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Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.
J Infect Dis. 2013 Aug 15; 208(4):544-53.JI

Abstract

BACKGROUND

Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently.

METHODS

In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age.

RESULTS

A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam).

CONCLUSION

QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs.

CLINICAL TRIALS REGISTRATION

NCT01198756.

Authors+Show Affiliations

Canadian Center for Vaccinology, Dalhousie University and the IWK Health Centre, Halifax, Nova Scotia, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23847058

Citation

Langley, Joanne M., et al. "Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: a Phase III Randomized Controlled Trial in Children." The Journal of Infectious Diseases, vol. 208, no. 4, 2013, pp. 544-53.
Langley JM, Carmona Martinez A, Chatterjee A, et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. J Infect Dis. 2013;208(4):544-53.
Langley, J. M., Carmona Martinez, A., Chatterjee, A., Halperin, S. A., McNeil, S., Reisinger, K. S., Aggarwal, N., Huang, L. M., Peng, C. T., Garcia-Sicilia, J., Salamanca de la Cueva, I., Cabañas, F., Treviño-Garza, C., Rodríguez-Weber, M. A., de la O, M., Chandrasekaran, V., Dewé, W., Liu, A., Innis, B. L., & Jain, V. K. (2013). Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. The Journal of Infectious Diseases, 208(4), 544-53. https://doi.org/10.1093/infdis/jit263
Langley JM, et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate: a Phase III Randomized Controlled Trial in Children. J Infect Dis. 2013 Aug 15;208(4):544-53. PubMed PMID: 23847058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children. AU - Langley,Joanne M, AU - Carmona Martinez,Alfonso, AU - Chatterjee,Archana, AU - Halperin,Scott A, AU - McNeil,Shelly, AU - Reisinger,Keith S, AU - Aggarwal,Naresh, AU - Huang,Li-Min, AU - Peng,Ching-Tien, AU - Garcia-Sicilia,José, AU - Salamanca de la Cueva,Ignacio, AU - Cabañas,Fernando, AU - Treviño-Garza,Consuelo, AU - Rodríguez-Weber,Miguel Angel, AU - de la O,Manuel, AU - Chandrasekaran,Vijayalakshmi, AU - Dewé,Walthère, AU - Liu,Aixue, AU - Innis,Bruce L, AU - Jain,Varsha K, Y1 - 2013/07/11/ PY - 2013/7/13/entrez PY - 2013/7/13/pubmed PY - 2013/10/1/medline KW - children KW - immunogenicity KW - influenza vaccine SP - 544 EP - 53 JF - The Journal of infectious diseases JO - J. Infect. Dis. VL - 208 IS - 4 N2 - BACKGROUND: Mismatch between circulating influenza B viruses (Yamagata and Victoria lineages) and vaccine strains occurs frequently. METHODS: In a randomized controlled trial, immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate (QIV) versus trivalent inactivated influenza vaccine (TIV)-Victoria(Vic) and TIV-Yamagata(Yam) in children 3-17 years of age was evaluated. In an open-label study arm, QIV only was assessed in children 6-35 months of age. RESULTS: A total of 3094 children (932 QIV, 929 TIV-Vic, 932 TIV-Yam, and 301 QIV only) were vaccinated. QIV was noninferior to the TIVs for shared strains (A/H3N2 and A/H1N1) based on hemagglutination-inhibition (HI) antibodies 28 days after last vaccination, and superior for the unique B strains Victoria and Yamagata (geometric mean titer ratios 2.61, 3.78; seroconversion rate differences 33.96%, 44.63%). Among children in the randomized trial, adverse event rates were similar except for injection site pain (dose 1: 65.4% QIV, 54.6% TIV-Vic, 55.7% TIV-Yam). CONCLUSION: QIV elicited superior HI responses to the added B strains compared to TIV controls, potentially improving its effectiveness against influenza B. HI responses were similar between QIV and TIV controls for the shared strains. QIV had an acceptable safety profile relative to TIVs. CLINICAL TRIALS REGISTRATION: NCT01198756. SN - 1537-6613 UR - https://www.unboundmedicine.com/medline/citation/23847058/Immunogenicity_and_safety_of_an_inactivated_quadrivalent_influenza_vaccine_candidate:_a_phase_III_randomized_controlled_trial_in_children_ L2 - https://academic.oup.com/jid/article-lookup/doi/10.1093/infdis/jit263 DB - PRIME DP - Unbound Medicine ER -