Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults

Pépin, Stéphanie; Donazzolo, Yves; Jambrecina, Alen; Salamand, Camille; Saville, Mélanie

doi:10.1016/j.vaccine.2013.08.069

Cited by 87 publications

(84 citation statements)

References 18 publications

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“…HAI titres were measured at baseline (day 0) and 28 d after the last vaccination as described previously 4 . The lower limit of quantitation was set at the reciprocal of the lowest dilution used in the assay (10) and the upper limit of quantitation as the highest dilution used in the assay (10,240).…”

Section: Methodsmentioning

confidence: 99%

“…In children/adolescents aged 9 to 17 years, adults aged 18 to 60 years, and elderly adults, IIV4 was as immunogenic as the comparator trivalent inactivated influenza vaccine (IIV3) for each of the 3 shared influenza strains and superior for the additional B strain 4,5 . In all age groups, IIV4 has had a safety profile similar to that of the licensed IIV3, with no unexpected safety signals, 4,5 but its safety and efficacy in young children has not been described. Here, we describe the results of a phase III clinical trial to assess the immunogenicity and safety of this vaccine in children aged 3 to 8 y of age.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study

Pépin

Szymański²,

Kobashi³

et al. 2016

Human Vaccines & Immunotherapeutics

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A quadrivalent, inactivated, split-virion influenza vaccine containing a strain from both B lineages (IIV4) has been developed, but its safety and immunogenicity in young children has not been described. This was a phase III, randomized, double-blind, active-controlled, multi-center study to examine the immunogenicity and safety of IIV4 in children 3–8 y of age (EudraCT no. 2011-005374-33). Participants were randomized 5:1:1 to receive the 2013/2014 Northern Hemisphere formulation of IIV4, an investigational trivalent comparator (IIV3) containing the B/Victoria lineage strain, or the licensed Northern Hemisphere IIV3 containing the B/Yamagata lineage strain. Participants who had not previously received a full influenza vaccination schedule received 2 doses of vaccine 28 d apart; all others received a single dose. 1242 children were included. For all 4 strains, IIV4 induced geometric mean haemagglutination inhibition titres non-inferior to those induced by the IIV3 comparators. For both B strains, geometric mean antibody titres induced by IIV4 were superior to those induced by the IIV3 with the alternative lineage strain. Similar proportions of participants vaccinated with IIV4 and IIV3 reported solicited injection-site reactions, solicited systemic reactions, and vaccine-related adverse events. A single vaccine-related serious adverse event, thrombocytopenia, was reported 9 d after vaccination with IIV4 and resolved without sequelae. In conclusion, in children aged 3–8 y who received one dose or 2 doses 28 d apart, IIV4 had an acceptable safety profile, was as immunogenic as IIV3 for the shared strains, and had superior immunogenicity for the additional B strain.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and immunogenicity of an intramuscular quadrivalent influenza vaccine in children 3 to 8 y of age: A phase III randomized controlled study

Pépin

Szymański²,

Kobashi³

et al. 2016

Human Vaccines & Immunotherapeutics

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show abstract

“…Among adults the most common safety complaints were injection-site pain and systemic reactions, such as myalgia, headaches, and fatigue (123,125,127,129,130,309). The first postlicensure safety assessment of VAERS reports covering the 2013-14 and 2014-15 seasons noted a safety profile similar to that of IIV3.…”

Section: Adultsmentioning

confidence: 99%

Prevention and Control of Seasonal Influenza with Vaccines

Grohskopf

Sokolow²,

Broder³

et al. 2016

MMWR Recomm. Rep.

383

279

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“…33 34 Newer quadrivalent vaccines are being increasingly adopted due to the broader protection provided by the inclusion of an additional influenza B virus. [35][36][37][38] Since 2013, the UK influenza vaccination programme has been extended to children aged 2-4 years, with planned phased introduction to children of school ages, 23 as it reduces morbidity by directly protecting children and provides indirect protection to vulnerable groups (such as grandparents) by reducing transmission in the community. 39 40 Attenuated live nasal spray formulation is recommended in children aged 2-<17 years based on its superior efficacy and greater immunity against mismatched strains compared with inactivated vaccines.…”

Section: How Can Influenza Be Prevented? Vaccinationmentioning

confidence: 99%