PMID- 21396903
OWN - NLM
STAT- MEDLINE
DCOM- 20110728
LR  - 20131121
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 29
IP  - 18
DP  - 2011 Apr 18
TI  - Safety of MF-59 adjuvanted vaccine for pandemic influenza: results of the 
      vaccination campaign in an Italian health district.
PG  - 3443-8
LID - 10.1016/j.vaccine.2011.02.068 [doi]
AB  - BACKGROUND: The occurrence of pandemic H1N1 influenza in 2009 led health 
      authorities to promptly start massive vaccination campaigns. Due to the need of 
      shortening time for development and approval, the pandemic vaccine was prepared 
      by mock-up strategy, and limited safety data were available upon starting vaccine 
      administration. AIMS: To determine the frequencies and clinical features of 
      adverse events (AEs) observed in a population of subjects of an Italian health 
      district receiving pandemic vaccination. The risk for the development of at least 
      one AE was calculated for patients receiving H1N1 vaccine only or H1N1+seasonal 
      vaccine. METHODS: This prospective observational study was performed on the 
      population of La Spezia Health District scheduled to receive pandemic 
      MF-59-adjuvanted H1N1 vaccine. Subjects were enrolled at the time of vaccine 
      administration and followed up at least for 6 months. The study population was 
      stratified in two subgroups defined by administration of H1N1 vaccine only or 
      H1N1+seasonal vaccine. AEs were recorded during the first hour following vaccine 
      administration (early AEs) and through periodic telephonic interviews (delayed 
      AEs). RESULTS: An overall number of 506 subjects receiving pandemic vaccine were 
      enrolled (H1N1 only: 131 subjects; H1N1+seasonal: 375 subjects). 233 AEs occurred 
      throughout the study period. Among them, 211 were resolved, while 22 were ongoing 
      at the last available follow-up. Adjusted incidence rate ratio (IRR) for the 
      development of at least one AE was 1.14 (0.77-1.69) for H1N1 only group vs 
      H1N1+seasonal group. Patients with a nervous system AE were more frequent in the 
      H1N1+seasonal group (adjusted IRR: 2.33; 95%CI: 1.04-5.23). Only two cases of 
      ischemic stroke, both in the H1N1+seasonal vaccine group, occurred in patients 
      with cardiovascular risk factors, were classified as serious AEs. CONCLUSIONS: In 
      the present study, the MF59-adjuvanted H1N1 vaccine was generally well tolerated. 
      AEs were usually transient and mild to moderate in intensity. Our findings 
      support the validity of mock-up strategy for rapid development of a safe vaccine 
      in the emergency of a pandemic influenza.
CI  - Copyright (c) 2011 Elsevier Ltd. All rights reserved.
FAU - Cristiani, Cristina
AU  - Cristiani C
AD  - Pharmaceutical Department, Health District of La Spezia, La Spezia, Italy.
FAU - Tuccori, Marco
AU  - Tuccori M
FAU - Pepe, Pasquale
AU  - Pepe P
FAU - Sarteschi, Alessandro
AU  - Sarteschi A
FAU - Maddalo, Francesco
AU  - Maddalo F
FAU - Simonini, Gianmarco
AU  - Simonini G
FAU - Michi, Paola
AU  - Michi P
FAU - Consigli, Veronica
AU  - Consigli V
FAU - Fornai, Matteo
AU  - Fornai M
FAU - Antonioli, Luca
AU  - Antonioli L
FAU - Blandizzi, Corrado
AU  - Blandizzi C
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110309
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
RN  - 0 (MF59 oil emulsion)
RN  - 0 (Polysorbates)
RN  - 0 (focetria)
RN  - 7QWM220FJH (Squalene)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Arthralgia/chemically induced
MH  - Child
MH  - Child, Preschool
MH  - Fatigue/chemically induced
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Infant
MH  - Influenza A Virus, H1N1 Subtype/immunology
MH  - Influenza Vaccines/*adverse effects/immunology
MH  - Influenza, Human/prevention & control
MH  - Italy
MH  - Male
MH  - Middle Aged
MH  - Polysorbates/pharmacology
MH  - Pregnancy
MH  - Prospective Studies
MH  - Squalene/pharmacology
MH  - Vaccination
EDAT- 2011/03/15 06:00
MHDA- 2011/07/29 06:00
CRDT- 2011/03/15 06:00
PHST- 2010/12/01 00:00 [received]
PHST- 2011/02/15 00:00 [revised]
PHST- 2011/02/20 00:00 [accepted]
PHST- 2011/03/15 06:00 [entrez]
PHST- 2011/03/15 06:00 [pubmed]
PHST- 2011/07/29 06:00 [medline]
AID - S0264-410X(11)00303-3 [pii]
AID - 10.1016/j.vaccine.2011.02.068 [doi]
PST - ppublish
SO  - Vaccine. 2011 Apr 18;29(18):3443-8. doi: 10.1016/j.vaccine.2011.02.068. Epub 2011 
      Mar 9.