E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
No medical condition applicable |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016794 |
E.1.2 | Term | Flu vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine efficacy of LAIV in a school age UK population |
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E.2.2 | Secondary objectives of the trial |
1. To measure the adverse effect safety profile of LAIV 2. To determine the protective effect of LAIV on non-vaccinated individuals (namely unvaccinated staff and students)
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Immune correlates of protection induced by Live Attenuated Influenza Vaccine (LAIV or Fluenz Tetra) - LAIV PROTECT CORRELATES substudy
Protocol dated 19 June 2015, version 1
The sub-study will work in synergy with the LAIV PROTECT epidemiological main study to determine whether LAIV induces immune parameters previously postulated to be correlates of protection by inviting those being vaccinated in the LAIV PROTECT study to provide research samples. The sub-study will also examine the effect of prior exposure to influenza infection or vaccination on the immune response to LAIV and will use gene expression profiling to search for novel candidate biomarkers or immune correlates of protection. This sub-study will involve taking blood and saliva samples from a sub-set of the main population to investigate:
Primary Objective: 1. To identify potential cellular adaptive and innate immune markers as correlates of protection induced by LAIV
Secondary Objectives:
1. To quantify prevalence of Influenza-specific cross-reactive T cell immunity prior to vaccination and post-vaccination 2. To investigate the total number of Interferon-gamma producing T cells as a potential correlate of vaccine protection 3. To determine the longevity of T cell immunity induced by LAIV vaccination 4. To identify gene expression signatures as potential correlates of protection 5. To quantify ADCC antibodies induced by LAIV vaccination 6. To investigate novel methods of mucosal and systemic antibody detection
The aim is to have both studies reviewed in parallel by the same ethics committee. |
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E.3 | Principal 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)
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Influenza infection determined by PCR-positive nasal swab |
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E.5.1.1 | 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). |
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E.5.2 | Secondary end point(s) |
Influenza-like illness determined by WHO criteria Adverse reactions to vaccination |
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E.5.2.1 | 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).
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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
Immune correlates of protection |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the second flu season after vaccination. Flu seasons will be determined by Public Health England reported timelines. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 31 |