Influenza Clinical Trial
Official title:
Open Label, Randomized, Parallel-Group, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 Vaccine and GlaxoSmithKline H1N1 Vaccine in Children 6 Months to 12 Years of Age
In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza
pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest
rates of disease are being seen in young children. In anticipation of an influenza pandemic
two vaccine manufacturers, Baxter and GlaxoSmithKline, have gained marketing authorization
approval from the European Medicines Agency (EMEA) for a pandemic strain vaccine under the
"mockup" dossier route based on limited clinical trial data for a candidate H5N1 vaccine.
This "mockup" dossier route for pandemic influenza vaccines allows the submission of a core
pandemic dossier during the interpandemic period, which results in the approval of a mockup
pandemic vaccine. This is followed by a fast track approval of the pandemic vaccine based on
the submission of the pandemic variation when the situation arises. The Baxter and
GlaxoSmithKline vaccines have now been modified to cover the novel influenza A H1N1 strain.
Given the high rates of swine flu disease in children, this age group is likely to
particularly benefit from immunization against this virus, however there are few data on the
use of these vaccines in a pediatric population. The proposed study therefore aims to assess
the immunogenicity, safety, and tolerability of these two H1N1 vaccines when administered as
two doses three weeks apart to children aged 6 months to 12 years of age.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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