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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

Incidence and nature of local injection-site adverse events on days 0 to 6 after each vaccine dose in the TVC. Grade 3 pain was defined as a child crying when his or her limb was moved and/or spontaneously painful; grade 3, redness/swelling of >100 mm. Error bars indicate 95% CIs.
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PIU098F4: Incidence and nature of local injection-site adverse events on days 0 to 6 after each vaccine dose in the TVC. Grade 3 pain was defined as a child crying when his or her limb was moved and/or spontaneously painful; grade 3, redness/swelling of >100 mm. Error bars indicate 95% CIs.

Mentions: The frequencies of injection-site and general solicited AEs overall during the 7 days after vaccination are shown in Figures 4 and 5. Injection-site pain was the most frequently reported solicited injection-site AE (QIV, 32.6%; TIV, 30.6%), with grade 3 pain in 2.4% and 1.0% of participants, respectively. Irritability/fussiness was the most frequently reported solicited general AE (40.7% and 41.6% of subjects in the QIV and TIV groups, respectively). Grade 3 irritability/fussiness was reported in 5.2% and 4.7% of the QIV and TIV recipients, respectively.Figure 4.


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)

Incidence and nature of local injection-site adverse events on days 0 to 6 after each vaccine dose in the TVC. Grade 3 pain was defined as a child crying when his or her limb was moved and/or spontaneously painful; grade 3, redness/swelling of >100 mm. Error bars indicate 95% CIs.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

PIU098F4: Incidence and nature of local injection-site adverse events on days 0 to 6 after each vaccine dose in the TVC. Grade 3 pain was defined as a child crying when his or her limb was moved and/or spontaneously painful; grade 3, redness/swelling of >100 mm. Error bars indicate 95% CIs.
Mentions: The frequencies of injection-site and general solicited AEs overall during the 7 days after vaccination are shown in Figures 4 and 5. Injection-site pain was the most frequently reported solicited injection-site AE (QIV, 32.6%; TIV, 30.6%), with grade 3 pain in 2.4% and 1.0% of participants, respectively. Irritability/fussiness was the most frequently reported solicited general AE (40.7% and 41.6% of subjects in the QIV and TIV groups, respectively). Grade 3 irritability/fussiness was reported in 5.2% and 4.7% of the QIV and TIV recipients, respectively.Figure 4.

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