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Fluenz (nasal, live)

Fluenz nasal spray suspension

Manufacturer
AstraZeneca UK Limited
Label last updated
24 Aug 2026
Source
Official SmPC ↗

The nasal flu spray: a live but weakened flu virus, squirted into both nostrils, for children from 2 to under 18. This is the trivalent 2026/27 version, which replaced the earlier four-strain Fluenz Tetra.

54 findings, each with the section of the label it comes from.

Ingredients and materials

  • Three live attenuated (weakened) reassortant influenza strains - one A/H1N1, one A/H3N2 and one B/Victoria lineage - each at 10^7.0+/-0.5 fluorescent focus units per 0.2 ml doses.2
  • The viruses are propagated in fertilised hens' eggs from healthy chicken flockss.2
  • Produced in VERO cells by reverse genetic technology; the label states the product contains genetically modified organisms (GMOs)s.2
  • May contain traces of egg proteins such as ovalbumin and of gentamicin; the maximum ovalbumin is less than 0.024 micrograms per doses.2
  • Excipients: sucrose, dipotassium phosphate, potassium dihydrogen phosphate, gelatin, arginine hydrochloride, monosodium glutamate monohydrate, water for injectionss.6.1
  • The formulation matches the WHO recommendation for the Northern Hemisphere 2026/2027 season, so the strains change every years.2

Manufacture, storage and handling

  • Shelf life 15 weeks only - one of the shortest of any vaccine on the UK schedules.6.3
  • Store at 2C to 8C, do not freeze, keep the applicator in the outer carton to protect from lights.6.4
  • May be taken out of the refrigerator once for a maximum of 12 hours at up to 25C; at the end of that period it must be used immediately or discardeds.6.4
  • Nasal use only, in a single-use applicator; do not use with a needle and do not injects.6.6
  • Do not use if the expiry date has passed or the sprayer appears damaged, for example if the plunger is loose, displaced, or there are signs of leakages.6.6
  • Administered as a divided dose, half in each nostril, immediately or shortly after one another; the patient breathes normally and does not need to sniffs.4.2, 6.6
  • Must not be mixed with other medicinal products; no compatibility studies exists.6.2

Safety findings

  • Children 2 to 8 who have not had a seasonal flu vaccine before need a second dose at least 4 weeks laters.4.2
  • Must not be used in children under 2 because of safety concerns about increased rates of hospitalisation and wheezing in that age groups.4.2
  • Contraindicated in hypersensitivity to the active substances, excipients, or to gentamicin as a possible trace residues.4.3
  • Contraindicated after a severe allergic reaction such as anaphylaxis to eggs or egg proteins such as ovalbumins.4.3
  • Contraindicated in clinical immunodeficiency from conditions or immunosuppressive therapy, including acute and chronic leukaemias, lymphoma, symptomatic HIV infection, cellular immune deficiencies and high-dose corticosteroidss.4.3
  • Not contraindicated in asymptomatic HIV, or in people on topical or inhaled corticosteroids, low-dose systemic corticosteroids, or corticosteroids as replacement therapy for example for adrenal insufficiencys.4.3
  • Contraindicated in anyone under 18 receiving salicylate therapy, because of the association of Reye's syndrome with salicylates and wild-type influenza infections.4.3
  • Salicylates should not be used for 4 weeks after vaccination unless medically indicateds.4.5
  • Should not be given to children or adolescents with severe asthma or who are currently wheezing, because these individuals have not been adequately studieds.4.4
  • Vaccination should be postponed during severe acute febrile illness or acute infection, and in people with nasal blockage, because of the potential for reduced vaccine uptake and the absence of efficacy data in that groups.4.4
  • This is a live virus vaccine and has the potential for transmission to immunocompromised contacts; recipients should try to avoid close association with severely immunocompromised people, such as bone marrow transplant recipients requiring isolation, for 1 to 2 weeks after vaccinations.4.4
  • Peak incidence of vaccine virus recovery was 2 to 3 days after vaccination in clinical studies, so vaccinated children do shed the vaccine viruss.4.4
  • The effectiveness of preventing influenza disease in immunocompromised individuals has not been evaluateds.4.4
  • No data exist on the safety of intranasal administration in children with unrepaired craniofacial malformationss.4.4
  • Fainting has been observed after intranasal administrations.4.4, 4.8
  • Co-administration with inactivated vaccines 'has not been studied's.4.5
  • Concurrent use with influenza antivirals 'has not been evaluated'; the vaccine should not be given until 48 hours after influenza antiviral therapy stops, and antivirals within two weeks of vaccination may affect the responses.4.5
  • Pregnancy: there is a moderate amount of data, from 138 pregnant women in a US health insurance claims database and more than 300 case reports in the AstraZeneca safety database, with no unusual patterns observed, but the vaccine is not recommended during pregnancys.4.6
  • Breastfeeding: limited evidence suggests the vaccine is not excreted in breastmilk, but because data are limited and some viruses are excreted in human milk it should not be used during breastfeedings.4.6
  • Fertility: no data exist on possible effects on male and female fertilitys.4.6
  • An increased rate of hospitalisation for any cause through 180 days after the final dose was seen in infants 6 to 11 months old: 6.1 per cent with Fluenz against 2.6 per cent with injectable flu vaccine. Most were for gastrointestinal and respiratory infections and occurred more than 6 weeks after vaccination. The rate was not increased in recipients 12 months and olders.4.8
  • An increased rate of wheezing through 42 days was seen in infants and toddlers 6 to 23 months old: 5.9 per cent against 3.8 per cent with injectable vaccine. The rate was not increased in recipients 2 years and olders.4.8
  • Very common reactions: decreased appetite, nasal congestion or runny nose, malaises.4.8
  • Common reactions: headache, muscle aches, fevers.4.8
  • Uncommon reactions: hypersensitivity reactions including facial oedema and urticaria, nosebleed, rashs.4.8
  • Listed at frequency not known from post-marketing experience: anaphylactic reactions, syncope, Guillain-Barre syndrome, and exacerbation of symptoms of Leigh syndrome (mitochondrial encephalomyopathy)s.4.8
  • Safety in children with mild to moderate asthma has been established, but data in children with other pulmonary diseases or with chronic cardiovascular, metabolic or renal diseases are limiteds.4.8
  • Most of the safety data comes from the earlier four-strain version: over 29,000 children in clinical studies and over 84,000 in post-authorisation safety studiess.4.8
  • Overdose is unlikely because of the single-use applicator presentation; rare reports of higher than recommended doses showed a comparable adverse reaction profiles.4.9

Evidence and claims

  • Efficacy data come from 9 controlled studies covering over 20,000 infants, children and adolescents across 7 influenza seasonss.5.1
  • Against matched strains, efficacy ranged from 62.2 per cent in one season to 93.4 per cent in another; against all strains regardless of match it fell to 48.6 per cent in one study season and 63.8 per cent in anothers.5.1
  • In children given 2 doses in year 1 and a placebo in year 2, efficacy was much lower: 56.2 per cent and 57.0 per cent, which the label presents as supporting the need for annual revaccinations.5.1
  • A single dose in previously unvaccinated children gave efficacy of 88.8 per cent in one study and 57.7 per cent in anothers.5.1
  • In active-controlled studies against injectable flu vaccine, the relative improvement was 44.5 per cent, 52.7 per cent and 34.7 per cent against matched strains, with wide confidence intervals in two of the three (21.6 to 72.2, and 3.9 to 56.0)s.5.1
  • The vaccine replicates in the nasopharynx and induces immune responses against the strains it containss.5.1
  • Preclinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, reproduction and developmental toxicity, local tolerance and neurovirulences.5.3

Document and licensing

  • Marketing authorisation holder: AstraZeneca UK Limited, Cambridges.7
  • Date of first authorisation: 26 June 2024 - this trivalent version is a newer product than the four-strain Fluenz Tetra it replaceds.9
  • Text last revised 13 August 2026, for the 2026/2027 seasons.10
  • Safety data from the withdrawn four-strain product remain in the label, presented as relevant because the two are made the same ways.4.8
  • Suspected reactions are reported through the MHRA Yellow Card schemes.4.8

Every line above is a summary of a statement in the manufacturer's own label, with the section number it comes from. Nothing has been added from any other source. The full list of flagged sentences is below, as it came out of the document.

Listed ingredients

Section 2 - qualitative and quantitative composition source ↗

Reassortant influenza virus* (live attenuated) of the following three strains**:
 A/Missouri/11/2025 (H1N1)pdm09-like strain
 (A/Switzerland/6849/2025, MEDI 400592)     10^7.0±0.5 FFU***
 A/Darwin/1454/2025 (H3N2)-like strain 
 (A/Darwin/1369/2025, MEDI 406666)       10^7.0±0.5 FFU***
 B/Tokyo/EIS13-175/2025-like strain 
 (B/Perth/115/2025, MEDI 407730)         10^7.0±0.5 FFU***
 ....................................................................................................................per 0.2 ml dose
 * Propagated in fertilised hens' eggs from healthy chicken flocks.
 ** Produced in VERO cells by reverse genetic technology. This product contains genetically modified organisms (GMOs).
 *** Fluorescent Focus Units.
 This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision for the 2026/2027 season.
 The vaccine may contain traces of the following substances: egg proteins (e.g. ovalbumin) and gentamicin. The maximum amount of ovalbumin is less than 0.024 micrograms per 0.2 ml dose (0.12 micrograms per ml), see section 4.3.
 For the full list of excipients, see section 6.1.

What these are, in plain English

  • attenuated - Weakened on purpose so the organism cannot cause the disease in a healthy person.
  • vero - VERO cells: a laboratory-grown line of kidney cells originally taken from an African green monkey in 1962. Cells, not animal tissue, and they are not present in the finished vaccine.
  • genetically modified - Made using genetic engineering.
  • ovalbumin - The main protein in egg white. It is left over from growing the virus in hens' eggs, and it is why a severe egg allergy is a contraindication.
  • gentamicin - An antibiotic used during manufacture to stop bacteria growing. Traces may remain, which is why a gentamicin allergy is a contraindication.

Other ingredients (excipients)

Section 6.1 source ↗

  • SucroseSugar. Used as a stabiliser so the vaccine keeps its potency in storage.
  • Dipotassium phosphateA phosphate buffer, used to hold the liquid at a steady acidity.
  • Potassium dihydrogen phosphate
  • GelatinA protein made by boiling animal collagen. Porcine gelatin comes from pig skin or bone; hydrolysed gelatin is broken into smaller pieces. Used as a stabiliser, and it is the reason some people with a gelatin allergy cannot have this vaccine.
  • Arginine hydrochlorideArginine is an amino acid, one of the building blocks of protein. Here it keeps the liquid at a steady acidity.
  • Monosodium glutamate monohydrateThe flavour enhancer known as MSG, a salt of the amino acid glutamate. Here it acts as a stabiliser, not a flavour.
  • Water for injectionsPurified water to the standard used for injected medicines. It is the liquid the other ingredients are dissolved in.
Audit trail: every flagged sentence in the document (41)

These are the sentences the mechanical filter pulled out, in the document's own words, grouped by section. They are what the briefing above was built from, kept here so you can check nothing was left out. Some are fragments and some are technical, which is why the briefing exists.

4.2 Posology and method of administration

  1. Fluenz should not be used in infants and toddlers below 2 years of age because of safety concerns regarding increased rates of hospitalisation and wheezing in this population (see section 4.8).

    Section 4.2 Posology and method of administration source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.

    Not recommended, contraindicated or restricted matched: should not be used

4.3 Contraindications

  1. • Hypersensitivity to the active substances or, to any of the excipients listed in section 6.1 or to gentamicin (a possible trace residue).

    Section 4.3 Contraindications source ↗

    In plain English

    • hypersensitivity - An allergic-type reaction, from a mild rash up to a severe reaction.

    Trace residues and process chemicals matched: gentamicin

  2. • Severe allergic reaction (e.g. anaphylaxis) to eggs or to egg proteins (e.g. ovalbumin).

    Section 4.3 Contraindications source ↗

    In plain English

    • anaphylaxis - A severe, sudden allergic reaction that can make breathing difficult and needs urgent medical treatment.

    Animal, human or cell-line derived materialTrace residues and process chemicals matched: egg, ovalbumin

  3. 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.

    Section 4.3 Contraindications source ↗

    In plain English

    • contraindicated - A situation where the medicine should not be given at all.

    Not recommended, contraindicated or restricted matched: contraindicated

  4. • 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 (see section 4.5).

    Section 4.3 Contraindications source ↗

    In plain English

    • reye - Reye's syndrome: a rare and serious illness affecting the brain and liver that can follow a viral infection in children given aspirin-type medicines.

    Immune system, shedding and transmissionRare or very rare serious events matched: reye

4.4 Special warnings and precautions for use

  1. Vaccination should also be postponed in individuals with nasal blockage, due to the potential for reduced vaccine uptake and the absence of efficacy data in this population.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  2. Vaccine recipients should be informed that Fluenz is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • transmission - Passing something from one person to another.
    • attenuated - Weakened on purpose so the virus or bacterium can no longer cause the disease in a healthy person.

    Genetic engineering, vectors and GMOsImmune system, shedding and transmission matched: attenuated, immunocompromised

  3. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.

    Immune system, shedding and transmission matched: immunocompromised

  4. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • transmission - Passing something from one person to another.

    Immune system, shedding and transmission matched: immunocompromised

  5. The effectiveness of Fluenz preventing influenza disease in immunocompromised individuals has not been evaluated (see section 4.8).

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.
    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpointsImmune system, shedding and transmissionNo data / not studied matched: effectiveness, has not been evaluated, immunocompromised

  6. No data exist regarding the safety of intranasal administration of Fluenz in children with unrepaired craniofacial malformations.

    Section 4.4 Special warnings and precautions for use source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

4.5 Interaction with other medicinal products and other forms of interaction

  1. Fluenz must not be administered to children and adolescents receiving salicylate therapy (see section 4.3).

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    Not recommended, contraindicated or restricted matched: must not be administered

  2. Salicylates should not be used in children and adolescents for 4 weeks after vaccination unless medically indicated as Reye's syndrome has been reported following the use of salicylates during wild-type influenza infection.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.
    • reye - Reye's syndrome: a rare and serious illness affecting the brain and liver that can follow a viral infection in children given aspirin-type medicines.

    Immune system, shedding and transmissionRare or very rare serious eventsNot recommended, contraindicated or restricted matched: reye, should not be used

  3. Fluenz can be administered concomitantly with the live attenuated vaccines: measles, mumps, rubella, varicella, and orally-administered poliovirus.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  4. The co-administration of Fluenz with inactivated vaccines has not been studied.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • has not been studied - No trial has been run for this group or this situation.
    • inactivated - Killed. The organism cannot replicate at all.

    No data / not studied matched: has not been studied

  5. The concurrent use of Fluenz with antiviral agents that are active against influenza A and/or B viruses has not been evaluated.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • has not been evaluated - It has not been tested or measured in this group or situation.

    No data / not studied matched: has not been evaluated

  6. However, based upon the potential for influenza antiviral agents to reduce the effectiveness of Fluenz, it is recommended not to administer the vaccine until 48 hours after the cessation of influenza antiviral therapy.

    Section 4.5 Interaction with other medicinal products and other forms of interaction source ↗

    In plain English

    • effectiveness - How well it works in ordinary use in the real world.

    Efficacy, effectiveness and endpoints matched: effectiveness

4.6 Fertility, pregnancy and lactation

  1. In more than 300 case reports in the AstraZeneca safety database of vaccine administration to pregnant women, no unusual patterns of pregnancy complications or foetal outcomes were observed.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Animal, human or cell-line derived material matched: foetal

  2. While animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, and post-marketing data offer some reassurance in the event of inadvertent administration of the vaccine, Fluenz is not recommended during pregnancy.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • reproductive toxicity - Harm to fertility or to an unborn baby.
    • not recommended - The manufacturer advises against it. This is weaker than 'contraindicated', which means it must not be given.
    • post-marketing - After the product went on the market and was given to the public, as opposed to during the original clinical trials.

    Not recommended, contraindicated or restricted matched: not recommended

  3. Limited available evidence suggests that Fluenz is not excreted in breastmilk.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    Limited, insufficient or inconclusive matched: limited available

  4. However, because there are limited data to assess the effects on the breast-fed infant and as some viruses are excreted in human milk, Fluenz should not be used during breast-feeding.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • should not be used - The label says the product should not be given in this situation.
    • limited data - Only a small amount of information exists on this point, so firmer conclusions cannot be drawn.

    Limited, insufficient or inconclusiveNot recommended, contraindicated or restricted matched: limited data, should not be used

  5. No data exist regarding the possible effects of Fluenz on male and female fertility.

    Section 4.6 Fertility, pregnancy and lactation source ↗

    In plain English

    • no data - The label is stating that no study has measured this. It is a statement about what was tested, not about what was found.

    No data / not studied matched: no data

4.8 Undesirable effects

  1. Safety data regarding use of Fluenz are based on data from Fluenz clinical studies in over 29 000 children and adolescents 2 to 17 years of age, Fluenz post-authorisation safety studies in over 84 000 children and adolescents 2 to 17 years of age, and data from influenza vaccine (live attenuated, nasal) tetravalent clinical studies in over 2 000 children and adolescents 2 to 17 years of age.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  2. Additional experience has occurred with marketed use of Fluenz and /or influenza vaccine (live attenuated, nasal) tetravalent.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  3. In clinical studies, the safety profile of Fluenz and influenza vaccine (live attenuated, nasal tetravalent were similar.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • live attenuated - A vaccine containing a weakened but still living organism. It can still replicate in the body and, with a nasal flu vaccine, be passed on.

    Genetic engineering, vectors and GMOs matched: attenuated

  4. very rare (<1/10 000) and not known (cannot be estimated from available data).

    Section 4.8 Undesirable effects source ↗

    In plain English

    • very rare - In the label's frequency scale, this means it happened in up to 1 in 10,000 people. Often these are reports sent in after a vaccine is in use rather than findings from a formal study.
    • not known - The label's lowest band: the number of cases is too small, or the reporting too patchy, to work out how often it happens.

    No data / not studiedRare or very rare serious events matched: not known, very rare

  5. Fluenz is not indicated for use in infants and toddlers younger than 2 years (see section 4.2).

    Section 4.8 Undesirable effects source ↗

    Not recommended, contraindicated or restricted matched: is not indicated

  6. In HIV-infected children (n=24) and HIV-negative children (n=25) 1 through 7 years of age, and in HIV-infected children and adolescents 5 through 17 years of age receiving stable anti-retroviral therapy (Fluenz: n=122, trivalent injectable vaccine: n=121), the frequency and duration of vaccine virus shedding were comparable to that seen in healthy individuals.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • shedding - The vaccine organism being released from the body, for example in nasal mucus, and possibly passing to other people.

    Immune system, shedding and transmission matched: shedding

  7. Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had recently received chemotherapy) were randomised 1:1 to Fluenz or placebo.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • randomised - A trial where people are assigned to groups by chance.
    • placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.

    Immune system, shedding and transmission matched: immunocompromised

  8. Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents.

    Section 4.8 Undesirable effects source ↗

    In plain English

    • immunocompromised - Having a weakened immune system, from illness or from medicines such as chemotherapy.
    • shedding - The vaccine organism being released from the body, for example in nasal mucus, and possibly passing to other people.

    Immune system, shedding and transmission matched: immunocompromised

5.1 Pharmacodynamic properties

  1. Fluenz is a trivalent vaccine that contains three cold-adapted (ca); temperature-sensitive (ts); and attenuated (att) influenza virus strains, an A/(H1N1) strain, an A/(H3N2) strain, and a B strain from the Victoria lineage.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • attenuated - Weakened on purpose so the virus or bacterium can no longer cause the disease in a healthy person.

    Genetic engineering, vectors and GMOs matched: attenuated

  2. Fluenz's efficacy data in the paediatric population consist of 9 controlled studies comprising over 20 000 infants and toddlers, children and adolescents, conducted during 7 influenza seasons.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  3. See Table 2 and 3 for a summary of efficacy results in the paediatric population.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  4. Table 2 Fluenz efficacy after 2 doses against culture-confirmed influenza illness in placebo controlled paediatric studies

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.
    • placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  5. In clinical studies AV006 and D153-P504, the efficacy of a single dose of Fluenz was evaluated in previously unvaccinated children aged 15-71 months (n=288) and aged 6-35 months (n=1 877).

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  6. The efficacy against culture-confirmed influenza caused by any matched strain was 88.8% (95% CI: 64.5, 96.5) and 57.7% (95% CI: 44.7, 67.9), respectively.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  7. Fluenz efficacy estimates against all matched strains in children who received 2 doses in year 1 and revaccination in year 2 was 100% (95% CI: 38.2, 100; n=1 110) in AV006, 84.3% (95% CI: 70.1, 92.4; n=1 265) in D153-P501, 88.7% (95% CI: 82.0, 93.2; n=1 090) in D153-P502 and 73.6% (95% CI: 33.3, 91.2; n=680) in D153-P504.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  8. Fluenz efficacy estimates against all matched strains in children who received 2 doses in year 1 and placebo in year 2 were lower: 56.2% (95% CI: 30.5, 72.7; n=1 253) in D153-P501 and 57.0% (95% CI: 6.1, 81.7; n=718) in D153-P504.

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • efficacy - How well it works in the controlled conditions of a trial.
    • placebo - A dummy injection with no active ingredient, used as a comparison group in a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

  9. Table 3 Fluenz relative efficacy against culture-confirmed influenza illness in active-controlled paediatric studies with injectable influenza vaccine

    Section 5.1 Pharmacodynamic properties source ↗

    In plain English

    • active-controlled - A trial where the comparison group gets another real vaccine, not a dummy.
    • efficacy - How well it works in the controlled conditions of a trial.

    Efficacy, effectiveness and endpoints matched: efficacy

6.6 Special precautions for disposal and other handling

  1. • Do not use with a needle.

    Section 6.6 Special precautions for disposal and other handling source ↗

    Not recommended, contraindicated or restricted matched: do not use

  2. • Do not use Fluenz if the expiry date has passed or the sprayer appears damaged, for example, if the plunger is loose or displaced from the sprayer or if there are any signs of leakage.

    Section 6.6 Special precautions for disposal and other handling source ↗

    Not recommended, contraindicated or restricted matched: do not use

Read the whole document at the source ↗