A Phase 4 interventional study of Fluenz in Live Attenuated Influenza Vaccine, sponsored by Public Health England. Completed at 2 sites in United Kingdom. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-16.
Sponsored by Public Health England · Phase 4, Interventional, and Treatment
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 300 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Public Health England is the lead sponsor of 36 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Parent/legal guardian gives written informed consent for participation of their child in the study.
Exclusion Criteria:
From Fluenz Summary of Product Characteristics (SPC):
Study specific exclusions:
From the SPC:
Administration of influenza antiviral agents within two weeks of vaccination may affect the response of the vaccine.
Because of this information in the SPC, should any child be given these medications the administration of LAIV would be delayed as specified.
Study specific:
All children will receive LAIV, currently available as the marketed product Fluenz
Drug: Fluenz
Live attenuated influenza vaccine
Immune responses to LAIV
To compare the immune response to homologous and heterologous strains before and after to annual doses of LAIV over three consecutive years in children aged 49(+364days) years at enrollment in naïve children vs those in previous receipt of the AS03B adjuvanted pandemic influenza vaccine to homologous vaccine strains .
Time frame: three subsequent years, all children
Incidence of influenza
To document the incidence of laboratory confirmed influenza and other respiratory viruses in the naïve and Pandemrix™ primed children over the three seasons.
Time frame: all children, three subsequent years
safety and tolerability of LAIV
To compare the safety and tolerability of annual doses of LAIV in naïve compared to Panemrix™ vaccinated children in terms of local and systemic reactions following vaccination as recorded in a health diary for the week following vaccination as well as any serious adverse events identified throughout the study period.
Time frame: all children, three years of participation
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Public Health England