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doi:10.1016/j.vaccine.2011.08.111 | How to Cite or Link Using DOI
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Trivalent and quadrivalent MF59-adjuvanted influenza vaccine in young children: A dose- and schedule-finding study
Giovanni Della Cioppaa, b, c, Corresponding Author Contact Information, E-mail The Corresponding Author, E-mail The Corresponding Author, Timo Vesikarid, Etienne Sokale, Kelly Linderta, b, c and Uwe Nicolaya, b, c
a Novartis Vaccines and Diagnostics, Siena, Italy
b Novartis Vaccines Clinical Serology Laboratory, Marburg, Germany
c Novartis Pharmaceutical Development, Cambridge, MA, USA
d University of Tampere Medical School, Tampere, Finland
e Universit? Catholique de Louvain, Cliniques Universitaires St. Luc, Bruxelles, Belgium
Received 14 April 2011;
revised 20 August 2011;
accepted 25 August 2011.
Available online 8 September 2011.
Abstract
Young children are at increased risk for influenza infections and related complications. The protection offered to children by conventional trivalent inactivated influenza vaccines (TIV) is suboptimal, due to poor immunogenicity and a higher exposure to infection and complications in this age group, particularly from influenza B strains. In this dose-ranging, factorial design trial, we report the safety and immunogenicity of different combinations of adjuvanted (ATIV) and non-adjuvanted trivalent (TIV) and quadrivalent (QIV) influenza vaccines in 480 healthy children 6 to <36 months of age.
The results show the second B strain added to TIV was immunogenic and did not affect immunogenicity of the other strains. The addition of MF59-adjuvant promoted robust immune responses with notable elevations in antibodies observed even after one dose. A dose?response relationship was observed between the antibody response and MF59 adjuvant. No patterns in safety and tolerability emerged with different adjuvant and antigen doses nor with the addition of a second B strain. MF59-adjuvanted QIV offers potential advantages to young children.
Highlights
► This study confirms that the immunogenicity of nonadjuvanted influenza vaccines is suboptimal in 6?36 month-old children. ► Addition of MF59 adjuvant increased antibody responses to levels associated with protection in adults to an extent not achieved by nonadjuvanted vaccines and with no impact on reactogenicity and safety in these young children. ► A second influenza B strain combined with the traditional TIV vaccine is immunogenic and does not affect immunogenicity of the other three influenza strains. ► The MF59-adjuvanted TIV and QIV vaccines already show a meaningful immune response to influenza A strains after one dose, which may be beneficial in real-life clinical practice where a second dose is often missed, but the two-dose vaccination schedule must continue to be recommended in young children to provide protection against influenza B strains.
Permissions & Reprints
Trivalent and quadrivalent MF59-adjuvanted influenza vaccine in young children: A dose- and schedule-finding study
Giovanni Della Cioppaa, b, c, Corresponding Author Contact Information, E-mail The Corresponding Author, E-mail The Corresponding Author, Timo Vesikarid, Etienne Sokale, Kelly Linderta, b, c and Uwe Nicolaya, b, c
a Novartis Vaccines and Diagnostics, Siena, Italy
b Novartis Vaccines Clinical Serology Laboratory, Marburg, Germany
c Novartis Pharmaceutical Development, Cambridge, MA, USA
d University of Tampere Medical School, Tampere, Finland
e Universit? Catholique de Louvain, Cliniques Universitaires St. Luc, Bruxelles, Belgium
Received 14 April 2011;
revised 20 August 2011;
accepted 25 August 2011.
Available online 8 September 2011.
Abstract
Young children are at increased risk for influenza infections and related complications. The protection offered to children by conventional trivalent inactivated influenza vaccines (TIV) is suboptimal, due to poor immunogenicity and a higher exposure to infection and complications in this age group, particularly from influenza B strains. In this dose-ranging, factorial design trial, we report the safety and immunogenicity of different combinations of adjuvanted (ATIV) and non-adjuvanted trivalent (TIV) and quadrivalent (QIV) influenza vaccines in 480 healthy children 6 to <36 months of age.
The results show the second B strain added to TIV was immunogenic and did not affect immunogenicity of the other strains. The addition of MF59-adjuvant promoted robust immune responses with notable elevations in antibodies observed even after one dose. A dose?response relationship was observed between the antibody response and MF59 adjuvant. No patterns in safety and tolerability emerged with different adjuvant and antigen doses nor with the addition of a second B strain. MF59-adjuvanted QIV offers potential advantages to young children.
Highlights
► This study confirms that the immunogenicity of nonadjuvanted influenza vaccines is suboptimal in 6?36 month-old children. ► Addition of MF59 adjuvant increased antibody responses to levels associated with protection in adults to an extent not achieved by nonadjuvanted vaccines and with no impact on reactogenicity and safety in these young children. ► A second influenza B strain combined with the traditional TIV vaccine is immunogenic and does not affect immunogenicity of the other three influenza strains. ► The MF59-adjuvanted TIV and QIV vaccines already show a meaningful immune response to influenza A strains after one dose, which may be beneficial in real-life clinical practice where a second dose is often missed, but the two-dose vaccination schedule must continue to be recommended in young children to provide protection against influenza B strains.
