PMID- 23388195
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130208
LR  - 20211021
IS  - 2044-6055 (Print)
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 3
IP  - 2
DP  - 2013
TI  - Safety of AS03-adjuvanted split-virion H1N1 (2009) pandemic influenza vaccine: a 
      prospective cohort study.
LID - 10.1136/bmjopen-2012-001912 [doi]
LID - e001912
AB  - OBJECTIVES: To assess the safety of an AS03-adjuvanted split virion H1N1 (2009) 
      vaccine (Pandemrix) in persons vaccinated during the national pandemic influenza 
      vaccination campaign in the UK. DESIGN: Prospective, cohort, observational, 
      postauthorisation safety study. SETTING: 87 general practices forming part of the 
      Medical Research Council General Practice Research Framework and widely 
      distributed throughout England. PARTICIPANTS: A cohort of 9143 individuals aged 7 
      months to 97 years who received at least one dose of the AS03-adjuvanted H1N1 
      pandemic vaccine during the national pandemic influenza vaccination campaign in 
      the UK was enrolled. 94% completed the 6-month follow-up. Exclusion criteria were 
      previous vaccination with other H1N1 pandemic vaccine and any child in care. 
      PRIMARY AND SECONDARY OUTCOME MEASURES: Medically attended adverse events (MAEs) 
      occurring within 31 days after any dose, serious adverse events (SAEs) and 
      adverse events of special interest (AESIs) following vaccination were collected 
      for all participants. Solicited adverse events (AEs) were assessed in a subset of 
      participants. RESULTS: MAEs were reported in 1219 participants and SAEs in 113 
      participants during the 31-day postvaccination period. The most frequently 
      reported MAEs and SAEs were consistent with events expected to be reported during 
      the winter season in this population: lower respiratory tract infections, asthma 
      and pneumonia. The most commonly reported solicited AEs were irritability in 
      young children aged <5 years (61.8%), muscle aches in children aged 5-17 years 
      (61.9%) and adults (46.9%). 18 AESIs, experienced by 14 patients, met the 
      criteria to be considered for the observed-to-expected analyses. AESIs above the 
      expected number were neuritis (1 case within 31 days) and convulsions (8 cases 
      within 181 days). There were 41 deaths during the 181-day period after 
      vaccination, fewer than expected. CONCLUSIONS: Results indicate that the 
      AS03-adjuvanted H1N1 pandemic vaccine showed a clinically acceptable 
      reactogenicity and safety profile in all age and risk groups studied. TRIAL 
      REGISTRATION: ClinicalTrials.gov, NCT00996853.
FAU - Nazareth, Irwin
AU  - Nazareth I
AD  - Department of Primary Care & Population Health, University College London Medical 
      School, London, UK.
FAU - Tavares, Fernanda
AU  - Tavares F
FAU - Rosillon, Dominique
AU  - Rosillon D
FAU - Haguinet, Francois
AU  - Haguinet F
FAU - Bauchau, Vincent
AU  - Bauchau V
LA  - eng
SI  - ClinicalTrials.gov/NCT00996853
PT  - Journal Article
DEP - 20130205
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
EIN - BMJ Open. 2013 Feb 19;3(2):null. PMID: 23427201
PMC - PMC3586178
EDAT- 2013/02/08 06:00
MHDA- 2013/02/08 06:01
PMCR- 2013/02/05
CRDT- 2013/02/08 06:00
PHST- 2013/02/08 06:00 [entrez]
PHST- 2013/02/08 06:00 [pubmed]
PHST- 2013/02/08 06:01 [medline]
PHST- 2013/02/05 00:00 [pmc-release]
AID - bmjopen-2012-001912 [pii]
AID - 10.1136/bmjopen-2012-001912 [doi]
PST - epublish
SO  - BMJ Open. 2013 Feb 5;3(2):e001912. doi: 10.1136/bmjopen-2012-001912. Print 2013.