Effictiveness and safety of vaccination with Live-attenuated Influenza Vaccine

Phase 1

Active, not recruiting

Conditions: There is no medical condition associated with this trial. The trial involves vaccination of healthy children with a licensed product according to the SmPC. The vaccination is Fluenz Tetra, a live-attenuated nasal spray vaccine to protect against influenza infection.
MedDRA version: 20.0 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2015-003250-41-GB

Lead Sponsor: Public Health England

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: Not specified

Target Recruitment: 2500

Inclusion Criteria

- Healthy children aged 10 to 16 (born between 1/9/2005 and 1/9/1999) or staff at the participating school sites of any age
- Children must be enrolled and attending one of the two schools study sites in the 2015/16 school year.
- Staff must be working at one of the 2 school study sites in the 2015/16 school year.
- Relevant consent, parental/guardian consent and participant assent or participant consent (age dependant)

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
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

- Any current or previous condition/circumstance that, in the opinion of the investigator, may put the individual at risk if participating in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine efficacy of LAIV in a school age UK population;<br> Secondary Objective: 1. To measure the adverse effect safety profile of LAIV<br> 2. To determine the protective effect of LAIV on non-vaccinated individuals (namely unvaccinated staff and students)<br> ;Primary end point(s): Influenza infection determined by PCR-positive nasal swab;Timepoint(s) of evaluation of this end point: Nasal swabs will be taken any time the participant experiences an influenza-like illness (where they have a cough, cold, sort throat or temperature). These will be taken during the flu season only and taken throughout each flu season they are involved in the study (2 flu seasons total, approx 1.5 years).

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Influenza-like illness determined by WHO criteria<br> Adverse reactions to vaccination<br> ;<br> Timepoint(s) of evaluation of this end point: Reporting of flu-like illness and symtpoms will be determined using weekly questionnaires during the flu season only. These will be taken during the flu season only and taken throughout each flu season they are involved in the study (2 flu seasons total, approx 1.5 years).<br><br> Adverse symptoms resulting from vaccination will be recorded for 1 week post-vaccination. Any further adverse symptoms relating to vaccination will be recorded as they occur for the duration of the study.<br>