Swine Flu (Novel Influenza A H1N1) Vaccine Study

The study will be an open label, randomised, parallel group, multicentre clinical trial conducted by a consortium of the leading paediatric vaccine research units in the United Kingdom. The study will recruit healthy children 6 months to 12 years of age. Children with previously laboratory confirmed infection with swine flu will be excluded, as will those that have received a treatment course of oseltamivir. Children with immune deficiencies and egg allergy will also be excluded.

The study will be conducted as a collaboration between the Health Protection Agency and the following study recruitment sites: Oxford Vaccine Group (OVG), Bristol Children's Vaccine Centre (BCVC), the Royal Devon and Exeter Hospital, St George's Vaccine Institute (SGVI) and the University of Southampton Wellcome Trust Clinical Research Facility (USWTCRF). Families in the area of these research sites will be notified of the study by methods including print and electronic media, posters and direct mail out via the child health computer departments. The study visits themselves will be conducted in locations such as hospital outpatients, GP surgeries, or schools. General practitioners will be informed of the study and all immunisations administered during the study, as will the relevant child health computer department.

Participants will be randomised on 1:1 basis to receive 2 doses of either of the H1N1 influenza vaccines being studied. These vaccines will be given 2-3 weeks apart and the blood tests will be taken at baseline and around 3 weeks after completion of the 2 dose immunisation course. If at the start of the trial there is clinical data or a recommendation from JCVI that supports the use of a half dose of either vaccine in children under 3 years of age, this will be used for this age group and the ethics committee will be informed of this change.

Participants' families will be given diary cards to record local and systemic reactions to the vaccines administered, as well as recording daily temperatures for the 7 days after receipt of the vaccines. They will be telephoned 5-7 days after each vaccination to determine if there have been any SAEs since vaccination and to remind them to mail their completed diary cards to the HPA. Participants' families will also receive a memory card on which to record any visits to a doctor or emergency department from the 8th day after vaccine administration to the next study visit and any adverse events recorded in the diary card that are ongoing after day 7.

There will be 4 groups of children in the study:

Group A1: Children aged 6 months to less than 3 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.

Group B1: Children aged 6 months to less than 3 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.

Group A2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the Baxter H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.

Group B2: Children aged greater than 3 years of age to 12 years of age will receive 2 doses of the GSK H1N1 vaccine, 2-3 weeks apart. A blood sample will be taken at baseline and around 3 weeks after the second vaccine dose.