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 ™). (LAIV Immuno)
|ClinicalTrials.gov Identifier: NCT02143882|
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Live Attenuated Influenza Vaccine||Drug: Fluenz||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 ™).|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||March 31, 2017|
|Actual Study Completion Date :||March 31, 2017|
All children will receive LAIV, currently available as the marketed product Fluenz
Live attenuated influenza vaccine
- Immune responses to LAIV [ Time Frame: three subsequent years, all children ]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 .
- Incidence of influenza [ Time Frame: all children, three subsequent years ]To document the incidence of laboratory confirmed influenza and other respiratory viruses in the naïve and Pandemrix™ primed children over the three seasons.
- safety and tolerability of LAIV [ Time Frame: all children, three years of participation ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143882
|Gloucestershire, United Kingdom|
|Hertfordshire, United Kingdom|
|Principal Investigator:||Elizabeth Miller, MD||Public Health England|