Influenza MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Fluad/J07BB02/Suspension for injection
Pharmaceutical Form: Suspension for injection
Other descriptive name: A/California/7/2009 (H1N1)-like influenza virus strain
Concentration unit: µg m
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female children who have received two doses of at least one of the study vaccines in the previous V70P5 trial, influenza season 2008/2009 or 2009/2010. - Children's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements. - Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 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: - Children with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. - Children with any progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome. - Children's parents or legal guardian who are not able to comprehend and to follow all required study procedures for the whole period of the study. - Children with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. - Children with suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. - Children with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. - Children with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). - Children who have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. - Children with history of allergy to vaccine components. - Children participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. - Children who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines. - Children who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. - Children who have received antibiotics within 6 days before vaccination. Individuals who are family members of study personnel conducting this study. Individuals with axillary temperature =37.3 degrees Celsius within 3 days of intended study vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of full dose FLUAD during the extension study • To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of half dose FLUAD during the extension study. • To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of an unadjuvanted influenza vaccine during the extension study;Secondary Objective: To evaluate the immunogenicity as specified in the above three Coprimary objective, but using CBER criteria instead of CHMP criteria. To compare the immunogenicity of the randomization permutations (as per Table 1 of protocol). If the sample size is sufficient, the vaccine group differences and ratios will be assessed versus the non-inferiority margin of 1.5 for GMT ratios and 10% for difference in proportions. - To assess immunogenicity data for each Homologous virus strains using CHMP, stratified by influenza seasonal and pandemic vaccine type received during the interim non-study period. - To describe the immunogenicity of the randomization permutations (as per Table 1) as measured by MN testing. Safety Objectives: - To evaluate the safety and tolerability of a dose of FLUAD? or a dose of Agrippal administered to subjects in this extension study in sub-groups according to previous influenza vaccine type received in the initial study and non-study interim period ;Primary end point(s): Immunogenicity Endpoints The measures for immunogenicity as determined by HI are as follows: 1. Geometric mean HI titer (GMT) on Visit 1, 2, AND 3, as applicable; 2. Visit 2/Visit 1, Visit 3/Visit 1, geometric mean ratio (GMR) of HI, as applicable; 3. Percentage of subjects achieving seroconversion or a significant increase (defined as: HI = 40 for subjects negative at baseline [< 10]; a minimum 4-fold increase in HI titer for subjects positive at baseline [HI = 10]) | — |
Countries
Finland
Outcome results
None listed