Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2–49years

Baxter, Roger; Eaton, Abigail; Hansen, John; Aukes, Laurie; Caspard, Hervé; Ambrose, Christopher S.

doi:10.1016/j.vaccine.2017.01.062

Cited by 25 publications

(16 citation statements)

References 12 publications

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“…To try to circumvent this problem, several manufacturers have developed quadrivalent inactivated influenza vaccines, including Sanofi Pasteur, Green Cross, GlaxoSmithKline, SK Chemicals and Seqirus [29]. A quadrivalent LAIV was licensed in the USA in 2012 by MedImmune and is now in use in the USA, Canada and some European countries [30]. The main argument in favor of use of quadrivalent vaccines is the above mentioned potential mismatch between the influenza vaccine B component and the major epidemic B virus strain.…”

Section: Discussionmentioning

confidence: 99%

Rationale for vaccination with trivalent or quadrivalent live attenuated influenza vaccines: Protective vaccine efficacy in the ferret model

et al. 2018

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Background and aimThe majority of seasonal influenza vaccines are trivalent, containing two A virus strains (H1N1 and H3N2) and one B virus strain. The co-circulation of two distinct lineages of B viruses can lead to mismatch between the influenza B virus strain recommended for the trivalent seasonal vaccine and the circulating B virus. This has led some manufacturers to produce quadrivalent influenza vaccines containing one strain from each B lineage in addition to H1N1 and H3N2 strains. However, it is also important to know whether vaccines containing a single influenza B strain can provide cross-protectivity against viruses of the antigenically distinct lineage. The aim of this study was to assess in naïve ferrets the potential cross-protective activity of trivalent live attenuated influenza vaccine (T-LAIV) against challenge with a heterologous wild-type influenza B virus belonging to the genetically different lineage and to compare this activity with effectiveness of quadrivalent LAIV (Q-LAIV) in the ferret model.Methods and resultsFerrets were vaccinated with either one dose of trivalent LAIV containing B/Victoria or B/Yamagata lineage virus, or quadrivalent LAIV (containing both B lineages), or placebo. They were then challenged with B/Victoria or B/Yamagata lineage wild-type virus 28 days after vaccination. The ferrets were monitored for clinical signs and morbidity. Nasal swabs and lung tissue samples were analyzed for the presence of challenge virus. Antibody response to vaccination was assessed by routine hemagglutination inhibition assay. All LAIVs tested were found to be safe and effective against wild-type influenza B viruses based on clinical signs, and virological and histological data. The absence of interference between vaccine strains in trivalent and quadrivalent vaccine formulations was confirmed. Trivalent LAIVs were shown to have the potential to be cross-protective against infection with genetically different influenza B/Victoria and B/Yamagata lineages.ConclusionsIn this ferret model, quadrivalent vaccine provided higher protection to challenge against both B/Victoria and B/Yamagata lineage viruses. However, T-LAIV provided some cross-protection in the case of a mismatch between circulating and vaccine type B strains. Notably, B/Victoria-based T-LAIV was more protective compared to B/Yamagata-based T-LAIV.

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Section: Discussionmentioning

confidence: 99%

Rationale for vaccination with trivalent or quadrivalent live attenuated influenza vaccines: Protective vaccine efficacy in the ferret model

et al. 2018

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“…LAIV, whether trivalent or quadrivalent, is safe, without any increased risk after administration. 124 , 154 The vaccine is currently approved in the USA, Europe, India and Russia for subjects aged 2–49 years. However, it has also been evaluated in adults and the elderly.…”

Section: Adults and The Elderlymentioning

confidence: 99%

“… 155 , 156 No significant AEs following LAIV vaccination have been reported 51 with the exception of upper and lower respiratory tract infections, wheezing, rhinitis and sneezing. 124 , 156 , 157 …”

Section: Adults and The Elderlymentioning

confidence: 99%

Influenza vaccines: Evaluation of the safety profile

Trombetta

Gianchecchi

Montomoli

2018

Human Vaccines & Immunotherapeutics

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The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated.Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines. Both display a good safety profile in adults and children. However, they can cause adverse events and/or rare adverse events, some of which are more prevalent in children, while others with a higher prevalence in adults.The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods.

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“…In a phase 3 trial of LAIV versus IIV, an increase in all-cause hospitalisation was noted in a subset of LAIV3 recipients aged 6 to 11 months of age, that is, in patients younger than the recommended age for LAIV use (≥2 years of age) 3. Larger postmarketing studies using vaccine administration and safety data from the Kaiser Permanente integrated medical care system have evaluated the risk of hospitalisation in children (≥2 years of age) following the receipt of LAIV314 15 and LAIV4 16. A total of more than 70 000 paediatric LAIV recipients were documented and, while an elevated risk of hospitalisation was not seen in either of the studies, it is worth noting that they documented mostly healthy children.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink

et al. 2018

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ObjectivesTo assess the safety of live attenuated influenza vaccine (LAIV) in children in high-risk groups.DesignNon-interventional cohort study.SettingEngland during 2013–2014 and 2014–2015 influenza seasons.ParticipantsLAIV recipients identified from the Clinical Practice Research Datalink, aged 2–17 years, and with at least one underlying high-risk condition. LAIV recipients were matched with inactivated influenza vaccine (IIV) recipients and unvaccinated controls.Primary outcome measuresPrimary safety endpoints were any hospitalisation documented in the linked Hospital Episodes Statistics database within 42 days and up to 6 months after vaccination.Results11 463 children and adolescents were included: 4718 received the trivalent LAIV formulation during the 2013–2014 influenza season and 6745 received the quadrivalent formulation during the 2014–2015 influenza season. The risks of hospitalisation within 42 days were 231 per 1000 person-years (95% CI 193 to 275) in season 2013–2014 and 231 (95% CI 198 to 267) in season 2014–2015. These risks were not significantly different when compared with matched unvaccinated children (relative risks (RR) 0.96 (95% CI 0.78 to 1.19) in season 2013–2014, 0.90 (95% CI 0.76 to 1.07) in season 2014–2015) and consistently lower than after IIV administration (RR 0.47 (95% CI: 0.37 to 0.59) in season 2013–2014, 0.42 (95% CI 0.35 to 0.51) in season 2014–2015). A similar pattern was observed up to 6 months postvaccination with a risk of hospitalisation after LAIV administration that did not differ from what was observed in unvaccinated controls and was lower than after IIV administration.ConclusionsThis study did not identify new safety concerns associated with the administration of LAIV in children and adolescents with high-risk conditions. However, as with any other observational study, treatment administration was not randomly assigned and our findings may be confounded by differences between the groups at baseline.Trial registration numberEUPAS18527.

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Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2–49years

Abstract: ClinicalTrials.gov NCT01985997.

Cited by 25 publications

References 12 publications

Rationale for vaccination with trivalent or quadrivalent live attenuated influenza vaccines: Protective vaccine efficacy in the ferret model

Rationale for vaccination with trivalent or quadrivalent live attenuated influenza vaccines: Protective vaccine efficacy in the ferret model

Influenza vaccines: Evaluation of the safety profile

Evaluation of the safety of live attenuated influenza vaccine (LAIV) in children and adolescents with asthma and high-risk conditions: a population-based prospective cohort study conducted in England with the Clinical Practice Research Datalink

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