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Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults.
Vaccine. 2013 Nov 12; 31(47):5572-8.V

Abstract

BACKGROUND AND AIMS

Although two antigenically distinct B strain lineages of influenza have co-circulated globally since the mid-1980s, trivalent influenza vaccines (TIVs) contain only one, resulting in frequent mismatches. This study examined the safety and immunogenicity of an inactivated quadrivalent influenza vaccine (QIV) candidate.

METHODS

This was a phase III, randomized, active-controlled, multicenter trial in adults during the 2011/2012 influenza season. Enrollment was stratified to include equal numbers of subjects 18-60 and >60 years of age. Subjects were randomized 5:1:1 to be vaccinated with the QIV, the licensed TIV, or an investigational TIV containing the alternate B strain lineage. Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination.

RESULTS

1116 subjects were vaccinated with QIV, 226 with the licensed TIV, and 223 with the investigational TIV. For all four vaccine strains, antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. For both B strains, post-vaccination antibody responses to the QIV were superior to the responses to the TIVs lacking the corresponding B strain. The QIV met all European Medicines Agency criteria for all four vaccine strains. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for the QIV and pooled TIV groups. The most commonly reported solicited reactions were injection-site pain, headache, and myalgia, and most solicited reactions were mild or moderate and appeared and resolved within 3 days of vaccination. No treatment-related serious adverse events or deaths were reported.

CONCLUSIONS

The inactivated QIV was well tolerated without any safety concerns. For all four vaccine strains, antibody responses to the QIV were superior to the responses to TIV for the unmatched strains and non-inferior for the matched strains. QIV could therefore help address an unmet need due to mismatched B strains in previous influenza vaccines.

CLINICAL TRIAL REGISTRY NUMBER

EudraCT: 2011-001976-21.

Authors+Show Affiliations

Sanofi Pasteur, Lyon, France. Electronic address: stephanie.pepin@sanofipasteur.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24016810

Citation

Pépin, Stéphanie, et al. "Safety and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine in Adults." Vaccine, vol. 31, no. 47, 2013, pp. 5572-8.
Pépin S, Donazzolo Y, Jambrecina A, et al. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine. 2013;31(47):5572-8.
Pépin, S., Donazzolo, Y., Jambrecina, A., Salamand, C., & Saville, M. (2013). Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine, 31(47), 5572-8. https://doi.org/10.1016/j.vaccine.2013.08.069
Pépin S, et al. Safety and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine in Adults. Vaccine. 2013 Nov 12;31(47):5572-8. PubMed PMID: 24016810.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. AU - Pépin,Stéphanie, AU - Donazzolo,Yves, AU - Jambrecina,Alen, AU - Salamand,Camille, AU - Saville,Melanie, Y1 - 2013/09/07/ PY - 2013/05/27/received PY - 2013/08/07/revised PY - 2013/08/19/accepted PY - 2013/9/11/entrez PY - 2013/9/11/pubmed PY - 2014/6/7/medline KW - Immunogenicity KW - Influenza KW - Quadrivalent KW - Safety KW - Trivalent KW - Vaccine SP - 5572 EP - 8 JF - Vaccine JO - Vaccine VL - 31 IS - 47 N2 - BACKGROUND AND AIMS: Although two antigenically distinct B strain lineages of influenza have co-circulated globally since the mid-1980s, trivalent influenza vaccines (TIVs) contain only one, resulting in frequent mismatches. This study examined the safety and immunogenicity of an inactivated quadrivalent influenza vaccine (QIV) candidate. METHODS: This was a phase III, randomized, active-controlled, multicenter trial in adults during the 2011/2012 influenza season. Enrollment was stratified to include equal numbers of subjects 18-60 and >60 years of age. Subjects were randomized 5:1:1 to be vaccinated with the QIV, the licensed TIV, or an investigational TIV containing the alternate B strain lineage. Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination. RESULTS: 1116 subjects were vaccinated with QIV, 226 with the licensed TIV, and 223 with the investigational TIV. For all four vaccine strains, antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. For both B strains, post-vaccination antibody responses to the QIV were superior to the responses to the TIVs lacking the corresponding B strain. The QIV met all European Medicines Agency criteria for all four vaccine strains. Solicited reactions, unsolicited adverse events, and serious adverse events were similar for the QIV and pooled TIV groups. The most commonly reported solicited reactions were injection-site pain, headache, and myalgia, and most solicited reactions were mild or moderate and appeared and resolved within 3 days of vaccination. No treatment-related serious adverse events or deaths were reported. CONCLUSIONS: The inactivated QIV was well tolerated without any safety concerns. For all four vaccine strains, antibody responses to the QIV were superior to the responses to TIV for the unmatched strains and non-inferior for the matched strains. QIV could therefore help address an unmet need due to mismatched B strains in previous influenza vaccines. CLINICAL TRIAL REGISTRY NUMBER: EudraCT: 2011-001976-21. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/24016810/Safety_and_immunogenicity_of_a_quadrivalent_inactivated_influenza_vaccine_in_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(13)01181-X DB - PRIME DP - Unbound Medicine ER -