Prevention of Influenza infections MedDRA version: 12.0 Level: LLT Classification code 10059429 Term: Influenza immunisation
Conditions
Interventions
Trade Name: Fluarix
Product Name: Fluarix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/California/7/2009 (H1N1) derived strain used NYMC X-181
Concentration unit: µg/ml microgr
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participants must have completed the original NIHR funded study (NCT00980850)(1) comparing Celvapan with Pandemrix at one of the study sites participating in this follow-on study. All participants must satisfy all the following criteria to be eligible for the study: • A parent/legal guardian has given written informed consent after the nature of the study has been explained; • Willingness to complete visit 1. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Participant(s) in original study (NCT00980850)(1) who had a suspected unexpected serious adverse reaction (SUSAR). • History of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza vaccine component • Current egg allergy • Known or suspected impairment/alteration of the immune system • Disorders of coagulation • Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrolment • Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrolment • Previous receipt of, or intent to immunize with, any other seasonal influenza vaccine(s) throughout the 2010/2011 influenza season. • Participation in another clinical trial of an investigational medical product • Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g. cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g. Trisomy 21) or will affect the ability to accurately describe adverse events (e.g. children over 5 years of age but with severe learning difficulties) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Reactogenicity of trivalent seasonal influenza vaccine To compare the percentage of children experiencing fever, local reactions and non-febrile systemic reactions within the 7 days following one dose of a non-adjuvanted seasonal trivalent influenza vaccine 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix. 2. Immunogenicity of trivalent seasonal influenza vaccine To compare the percentage of children who seroconvert and have a post-vaccination MN titre =1:40 or HI titre =1:32 (H1N1 strain) or who were seropositive at pre-vaccination and have a 4- fold increase in titre, following one dose of a non-adjuvanted seasonal trivalent influenza vaccine, 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix. 3. Persistence of microneutralising antibody titres against H1N1v To compare the percentage of children with microneutralisation (MN) titres = 1:40, 11-15 months after receiving a two-dose immunis;Secondary Objective: 1. Persistence of antibody titres to H1N1v To compare the percentage of children with HI titre = 1: 32 and the geometric mean HI and MN titres 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix. 2. Long-term safety monitoring of Pandemrix and Celvapan Specific adverse events (influenza-like illnesses (ILI) , hospitalisations, febrile convulsions, autoimmunity and adverse events of special interest (AESI’s )) will be assessed in all participants. 3. To store serum For future testing of the immunogenicity of trivalent seasonal influenza vaccine for H3N2 and B strains, 11-15 months after receiving a two-dose immunisation regimen of either Celvapan or Pandemrix. Also, should a drifted H1N1 strain emerge next season, this would provide a valuable source of sera to assess cross protection. 4. T cell Responses To study the T cell responses to internal influenza antigens and haemagglutinin (pandemic H1) 5. Genetics | — |
Countries
United Kingdom
Outcome results
None listed