Efficacy of a Cell-Culture-Derived Quadrivalent Influenza Vaccine in Children.

Adolescent Antibodies, Viral / blood Child Child, Preschool Female Humans Immunogenicity, Vaccine Influenza Vaccines / adverse effects Influenza, Human / prevention & control Male Meningococcal Vaccines / immunology Orthomyxoviridae / isolation & purification Proportional Hazards Models Reverse Transcriptase Polymerase Chain Reaction Single-Blind Method Vaccines, Inactivated / immunology

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
14 10 2021
Historique:
entrez: 13 10 2021
pubmed: 14 10 2021
medline: 29 10 2021
Statut: ppublish

Résumé

Cell-culture-derived influenza vaccines may enable a closer antigenic match to circulating strains of influenza virus by avoiding egg-adapted mutations. We evaluated the efficacy of a cell-culture-derived quadrivalent inactivated influenza vaccine (IIV4c) using a Madin-Darby canine kidney cell line in children and adolescents 2 to less than 18 years of age. During three influenza seasons, participants from eight countries were enrolled in an observer-blinded, randomized clinical trial comparing IIV4c with a noninfluenza vaccine (meningococcal ACWY). All the participants received a dose of a trial vaccine. Children 2 to less than 9 years of age without previous influenza vaccination who were assigned to the IIV4c group received a second dose on day 29; their counterparts who were assigned to the comparator group received placebo. Participants were followed for at least 180 days for efficacy and safety. The presence of influenza virus in nasopharyngeal swabs from participants with influenza-like illness was confirmed by reverse-transcriptase-polymerase-chain-reaction assay and viral culture. A Cox proportional-hazards model was used to evaluate the efficacy of IIV4c as measured by the first occurrence of laboratory-confirmed type A or B influenza (primary end point). Between 2017 and 2019, a total of 4514 participants were randomly assigned to receive IIV4c or the meningococcal ACWY vaccine. Laboratory-confirmed influenza occurred in 175 of 2257 participants (7.8%) in the IIV4c group and in 364 of 2252 participants (16.2%) in the comparator group, and the efficacy of IIV4c was 54.6% (95% confidence interval [CI], 45.7 to 62.1). Efficacy was 80.7% (95% CI, 69.2 to 87.9) against influenza A/H1N1, 42.1% (95% CI, 20.3 to 57.9) against influenza A/H3N2, and 47.6% (95% CI, 31.4 to 60.0) against influenza B. IIV4c showed consistent vaccine efficacy in subgroups according to age, sex, race, and previous influenza vaccination. The incidences of adverse events were similar in the IIV4c group and the comparator group. IIV4c provided protection against influenza in healthy children and adolescents across seasons, regardless of previous influenza vaccination. (Funded by Seqirus; EudraCT number, 2016-002883-15; ClinicalTrials.gov number, NCT03165617.).

Sections du résumé

BACKGROUND
Cell-culture-derived influenza vaccines may enable a closer antigenic match to circulating strains of influenza virus by avoiding egg-adapted mutations.
METHODS
We evaluated the efficacy of a cell-culture-derived quadrivalent inactivated influenza vaccine (IIV4c) using a Madin-Darby canine kidney cell line in children and adolescents 2 to less than 18 years of age. During three influenza seasons, participants from eight countries were enrolled in an observer-blinded, randomized clinical trial comparing IIV4c with a noninfluenza vaccine (meningococcal ACWY). All the participants received a dose of a trial vaccine. Children 2 to less than 9 years of age without previous influenza vaccination who were assigned to the IIV4c group received a second dose on day 29; their counterparts who were assigned to the comparator group received placebo. Participants were followed for at least 180 days for efficacy and safety. The presence of influenza virus in nasopharyngeal swabs from participants with influenza-like illness was confirmed by reverse-transcriptase-polymerase-chain-reaction assay and viral culture. A Cox proportional-hazards model was used to evaluate the efficacy of IIV4c as measured by the first occurrence of laboratory-confirmed type A or B influenza (primary end point).
RESULTS
Between 2017 and 2019, a total of 4514 participants were randomly assigned to receive IIV4c or the meningococcal ACWY vaccine. Laboratory-confirmed influenza occurred in 175 of 2257 participants (7.8%) in the IIV4c group and in 364 of 2252 participants (16.2%) in the comparator group, and the efficacy of IIV4c was 54.6% (95% confidence interval [CI], 45.7 to 62.1). Efficacy was 80.7% (95% CI, 69.2 to 87.9) against influenza A/H1N1, 42.1% (95% CI, 20.3 to 57.9) against influenza A/H3N2, and 47.6% (95% CI, 31.4 to 60.0) against influenza B. IIV4c showed consistent vaccine efficacy in subgroups according to age, sex, race, and previous influenza vaccination. The incidences of adverse events were similar in the IIV4c group and the comparator group.
CONCLUSIONS
IIV4c provided protection against influenza in healthy children and adolescents across seasons, regardless of previous influenza vaccination. (Funded by Seqirus; EudraCT number, 2016-002883-15; ClinicalTrials.gov number, NCT03165617.).

Identifiants

DOI: 10.1056/NEJMoa2024848 PMID: 34644472
pubmed: 34644472
doi: 10.1056/NEJMoa2024848
doi:

Substances chimiques

Antibodies, Viral 0
Influenza Vaccines 0
Meningococcal Vaccines 0
Vaccines, Inactivated 0

Banques de données

EudraCT
['2016-002883-15']
ClinicalTrials.gov
['NCT03165617']

Types de publication

Clinical Trial, Phase III Clinical Trial, Phase IV Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1485-1495

Subventions

Organisme : Commonwealth Serum Laboratories
ID : N/A

Informations de copyright

Copyright © 2021 Massachusetts Medical Society.

Auteurs

Terence Nolan (T)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Alexandre C Fortanier (AC)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Brett Leav (B)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Airi Põder (A)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Lulu C Bravo (LC)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Henryk T Szymański (HT)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Marten Heeringa (M)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Wim Vermeulen (W)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Vince Matassa (V)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Igor Smolenov (I)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

Jonathan M Edelman (JM)

From the Murdoch Children's Research Institute and the Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne (T.N.), and Seqirus Clinical Development, Parkville (V.M.) - both in VIC, Australia; Seqirus Clinical Development, Amsterdam (A.C.F., M.H., W.V.); Seqirus Clinical Development, Cambridge, MA (B.L., I.S., J.M.E.); the Clinical Research Center, Tartu, Estonia (A.P.); the University of the Philippines, Manila (L.C.B.); and Hedwig of Silesia Hospital, Trzebnica, Poland (H.T.S.).

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adolescent › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Globulines › Sérum-globulines › Immunoglobulines › Anticorps › Anticorps antiviraux › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Personnes › Tranches d'âge › Enfant › Enfant d'âge préscolaire › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Phénomènes du système immunitaire › Immunogénicité des vaccins › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins antigrippaux › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Grippe humaine › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antibactériens › Vaccins antiméningococciques › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Virus › Virus à ARN › Virus à ARN de polarité négative › Orthomyxoviridae › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Analyse de survie › Modèles des risques proportionnels › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Techniques d'amplification d'acides nucléiques › Réaction de polymérisation en chaîne › RT-PCR › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en simple aveugle › Efficacy of a Cell-Culture-Derived...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins inactivés › Efficacy of a Cell-Culture-Derived...