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Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.

Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK - J Pediatric Infect Dis Soc (2014)

Bottom Line: The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%.Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.

View Article: PubMed Central - PubMed

Affiliation: Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.

ABSTRACT

Background: Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.

Methods: In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.

Results: Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.

Conclusions: In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.

No MeSH data available.


Related in: MedlinePlus

Participant flow. Abbreviations: QIV, quadrivalent influenza vaccine; TIV-YB, trivalent influenza vaccine containing Yamagata lineage of the B strain.
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PIU098F1: Participant flow. Abbreviations: QIV, quadrivalent influenza vaccine; TIV-YB, trivalent influenza vaccine containing Yamagata lineage of the B strain.

Mentions: This study was a randomized (1:1) controlled double-blind comparison of QIV and TIV in 6- to 35-month-old children to determine safety and immunogenicity (Figure 1). The study was initiated on November 1, 2012, and the day 180 visit concluded on June 19, 2013.Figure 1.


Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.

Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK - J Pediatric Infect Dis Soc (2014)

Participant flow. Abbreviations: QIV, quadrivalent influenza vaccine; TIV-YB, trivalent influenza vaccine containing Yamagata lineage of the B strain.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4554197&req=5

PIU098F1: Participant flow. Abbreviations: QIV, quadrivalent influenza vaccine; TIV-YB, trivalent influenza vaccine containing Yamagata lineage of the B strain.
Mentions: This study was a randomized (1:1) controlled double-blind comparison of QIV and TIV in 6- to 35-month-old children to determine safety and immunogenicity (Figure 1). The study was initiated on November 1, 2012, and the day 180 visit concluded on June 19, 2013.Figure 1.

Bottom Line: The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%.Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.

View Article: PubMed Central - PubMed

Affiliation: Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.

ABSTRACT

Background: Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.

Methods: In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.

Results: Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.

Conclusions: In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.

No MeSH data available.


Related in: MedlinePlus