and tolerability of TIVc with an egg-derived trivalent 
      influenza vaccine (TIVf) in 4-17 yearolds. METHODS: A Phase 3 observer blind, 
      multicenter study enrolled 2055 healthy participants randomized 2:1 to receive 
      either TIVc or TIVf, respectively (1372 TIVc and 683 TIVf evaluable subjects). 
      Participants received one dose each on Days 1 and 28 (4-8 year-olds not 
      previously vaccinated [NPV]) or one dose on Day 1 (4-8 and 9-17 yearolds 
      previously vaccinated [PV]). Solicited adverse events (AEs) occurring within 7 
      days after each vaccination were assessed; participants were followed up for 6 
      months after their last dose for safety. RESULTS: Most solicited and unsolicited 
      AEs were mild to moderate with <1% in the severe category. No withdrawals due to 
      AEs, deaths or vaccine-related SAEs were reported. TIVc and TIVf were similar in 
      percentages of participants reporting solicited reactions in 4-8 years NPV group 
      after the 1st dose: local reactions, TIVc: 48%, TIVf: 43%; systemic reactions, 
      TIVc: 34%, TIVf: 32%; percentages were lower following the 2nd dose in TIVc; 
      local reactions: TIVc: 40%; TIVf: 43%; systemic reactions: TIVc: 21%; TIVf: 22%. 
      In 4-17 years PV group, solicited reactions were lower following TIVf, local 
      reactions: TIVc: 53%; TIVf: 43%; systemic reactions: TIVc: 37%, TIVf: 30%. 
      Injection-site pain was the most common solicited reaction, and was similar 
      following TIVc and TIVf in 4-8 yearolds (TIVc: 56%; TIVf: 55%), and lower 
      following TIVf in 9-17 years group (TIVc: 52%; TIVf: 42%). Reporting of 
      unsolicited AEs was similar for TIVc and TIVf across the two age groups. 
      CONCLUSION: TIVc was well tolerated and had a safety and reactogenicity profile 
      similar to that of TIVf in healthy 4-17 yearolds (NCT01857206).
CI  - Copyright (c) 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Nolan, Terry
AU  - Nolan T
AD  - The Melbourne School of Population and Global Health and Murdoch Childrens 
      Research Institute, University of Melbourne, Melbourne, Australia.. Electronic 
      address: t.nolan@unimelb.edu.au.
FAU - Chotpitayasunondh, Tawee
AU  - Chotpitayasunondh T
AD  - Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
FAU - Capeding, Maria Rosario
AU  - Capeding MR
AD  - Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
FAU - Carson, Simon
AU  - Carson S
AD  - Southern Clinical Trials Ltd, Beckenham, Christchurch, New Zealand.
FAU - Senders, Shelly David
AU  - Senders SD
AD  - Senders Pediatrics, Cleveland, OH, USA.
FAU - Jaehnig, Peter
AU  - Jaehnig P
AD  - Novartis Vaccines and Diagnostics GmbH, Marburg, Germany.
FAU - de Rooij, Richard
AU  - de Rooij R
AD  - Novartis Pharma BV, Amsterdam, The Netherlands.
FAU - Chandra, Richa
AU  - Chandra R
AD  - Novartis Vaccines and Diagnostics Inc., Cambridge, MA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01857206
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151129
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Vaccines, Subunit)
RN  - 0 (Vaccines, Synthetic)
SB  - IM
MH  - Adolescent
MH  - Cell Culture Techniques
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/pathology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Influenza Vaccines/*administration & dosage/*adverse effects
MH  - Male
MH  - Single-Blind Method
MH  - Technology, Pharmaceutical
MH  - Vaccines, Inactivated/administration & dosage/immunology
MH  - Vaccines, Subunit/administration & dosage/immunology
MH  - Vaccines, Synthetic/administration & dosage/immunology
OTO - NOTNLM
OT  - Cell-culture
OT  - Children
OT  - Influenza
OT  - Safety
EDAT- 2015/12/09 06:00
MHDA- 2016/10/13 06:00
CRDT- 2015/12/09 06:00
PHST- 2015/02/25 00:00 [received]
PHST- 2015/09/08 00:00 [revised]
PHST- 2015/11/15 00:00 [accepted]
PHST- 2015/12/09 06:00 [entrez]
PHST- 2015/12/09 06:00 [pubmed]
PHST- 2016/10/13 06:00 [medline]
AID - S0264-410X(15)01682-5 [pii]
AID - 10.1016/j.vaccine.2015.11.040 [doi]
PST - ppublish
SO  - Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 
      Nov 29.