Infectious Dis. Medical News about H1N1 vaccine clinical trials; adults; adverse events

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H1N1 Vaccine Clinical Trials in Adults Free of Serious Adverse Events. Efficacy Data From Initial Doses Expected in September
American Family Physician, 08/28/09

Mitchell D – No serious adverse events have been reported during the first two weeks of clinical trials involving vaccine against the novel influenza A (H1N1) virus. Although there have been incidences of swelling and pain at the injection site, which is seen with almost every vaccine, there have been no serious adverse events. Clinical trials with adults and the elderly started Aug. 7 and are examining whether the vaccine should contain 15 mg or 30 mg of antigen, as well as whether one or two doses would be needed to provide adequate protection. The clinical trials also will determine whether the new vaccine should be given before, after or at the same time as seasonal flu vaccine. Data derived from participants who have received the first dose is expected to be available in mid–September, with second–dose data available in mid–October. On Aug. 19 and 20, similar trials began in children ages 6 months to 17 years. First–dose data from those trials should be available by late September, with second–dose data expected in late October. Trials involving pregnant women are scheduled to begin in early September, and trials involving the use of adjuvants are expected to start in mid– or late September.

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