Protection against influenza in healthy children MedDRA version: 14.1 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: PT Classification code 10059429 Term: Influenza immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: FLUENZ? nasal spray suspension
Product Name: Fluenz
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI
Sponsors
Public Health England
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Parent/legal guardian gives written informed consent for participation of their child in the study. • Male or female aged 4 years (+364 days) to 8 years (+364 days) on the day of consent. • Documented prior receipt of Pandemrix, or no evidence in the medical notes of never having had pandemic influenza vaccine. Are the trial subjects under 18? yes Number of subjects for this age range: 500 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: *Absolute exclusion criteria - The participant may not enter the study if ANY of the following apply: From Fluenz Summary of Product Characterstics (SPC): • Hypersensitivity to the active substances, to any of the excipients (e.g. gelatin; see appendix 1), to gentamicin (a possible trace residue), to eggs or to egg proteins (e.g. ovalbumin). • Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. FLUENZ is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency. • Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection. Study specific exclusions: • Any contraindication to vaccination as specified in the “Green Book”- Immunisation against Infectious Disease, HMSO. • known bleeding diathesis (or any condition that may be associated with a prolonged bleeding time). • Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. *Temporary Exclusion Criteria From the SPC: • The concurrent use of FLUENZ with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for influenza antiviral agents to reduce the effectiveness of FLUENZ, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy. 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: • Fever (sublingual temperature = 38°C) • Received any blood or blood products within the past 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Technical version: 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 4-9(+364days) years at enrollment in naïve children vs those in previous receipt of the AS03B adjuvanted pandemic influenza vaccine to homologous vaccine strains . Lay version: To compare the immune system responses to various strains of flu after having the nasal influenza vaccine (LAIV) for each of three consecutive years in children aged 4-8 when they join the study and who have either previously had a dose of Pandemirix (a pandemic flu vaccine) or have never had any pandemic flu vaccine.;Secondary Objective: To document the incidence of laboratory confirmed influenza and other respiratory viruses in the naïve and Pandemrix™ primed children over the three seasons. To compare the safety and tolerability of annual doses of LAIV in naïve compared to Panemrix™ vaccinated children.;Primary end point(s): The measures of immunogenicity, collected for all evaluable subjects include: Geometric mean titre. Least squares GMTs for HI (H3N2, H1N1, H7N9, B) and MN (H1N1 and H7N9) data associated 95% confidence interval and median, minimal, and maximal titre values for study Days 0 and 21 +/- 7 (pre and post bleed). Geometric Mean Ratio. Least squares GMRs will be calculated for the HI, MN results (for all viruses) for Day 21/day0 Percentages of Subjects with Seroconversion or Significant Increase in HI and MN Titre. Seroconversions or significant increase (negative titres at D0; <10 and = 40 at D21 or at least 4-fold increase in titre) in HI titres or MN (for all viruses) from pre-immunization to days 21, will be tabulated for both vaccine groups; Percentages of Subjects achieving each of the following thresholds: HI = 40, MN = 40; MN = 80, four-fold rise in MN titres: The number and proportion of subjects achieving each threshold at study at Days 0, 21will be tabulated for all | — |
Countries
United Kingdom
Contacts
Public ContactSouthern
Health Protection Agency
Outcome results
None listed