Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age

Greenberg, David; Robertson, Corwin A.; Landolfi, Victoria; Bhaumik, Amitabha; Senders, Shelly; Decker, Michael D.

doi:10.1097/inf.0000000000000254

Cited by 42 publications

(32 citation statements)

References 18 publications

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“…Immunogenicity against the 3 strains common to both vaccines was similar, indicating that addition of the second B strain does not affect immunogenicity of the other influenza strains. A study of Sanofi Pasteur's QIV in young children also supported that the addition of a second B strain has no negative impact on the immune responses to other strains, albeit at a dose of 7.5 μg HA [20]. There were no treatment group differences within either age strata.…”

Section: Discussionmentioning

confidence: 86%

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Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial

Wang¹,

Chandrasekaran

Domachowske

et al. 2015

J Ped Infect Dis

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BackgroundViruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection.MethodsWe compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6–35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314).ResultsSeroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%–86.6%), 72.0% (95% CI, 63.9%–79.2%), 86.0% (95% CI, 79.2%–91.2%), and 66.4% (95% CI, 58.1%–74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%–5.99%) and SCR difference of 54.02% (95% CI, 43.88%–62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination.ConclusionsQuadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6–35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group.

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Section: Discussionmentioning

confidence: 86%

“…Immunogenicity and safety of inactivated QIVs have been evaluated in adults [21–24] and children [20, 25–27]. In all studies, the QIVs produced superior immune responses to the B lineage not contained in the control TIV and a comparable response to the common vaccine strains.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial

Wang¹,

Chandrasekaran

Domachowske

et al. 2015

J Ped Infect Dis

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“…Most local and general adverse events are temporary and mild to moderate in severity. Among children, the most common safety complaint was a modest increase in injection-site pain (124,126,128,300). The first postlicensure review of VAERS reports covering the 2013-14 and 2014-15 seasons noted that the most common adverse events reported following receipt of IIV4 among children aged 6 months through 17 years were injection-site reactions and fever.…”

Section: Safety Of Inactivated Influenza Vaccines Childrenmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines

Grohskopf

Sokolow²,

Broder³

et al. 2016

MMWR Recomm. Rep.

384

279

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“…A randomized, repeated measure study on usability and acceptability of MNPs for influenza vaccination in 91 healthy volunteers reported increased willingness to be vaccinated with MNP by 1.33-fold (range 1.03–1.64), comparing with non-MNP vaccine acceptance in the US [12]. The adverse event rate of IM vaccine (6.12%) was retrieved from a randomized clinical trial (N = 4,348) that evaluated the immunogenicity and adverse events of inactivated quadrivalent influenza vaccine in children [13]. A meta-analysis (6 clinical studies for 673 adult subjects) reporting no significant differences in the occurrence of adverse events with intradermal and IM influenza vaccines [14].…”

Section: Methodsmentioning

confidence: 99%

Potential Cost-Effectiveness of an Influenza Vaccination Program Offering Microneedle Patch for Vaccine Delivery in Children

2016

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ObjectiveThe influenza vaccine coverage rate of children is low in Hong Kong. Microneedle patches (MNPs) is a technology under development for painless delivery of vaccines. This study aimed to examine the potential clinical outcomes and direct medical costs of an influenza program offering MNP vaccine to children who have declined intramuscular (IM) vaccine in Hong Kong.MethodsA decision model was designed to compare potential outcomes between IM vaccine program and a program offering MNP vaccine to those declined IM vaccine (IM/MNP program) in a hypothetical cohort of children over one-year time horizon. The model outcomes included direct medical cost, influenza infection rate, mortality rate, and quality-adjusted life-years (QALYs) loss. Model inputs were retrieved from published literature. Sensitivity analyses were performed to examine the robustness of model results.ResultsIn base-case analysis, IM/MNP program was more costly per child (USD19.13 versus USD13.69; USD1 = HKD7.8) with lower influenza infection rate (98.9 versus 124.8 per 1,000 children), hospitalization rate (0.83 versus 1.05 per 1,000 children) and influenza-related mortality rate (0.00042 versus 0.00052 per 1,000 children) when compared to IM program. The incremental cost per QALY saved (ICER) of IM/MNP program versus IM program was 27,200 USD/QALY. Using gross domestic product (GDP) per capita of Hong Kong (USD40,594) as threshold of willingness-to-pay (WTP) per QALY, one-way sensitivity analysis found ICER of IM/MNP to exceed WTP when duration of illness in outpatient setting was <5.7 days or cost per MNP vaccine was >1.39-time of IM vaccine cost. In 10,000 Monte Carlo simulations, IM/MNP program was the preferred option in 57.28% and 91.68% of the time, using 1x and 3x GDP per capita as WTP threshold, respectively.ConclusionAcceptance of IM/MNP program as the preferred program was subject to the WTP threshold, duration of illness in outpatient settings, and cost of MNP vaccine.

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Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age

Cited by 42 publications

References 18 publications

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6–35 Months of Age During 2013–2014: Results From A Phase II Randomized Trial

Prevention and Control of Seasonal Influenza with Vaccines

Potential Cost-Effectiveness of an Influenza Vaccination Program Offering Microneedle Patch for Vaccine Delivery in Children

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