Live Attenuated Influenza Vaccine Clinical Trial
Official title:
A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™).A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™).
The Department of Health has recently announced the implementation of annual vaccination for all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is delivered as a nasal spray. This study seeks primarily to measure antibody responses to the LAIV vaccination over three subsequent years and will involve six blood samples, six dried blood spots (taken from the end of the blood sample needle) and six oral fluid samples - before and three weeks after each vaccination each year. These samples will allow us to assess how the immune system responds to the vaccinations in terms of the antibodies that are present.
The Department of Health has recently announced the implementation of annual vaccination for
all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is
delivered as a nasal spray. The programme will begin in the influenza season, from September
2013, with children aged 24 years of age, and older children being included from the
influenza season of 2014. Therefore this study seeks primarily to measure antibody responses
to the LAIV vaccination over three subsequent years and will involve six blood samples, six
dried blood spots (taken from the end of the blood sample needle) and six oral fluid samples
- before and three weeks after each vaccination each year. These samples will allow us to
assess how the immune system responds to the vaccinations in terms of the antibodies that are
present.
The study will specifically recruit children in previous receipt of Pandemrix, a pandemic
influenza vaccine, and those naïve to pandemic influenza vaccination, which will allow the
comparison of responses to LAIV between these groups.
The sample size required to answer the primary objective of the study is 200 evaluable
children per group. As the study will be conducted over three years the recruitment target
will be 500 children across the two groups to allow for the expected attrition of numbers
over time.
The investigators will also be assessing how well the vaccines are tolerated and each
participant will therefore be asked to complete a health diary for the week following
vaccination. They will be asked to record any symptoms, which the investigators will elicit
in line with the information in the Summary of Product Characteristics (SPC) as well as any
illnesses or visits to their GP or hospital.
;