Clinical trial in children from 12 to 35 months of the flu vaccine to estimate efficacy against influenza and other respiratory infections

Phase 1

• Conditions: Flu and acute respiratory infections; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2019-001186-33-ES
• Lead Sponsor: FISABIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified