Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults
Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs), to enhance protection against...
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| Format: | Article |
| Language: | English |
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MDPI AG
2018-03-01
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| Series: | Vaccines |
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| Online Access: | http://www.mdpi.com/2076-393X/6/1/14 |
| _version_ | 1818013449197715456 |
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| author | Emanuele Montomoli Alessandro Torelli Ilaria Manini Elena Gianchecchi |
| author_facet | Emanuele Montomoli Alessandro Torelli Ilaria Manini Elena Gianchecchi |
| author_sort | Emanuele Montomoli |
| collection | DOAJ |
| description | Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs), to enhance protection against circulating influenza B viruses. This review describes the results obtained from seven phase III clinical trials evaluating the immunogenicity, safety, and lot-to-lot consistency of a new quadrivalent split-virion influenza vaccine (Vaxigrip Tetra®) formulated by adding a second B strain to the already licensed TIV. Since Vaxigrip Tetra was developed by means of a manufacturing process strictly related to that used for TIV, the data on the safety profile of TIV are considered supportive of that of Vaxigrip Tetra. The safety and immunogenicity of Vaxigrip Tetra were similar to those of the corresponding licensed TIV. Moreover, the new vaccine elicits a superior immune response towards the additional strain, without affecting immunogenicity towards the other three strains. Vaxigrip Tetra is well tolerated, has aroused no safety concerns, and is recommended for the active immunization of individuals aged ≥6 months. In addition, preliminary data confirm its immunogenicity and safety even in children aged 6–35 months and its immunogenicity in older subjects (aged 66–80 years). |
| first_indexed | 2024-04-14T06:33:16Z |
| format | Article |
| id | doaj.art-1c3c7abe4bba4f1581a17e4ff8006903 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-04-14T06:33:16Z |
| publishDate | 2018-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-1c3c7abe4bba4f1581a17e4ff80069032022-12-22T02:07:32ZengMDPI AGVaccines2076-393X2018-03-01611410.3390/vaccines6010014vaccines6010014Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older AdultsEmanuele Montomoli0Alessandro Torelli1Ilaria Manini2Elena Gianchecchi3VisMederi srl, Strada del Petriccio e Belriguardo, 35, 53100 Siena, ItalyVisMederi srl, Strada del Petriccio e Belriguardo, 35, 53100 Siena, ItalyDepartment of Molecular and Developmental Medicine, University of Siena, 53100 Siena, ItalyVisMederi srl, Strada del Petriccio e Belriguardo, 35, 53100 Siena, ItalySince the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has prompted efforts to formulate quadrivalent influenza vaccines (QIVs), to enhance protection against circulating influenza B viruses. This review describes the results obtained from seven phase III clinical trials evaluating the immunogenicity, safety, and lot-to-lot consistency of a new quadrivalent split-virion influenza vaccine (Vaxigrip Tetra®) formulated by adding a second B strain to the already licensed TIV. Since Vaxigrip Tetra was developed by means of a manufacturing process strictly related to that used for TIV, the data on the safety profile of TIV are considered supportive of that of Vaxigrip Tetra. The safety and immunogenicity of Vaxigrip Tetra were similar to those of the corresponding licensed TIV. Moreover, the new vaccine elicits a superior immune response towards the additional strain, without affecting immunogenicity towards the other three strains. Vaxigrip Tetra is well tolerated, has aroused no safety concerns, and is recommended for the active immunization of individuals aged ≥6 months. In addition, preliminary data confirm its immunogenicity and safety even in children aged 6–35 months and its immunogenicity in older subjects (aged 66–80 years).http://www.mdpi.com/2076-393X/6/1/14Vaxigrip TetraInfluenzaInfluenza vaccines |
| spellingShingle | Emanuele Montomoli Alessandro Torelli Ilaria Manini Elena Gianchecchi Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults Vaccines Vaxigrip Tetra Influenza Influenza vaccines |
| title | Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults |
| title_full | Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults |
| title_fullStr | Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults |
| title_full_unstemmed | Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults |
| title_short | Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults |
| title_sort | immunogenicity and safety of the new inactivated quadrivalent influenza vaccine vaxigrip tetra preliminary results in children ≥6 months and older adults |
| topic | Vaxigrip Tetra Influenza Influenza vaccines |
| url | http://www.mdpi.com/2076-393X/6/1/14 |
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