Dataset Information

The long-term immunogenicity of an inactivated split-virion 2009 pandemic influenza A H1N1 vaccine: Randomized, observer-masked, single-center clinical study.

ABSTRACT: The aim of this study is to investigate the long-term immunogenicity of inactivated split-virion 2009 pandemic influenza A H1N1 vaccine after a single immunization. We recruited 480 adults, aged 18-60 years, for a placebo-controlled, observer-masked, single-center clinical study. We randomly assigned subjects into four groups: 15??g, 30??g and 45??g of hemagglutinin (HA) dosage groups, and a placebo control group. Finally, 259 subjects completed the entire study. The rates of seroconversion and seroprotection and the geometric mean increase (GMI) fulfilled the criteria of the European Medicines Agency (EMEA) for influenza vaccine for 180 days after vaccination in all three dosage groups. However, the seroprotection rates of all dosage groups were below 70% at day 360 post vaccination, while the seroconversion rates and the GMI continued to meet the licensure criteria at this time point. In conclusion, a single dose of 15??g HA vaccine could induce a protective immune response persisting for at least six months in adults. This study could be beneficial for the future development of influenza vaccines conferring long-term immunity.

SUBMITTER: Yang Z

PROVIDER: S-EPMC3862378 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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The long-term immunogenicity of an inactivated split-virion 2009 pandemic influenza A H1N1 vaccine: Randomized, observer-masked, single-center clinical study.

Yang Zhongdong Z Wang Shilei S Li Wei W Li Changgui C Dong Jinrong J Li Fangjun F Wang Shuqiao S Chai Wenqing W Sun Bing B Chen Ze Z

Results in immunology 20121009

The aim of this study is to investigate the long-term immunogenicity of inactivated split-virion 2009 pandemic influenza A H1N1 vaccine after a single immunization. We recruited 480 adults, aged 18-60 years, for a placebo-controlled, observer-masked, single-center clinical study. We randomly assigned subjects into four groups: 15 μg, 30 μg and 45 μg of hemagglutinin (HA) dosage groups, and a placebo control group. Finally, 259 subjects completed the entire study. The rates of seroconversion and ...[more]

PMID: 24371582

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Project description:ObjectivesTo 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.DesignProspective, cohort, observational, postauthorisation safety study.Setting87 general practices forming part of the Medical Research Council General Practice Research Framework and widely distributed throughout England.ParticipantsA 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 measuresMedically 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.ResultsMAEs 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.ConclusionsResults indicate that the AS03-adjuvanted H1N1 pandemic vaccine showed a clinically acceptable reactogenicity and safety profile in all age and risk groups studied.Trial registrationClinicalTrials.gov, NCT00996853.

Dataset Information

The long-term immunogenicity of an inactivated split-virion 2009 pandemic influenza A H1N1 vaccine: Randomized, observer-masked, single-center clinical study.

Publications

The long-term immunogenicity of an inactivated split-virion 2009 pandemic influenza A H1N1 vaccine: Randomized, observer-masked, single-center clinical study.

Similar Datasets

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