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      Patient reported outcome data following influenza A (H1N1p) vaccination in the 2009–2010 season: web-based and telephone evaluation

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          There has been worldwide interest in the safety of the pandemic influenza A (H1N1p) vaccines, although limited data are available from the vaccine recipients’ perspective. This evaluation was designed to collect data from people who had received an influenza vaccination during the 2009–2010 season using a web-based data collection tool supplemented by telephone reporting ( PROBE).


          People scheduled to receive the influenza A (H1N1p) or seasonal influenza vaccines were recruited through media advertising and campaigns throughout the West of Scotland. Vaccine recipients participated in the evaluation by answering demographic and side effect questions using PROBE methodology on the day of the immunization, after 3 days, 8 days, 6 weeks, 12 weeks, and 26 weeks.


          A total of 1103 vaccine recipients including 134 young children (0–4 years) participated in the evaluation; 694 (63%) received H1N1p vaccine only, 135 (12%) seasonal vaccine only, 224 (20%) both H1N1p and seasonal vaccines, and 50 (5%) received H1N1p or seasonal vaccine with a non-influenza vaccine (eg, travel or pneumococcal). Overall, 42% of recipients reported experiencing a side effect after their baseline vaccination; the most commonly reported were general and arm side effects (>20%). Injection site discomfort/pain and flu-like symptoms were reported by 57% and 24% of recipients, respectively. A significantly higher proportion of the 960 H1N1p vaccine recipients experienced a side effect (44% vs 27%, P < 0.001) or injection site discomfort/pain (61% vs 26%, P < 0.001) than those receiving seasonal influenza vaccines. Female sex and H1N1p vaccination were associated with a significantly higher risk of injection site discomfort/pain, whereas the 70+ age group was associated with a significantly lower risk. H1N1p vaccine was well tolerated by children under 5 years with side effects reported at a similar frequency to that found in the total population.


          Safety and tolerability data from influenza vaccine recipients including young children (via parents/carers) can be effectively collected using an online questionnaire with a telephone option ( PROBE). The influenza A (H1N1p) vaccine was well tolerated, but was associated with more local short-term reactions than the seasonal influenza vaccine.

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          A clinical trial of a whole-virus H5N1 vaccine derived from cell culture.

          Widespread infections of avian species with avian influenza H5N1 virus and its limited spread to humans suggest that the virus has the potential to cause a human influenza pandemic. An urgent need exists for an H5N1 vaccine that is effective against divergent strains of H5N1 virus. In a randomized, dose-escalation, phase 1 and 2 study involving six subgroups, we investigated the safety of an H5N1 whole-virus vaccine produced on Vero cell cultures and determined its ability to induce antibodies capable of neutralizing various H5N1 strains. In two visits 21 days apart, 275 volunteers between the ages of 18 and 45 years received two doses of vaccine that each contained 3.75 microg, 7.5 microg, 15 microg, or 30 microg of hemagglutinin antigen with alum adjuvant or 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant. Serologic analysis was performed at baseline and on days 21 and 42. The vaccine induced a neutralizing immune response not only against the clade 1 (A/Vietnam/1203/2004) virus strain but also against the clade 2 and 3 strains. The use of adjuvants did not improve the antibody response. Maximum responses to the vaccine strain were obtained with formulations containing 7.5 microg and 15 microg of hemagglutinin antigen without adjuvant. Mild pain at the injection site (in 9 to 27% of subjects) and headache (in 6 to 31% of subjects) were the most common adverse events identified for all vaccine formulations. A two-dose vaccine regimen of either 7.5 microg or 15 microg of hemagglutinin antigen without adjuvant induced neutralizing antibodies against diverse H5N1 virus strains in a high percentage of subjects, suggesting that this may be a useful H5N1 vaccine. (ClinicalTrials.gov number, NCT00349141.) 2008 Massachusetts Medical Society
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            Immunogenicity and safety in adults of one dose of influenza A H1N1v 2009 vaccine formulated with and without AS03A-adjuvant: preliminary report of an observer-blind, randomised trial.

            Governments and public health officials are preparing vaccination campaigns against the 2009 influenza A H1N1v pandemic strain. We evaluated two inactivated split-virion A/California/7/2009 H1N1v pandemic vaccines formulated with/without AS03(A), an oil-in-water emulsion adjuvant system containing tocopherol. This ongoing observer-blind study randomised 130 healthy adults aged 18-60 years to receive either AS03(A)-adjuvanted H1N1 vaccine containing 5.25 microg haemagglutinin (HA) (N=64) or non-adjuvanted H1N1 vaccine containing 21 microg HA (N=66) on Days 0 and 21. We performed a first analysis of reactogenicity and serum haemagglutination-inhibition (HI) antibody responses, 21 days after dose 1. Before vaccination, 12.5% in the AS03(A)-adjuvanted group and 13.1% in the non-adjuvanted group had vaccine-homologous HI titres >or=1:40. Immune responses were robust; HI seroconversion rates were 98.2% and 95.1% and HI seroprotection rates were 98.2% and 98.4%, respectively in the AS03(A) and non-adjuvanted groups. The vaccines were well tolerated with similar adverse event profiles. Solicited injection site and general symptoms were reported more frequently for AS03(A)-adjuvanted vaccine but these were transient and mainly mild to moderate in intensity. Based on accepted immunological surrogates, these preliminary data suggest that one dose of either AS03(A)-adjuvanted H1N1v vaccine at a reduced HA dose or non-adjuvanted H1N1v vaccine at a fourfold higher dose is sufficient to immunise healthy adults. The strong immune response is consistent with prevalent immunological priming but as this and the ability to mount immune response after vaccination may be modulated by age, further investigations in children and in the elderly as well as on the persistence of the immune response are warranted. Copyright (c) 2009. Published by Elsevier Ltd.
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              Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial.

              With the ongoing 2009 pandemic of influenza A H1N1, development of pandemic influenza vaccines has generated much interest. We investigated the safety and immunogenicity of a whole-virion, inactivated, adjuvanted pandemic H1N1 vaccine in adult and elderly volunteers, given without or simultaneously with the 2009-10 seasonal trivalent influenza vaccine. This prospective, randomised study was undertaken in two centres in Hungary. 355 participants, including 203 adults (18-60 years) and 152 elderly people (>60 years), were assigned by stratified randomisation to either 0.5 mL of the pandemic vaccine (Fluval P, a monovalent vaccine with 6 microg haemagglutinin per 0.5 mL content and aluminium phosphate gel adjuvant; n=178) or 0.5 mL of the pandemic vaccine and 0.5 mL of the seasonal trivalent vaccine (Fluval AB, a trivalent inactivated whole-virion influenza vaccine; n=177). All vaccinations were done by specific study personnel, who did not take part in the assessment of safety or immunogenicity. Co-primary objectives were safety and immunogenicity by haemagglutinin inhibition testing. All analyses were done according to a pre-established analysis plan. This study is registered with ClinicalTrials.gov, number NCT01010893. Two participants receiving the pandemic vaccine only (group 1) and one receiving pandemic and seasonal vaccines (group 2) were lost to follow-up. Participants in both groups developed antibody responses against the pandemic influenza A H1N1 virus (group 1: seroconversion for adults 74.3%, 95% CI 64-6-82.4 and for elderly people 61.3%, 49.1-72.4; group 2: 76.8%, 67.2-84.7 and 81.8%, 71.4-89.7, respectively). Single doses of 6 microg fulfilled European Union and US licensing criteria for interpandemic and pandemic influenza vaccines. Simultaneously, participants in group 2 developed the immune responses needed for licensing for all three seasonal strains in the seasonal vaccine for the 2009-10 season. All adverse events were rare, mild, and transient; the most frequent were pain at injection site (eight cases in group 1 vs 18 in group 2) and fatigue for 1-2 days after vaccination (three vs five cases). The present pandemic vaccine is safe and immunogenic in healthy adult and elderly patients, and needs low doses and only one injection to trigger immune responses to comply with licensing criteria. It can be safely co-administered with the 2009-10 seasonal influenza vaccine. Omninvest, Hungary. Copyright 2010 Elsevier Ltd. All rights reserved.

                Author and article information

                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                21 October 2011
                : 7
                : 409-420
                [1 ]Patients Direct, 3 Todd Campus, Glasgow, UK
                [2 ]Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
                Author notes
                Correspondence: Alan G Wade, Patients Direct, 3 Todd Campus, Glasgow, UK, Tel +44 141 946 8618, Fax +44 141 946 1324, Email alan@ 123456patientsdirect.org
                © 2011 Wade et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Original Research


                influenza, patient reported outcomes, h1n1, side effects, vaccination, safety


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