E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children aged 24 months to (and including) 17 years with IgE-mediated food allergy to egg protein |
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E.1.1.1 | Medical condition in easily understood language |
Children aged 24 months to (and including) 17 years with egg allergy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014315 |
E.1.2 | Term | Egg allergy |
E.1.2 | System Organ Class | 100000004870 |
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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 |
Is the administration of the intranasal LAIV influenza ('flu) vaccine safe in children with egg allergy? |
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E.2.2 | Secondary objectives of the trial |
Is the administration of the intranasal LAIV influenza ('flu) vaccine safe in children who have experienced a previous severe allergic reaction (anaphylaxis) to egg? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Aged 2 – 17 years old inclusive
2. Physician-diagnosis of egg allergy on the basis of: a. Positive oral food challenge to egg (conducted under medical supervision) within the last 6 months; OR b. History of convincing clinical reaction AND positive skin prick test to ovalbumin at visit 1; OR c. Evidence of >95% likelihood of egg allergy (on the basis of serum specific IgE or skin prick test (SPT) to ovalbumin within past 12 months) (15) but with no prior history of exposure to egg AND positive skin prick test to ovalbumin at visit 1
3. Written informed consent from parent/guardian +/- assent from the child. |
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E.4 | Principal exclusion criteria |
1. Contraindicated as acutely unwell or current unstable asthma a. Acute wheeze in last 72 hours requiring treatment b. Febrile ≥38.0oC in last 72 hours c. Recent admission to hospital in last 2 weeks for acute asthma
2. Current medication a. Use of asthma reliever medication in last 72 hours b. Recent administration of a medication containing antihistamine within the last 4 days c. Current oral steroid for asthma exacerbation or course completed within last 2 weeks
3. Contraindications to LAIV (notwithstanding allergy to egg protein): a. Hypersensitivity to the active ingredients, to gelatin or to gentamicin (a possible trace residue) b. Previous allergic reaction to an influenza vaccine
4. Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids. NB: LAIV (FluEnz) is not contraindicated for use in individuals with asymptomatic HIV infection; or individuals who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency.
5. Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immediate allergic reaction to Fluenz intranasal vaccination (onset of symptoms within 2 hours following administration) as defined by international criteria (PRACTALL consensus criteria), as per Sampson et al J Allergy Clin Immunol. 2012 130(6):1260-74. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Subjects will be observed for at least 60 minutes following administration of the vaccine. |
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E.5.2 | Secondary end point(s) |
1. Delayed onset allergic reaction (within 72 hours following administration) 2. Adverse events (of non-allergic aetiology) following administration 3. Nasal obstruction (change in nasal patency as determined by acoustic rhinometry) following vaccine administration (in a subgroup of participants) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Delayed events will be assessed by telephone follow-up within 4-7 days of vaccination. Nasal obstruction will be determined at 0, 10 and 30 minutes after administration of vaccine. |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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.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 | 9 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |