tetano
Editor, Senior Moderator
Pediatr Infect Dis J. 2014 Jan 17. [Epub ahead of print]
Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age.
Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD.
Author information
Abstract
BACKGROUND::
Strains of two distinct influenza B lineages (Victoria and Yamagata) have co-circulated in the US for over a decade, but trivalent influenza vaccines (TIVs) contain only one B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season's TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
METHODS::
This was a Phase III, randomized, multicenter trial in the US among children 6 months to < 9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared to inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain, or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
RESULTS::
4363 participants were enrolled. QIV induced non-inferior antibody responses to all A strains and corresponding B strains compared to the control TIVs and superior antibody responses to the non-corresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
CONCLUSIONS::
This study demonstrated that QIV is safe and immunogenic among children 6 months to < 9 years of age. These findings, along with data from two other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.
PMID:
24445833
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24445833
Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months through 8 Years of Age.
Greenberg DP, Robertson CA, Landolfi VA, Bhaumik A, Senders SD, Decker MD.
Author information
Abstract
BACKGROUND::
Strains of two distinct influenza B lineages (Victoria and Yamagata) have co-circulated in the US for over a decade, but trivalent influenza vaccines (TIVs) contain only one B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season's TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
METHODS::
This was a Phase III, randomized, multicenter trial in the US among children 6 months to < 9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared to inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain, or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
RESULTS::
4363 participants were enrolled. QIV induced non-inferior antibody responses to all A strains and corresponding B strains compared to the control TIVs and superior antibody responses to the non-corresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
CONCLUSIONS::
This study demonstrated that QIV is safe and immunogenic among children 6 months to < 9 years of age. These findings, along with data from two other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.
PMID:
24445833
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24445833