Format

Send to

Choose Destination
Pediatr Infect Dis J. 2014 Jun;33(6):630-6. doi: 10.1097/INF.0000000000000254.

Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age.

Author information

1
From the *Sanofi Pasteur, Swiftwater, PA; †Department of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA; ‡Senders Pediatrics, Cleveland, OH; and §Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN.

Abstract

BACKGROUND:

Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 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 United States among children 6 months to <9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with 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:

A total of 4363 participants were enrolled. QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding 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 2 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
DOI:
10.1097/INF.0000000000000254
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Wolters Kluwer
Loading ...
Support Center