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Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age.
Pediatr Infect Dis J. 2014 Jun; 33(6):630-6.PI

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.

Authors+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24445833

Citation

Greenberg, David P., et al. "Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months Through 8 Years of Age." The Pediatric Infectious Disease Journal, vol. 33, no. 6, 2014, pp. 630-6.
Greenberg DP, Robertson CA, Landolfi VA, et al. Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. Pediatr Infect Dis J. 2014;33(6):630-6.
Greenberg, D. P., Robertson, C. A., Landolfi, V. A., Bhaumik, A., Senders, S. D., & Decker, M. D. (2014). Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. The Pediatric Infectious Disease Journal, 33(6), 630-6. https://doi.org/10.1097/INF.0000000000000254
Greenberg DP, et al. Safety and Immunogenicity of an Inactivated Quadrivalent Influenza Vaccine in Children 6 Months Through 8 Years of Age. Pediatr Infect Dis J. 2014;33(6):630-6. PubMed PMID: 24445833.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of an inactivated quadrivalent influenza vaccine in children 6 months through 8 years of age. AU - Greenberg,David P, AU - Robertson,Corwin A, AU - Landolfi,Victoria A, AU - Bhaumik,Amitabha, AU - Senders,Shelly D, AU - Decker,Michael D, PY - 2014/1/22/entrez PY - 2014/1/22/pubmed PY - 2015/2/24/medline SP - 630 EP - 6 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 33 IS - 6 N2 - 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/24445833/Safety_and_immunogenicity_of_an_inactivated_quadrivalent_influenza_vaccine_in_children_6_months_through_8_years_of_age_ L2 - http://dx.doi.org/10.1097/INF.0000000000000254 DB - PRIME DP - Unbound Medicine ER -