Flu and acute respiratory infections
Conditions
Interventions
Trade Name: Fluarix tetra
Product Name: Fluarix Tetra
Pharmaceutical Form: Injection
INN or Proposed INN: A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE STRAIN (A/
Sponsors
FISABIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects of both sexes who are between 12 to 35 months of age (both inclusive) with a history of recurrent or severe ARI defined as: a. three or more acute respiratory infections diagnosed in primary care (rhinitis, acute otitis media, pharyngitis, bronchitis, bronchiolitis or pneumonia) in the previous 6 months or four or more in the last 12 months; or b. a recurrent acute respiratory infection referral to the emergency department or the otorhinolaryngology specialist in the last 12 months; or c. an hospitalization by acute respiratory infection in the last 12 months. 2. Informed consent of the parents or legal representatives of the subject. 3. Subject and parent or other legally authorized representative, can and are willing to attend scheduled visits and accept all trial procedures. 4. Willingness to use the mobile tracking application while the participation in the study lasts. Are the trial subjects under 18? yes Number of subjects for this age range: 400 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: 1. Child in foster care, without legal tutor. 2. Planned administration of any influenza vaccine (other than the study vaccine) during the entire study period, according to the official immunization schedule. 3. Anaphylaxis known to the active ingredients or to any of the excipients included in the influenza vaccine data sheet or to any component that may be present in trace amounts, such as egg (ovalbumin, etc.). 4. Anaphylaxis known to the active ingredients or to any of the excipients included in the hepatitis A vaccine data sheet. 5. Any immunological disorder or medical condition that at the discretion of the pediatrician contraindicates vaccination against influenza or hepatitis A. 6. Any treatment with chronic immunosuppressants (defined as more than 14 days) or other immunological treatment in the three months prior to the first dose of the vaccine or during the study. Topical use of corticosteroids (for example, cream, drops or aerosols), within the dose indicated on the product label, is allowed. 7. Administration of immunoglobulins and / or any blood product (transfusion) within 3 months before the first dose of the study vaccine or planned administration during the study period. 8. Have received any influenza vaccine or have been diagnosed with influenza in the same season (confirmed by laboratory diagnostic tests or rapid influenza). 9. Have been previously vaccinated against hepatitis A. 10. Have a fever and / or an acute illness or infection on the day of vaccination, defining fever as an axillary temperature =38.0°C. Immunization will be postponed until fever disappears. 11. Planned surgery that requires a general anesthetic or planned surgery that requires hospitalization for at least 24 hours during the entire study period. 12. Have participated in the first year of this study. 13. Do not authorize the laboratory results to be recorded in the clinical record.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effectiveness of the inactivated flu vaccine with the number of episodes of acute respiratory infections, its severity and its complications in children with risk.; Secondary Objective: To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections, its severity and its complications in children at risk by sex. To estimate the effectiveness of the inactivated flu vaccine against the number of flu infections confirmed by laboratory. To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with non-influenza virus isolation. To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with detection of respiratory viruses (influenza and not influenza). To analyze the consumption of resources in vaccinated and unvaccinated children with acute respiratory infections. ;Primary end point(s): To estimate the efficacy of the influenza vaccine against the number of episodes of acute respiratory infection, its severity and its complications in children at risk. These are chosen as measures of net health effects and to analyze whether the vaccine causes viral interference.;Timepoint(s) of evaluation of this end point: After each flu season (2020 and 2021), for two consecutive seasons. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections, its severity and its complications in children at risk by sex. To estimate the effectiveness of the inactivated flu vaccine against the number of flu infections confirmed by laboratory. To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with non-influenza virus isolation. To estimate the effectiveness of the inactivated flu vaccine against the number of episodes of acute respiratory infections with detection of respiratory viruses (influenza and not influenza). To analyze the consumption of resources in vaccinated and unvaccinated children with acute respiratory infections. ;Timepoint(s) of evaluation of this end point: September 2021 | — |
Countries
Spain
Contacts
Public ContactAIV
FISABIO
Outcome results
None listed