tetano
Editor, Senior Moderator
J Infect Dis. (2013) doi: 10.1093/infdis/jit091
A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3?17 years
J.B. Domachowske1,
H. Pankow-Culot2,
M. Bautista3,
Y. Feng4,
C. Claeys4,
M. Peeters4,
B.L. Innis5 and
V. Jain5
1Department of Pediatrics, Golisano Children's Hospital, Upstate Medical University, Syracuse NY USA
2Pediatric Office, Heiligenhaus, Germany
3University of the East Ramon Magsaysay Memorial Medical Center Inc., Quezon City, Philippines
4GlaxoSmithKline Vaccines, Wavre, Belgium
5GlaxoSmithKline Vaccines, King of Prussia, PA, USA
Corresponding Author: Dr. Joseph Domachowske MD, Address: Upstate Medical University, Department of Pediatrics, 750 East Adams Street, Syracuse, NY 13210, Tel: +001-315-464-7577, Fax: +001-315-464-7564, E-mail: domachoj{at}upstate.edu
Abstract
Background. Two antigenically distinct influenza B lineages have co-circulated since 2001, yet trivalent influenza vaccines (TIV) contain one influenza B antigen, meaning lineage-mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy children aged 3?17 years.
Methods. Children were randomized 1:1:1 to receive QIV or one of two TIVs (either B/Victoria or B/Yamagata lineage) (N=2738). Hemagglutination-inhibition assays were performed 28-days after one or two doses in primed and unprimed children, respectively. Immunological non-inferiority of QIV versus TIV against shared strains, and superiority against alternate-lineage B strains was based on GMTs and seroconversion rates. Reactogenicity and safety were also assessed. NCT01196988
Results. Non-inferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV versus TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.
Conclusions. QIV versus TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines.
http://jid.oxfordjournals.org/content/early/2013/03/06/infdis.jit091.abstract
A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3?17 years
J.B. Domachowske1,
H. Pankow-Culot2,
M. Bautista3,
Y. Feng4,
C. Claeys4,
M. Peeters4,
B.L. Innis5 and
V. Jain5
1Department of Pediatrics, Golisano Children's Hospital, Upstate Medical University, Syracuse NY USA
2Pediatric Office, Heiligenhaus, Germany
3University of the East Ramon Magsaysay Memorial Medical Center Inc., Quezon City, Philippines
4GlaxoSmithKline Vaccines, Wavre, Belgium
5GlaxoSmithKline Vaccines, King of Prussia, PA, USA
Corresponding Author: Dr. Joseph Domachowske MD, Address: Upstate Medical University, Department of Pediatrics, 750 East Adams Street, Syracuse, NY 13210, Tel: +001-315-464-7577, Fax: +001-315-464-7564, E-mail: domachoj{at}upstate.edu
Abstract
Background. Two antigenically distinct influenza B lineages have co-circulated since 2001, yet trivalent influenza vaccines (TIV) contain one influenza B antigen, meaning lineage-mismatch with the vaccine is frequent. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy children aged 3?17 years.
Methods. Children were randomized 1:1:1 to receive QIV or one of two TIVs (either B/Victoria or B/Yamagata lineage) (N=2738). Hemagglutination-inhibition assays were performed 28-days after one or two doses in primed and unprimed children, respectively. Immunological non-inferiority of QIV versus TIV against shared strains, and superiority against alternate-lineage B strains was based on GMTs and seroconversion rates. Reactogenicity and safety were also assessed. NCT01196988
Results. Non-inferiority against shared strains and superiority against alternate-lineage B strains was demonstrated for QIV versus TIV. QIV was highly immunogenic; seroconversion rates were 91.4%, 72.3%, 70.0%, and 72.5% against A/H1N1, A/H3N2, B/Victoria, and B/Yamagata, respectively. Reactogenicity and safety of QIV was consistent with TIV.
Conclusions. QIV versus TIV showed superior immunogenicity for the additional B strain without interfering with immune responses to shared strains. QIV may offer improved protection against influenza B in children compared with current trivalent vaccines.
http://jid.oxfordjournals.org/content/early/2013/03/06/infdis.jit091.abstract