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Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.
J Pediatric Infect Dis Soc. 2016 Jun; 5(2):170-9.JP

Abstract

BACKGROUND

Viruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection.

METHODS

We compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6-35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314).

RESULTS

Seroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%-86.6%), 72.0% (95% CI, 63.9%-79.2%), 86.0% (95% CI, 79.2%-91.2%), and 66.4% (95% CI, 58.1%-74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%-5.99%) and SCR difference of 54.02% (95% CI, 43.88%-62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination.

CONCLUSIONS

Quadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6-35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group.

Authors+Show Affiliations

GSK Vaccines, Vaccine Discovery and Development, King of Prussia, Pennsylvania.GSK Vaccines, Biostatistics, King of Prussia, Pennsylvania.SUNY Upstate Medical Center, Syracuse, New York.GSK Vaccines, Biostatistics, King of Prussia, Pennsylvania.GSK Vaccines, Vaccine Discovery and Development, King of Prussia, Pennsylvania.GSK Vaccines, Vaccine Discovery and Development, King of Prussia, Pennsylvania.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26407273

Citation

Wang, Long, et al. "Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From a Phase II Randomized Trial." Journal of the Pediatric Infectious Diseases Society, vol. 5, no. 2, 2016, pp. 170-9.
Wang L, Chandrasekaran V, Domachowske JB, et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial. J Pediatric Infect Dis Soc. 2016;5(2):170-9.
Wang, L., Chandrasekaran, V., Domachowske, J. B., Li, P., Innis, B. L., & Jain, V. K. (2016). Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial. Journal of the Pediatric Infectious Diseases Society, 5(2), 170-9. https://doi.org/10.1093/jpids/piv041
Wang L, et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From a Phase II Randomized Trial. J Pediatric Infect Dis Soc. 2016;5(2):170-9. PubMed PMID: 26407273.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial. AU - Wang,Long, AU - Chandrasekaran,Vijayalakshmi, AU - Domachowske,Joseph B, AU - Li,Ping, AU - Innis,Bruce L, AU - Jain,Varsha K, Y1 - 2015/07/16/ PY - 2015/02/13/received PY - 2015/06/09/accepted PY - 2015/9/26/entrez PY - 2015/9/26/pubmed PY - 2018/4/24/medline KW - children KW - immunogenicity KW - influenza KW - quadrivalent KW - vaccine SP - 170 EP - 9 JF - Journal of the Pediatric Infectious Diseases Society JO - J Pediatric Infect Dis Soc VL - 5 IS - 2 N2 - BACKGROUND: Viruses from 2 influenza B lineages co-circulate, leading to suboptimal protection with trivalent influenza vaccines (TIV). Quadrivalent influenza vaccines (QIV) containing both lineages offer broader protection. METHODS: We compared inactivated seasonal QIV versus TIV (15 and 7.5 μg hemagglutinin [HA] for each influenza strain, respectively) in a phase II randomized (1 : 1), observer-blind trial in US children 6-35 months of age (identifier NCT01974895). The primary objective was to evaluate immune responses induced by QIV for the 4 vaccine strains 28 days after completion of vaccination. A secondary objective was to demonstrate superiority of QIV versus TIV for the B/Victoria strain contained in QIV but not TIV. Immunogenicity was evaluated in the per-protocol cohort (N = 280), and safety was evaluated in the intent-to-treat cohort (N = 314). RESULTS: Seroconversion rates (SCRs) for QIV were 80.4% (95% confidence interval [CI], 73.0%-86.6%), 72.0% (95% CI, 63.9%-79.2%), 86.0% (95% CI, 79.2%-91.2%), and 66.4% (95% CI, 58.1%-74.1%) for A/H1N1, A/H3N2, B/Yamagata, and B/Victoria, respectively. Quadrivalent influenza vaccines demonstrated immunogenic superiority over TIV for B/Victoria with a geometric mean titer ratio of 4.73 (95% CI, 3.73%-5.99%) and SCR difference of 54.02% (95% CI, 43.88%-62.87%). Safety was similar between the vaccine groups despite the QIV's higher antigen content. No serious adverse events were reported related to vaccination. CONCLUSIONS: Quadrivalent influenza vaccine (15 µg HA/strain) was immunogenic with an acceptable safety profile. The next phase of its development in children 6-35 months of age is a phase III trial in countries where it is not yet licensed. In countries where it is already licensed, a switch from TIV to QIV would provide broader protection in this vulnerable group. SN - 2048-7207 UR - https://www.unboundmedicine.com/medline/citation/26407273/Immunogenicity_and_Safety_of_an_Inactivated_Quadrivalent_Influenza_Vaccine_in_US_Children_6_35_Months_of_Age_During_2013_2014:_Results_From_A_Phase_II_Randomized_Trial_ L2 - https://academic.oup.com/jpids/article-lookup/doi/10.1093/jpids/piv041 DB - PRIME DP - Unbound Medicine ER -