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A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses.
Vaccine. 2018 09 25; 36(40):6030-6038.V

Abstract

BACKGROUND

Trivalent influenza vaccines (TIVs) offer substantial protection against matching B-strains, however, protection against alternate-lineage B-strains may be enhanced by adding a second B-strain in quadrivalent influenza vaccines (QIVs). In this Phase III, double-blind, multicentre, randomised study, the immunogenicity and safety of subunit inactivated QIV versus TIV was assessed in adult (aged ≥18 to ≤60 years) and elderly (aged ≥61 years) subjects by analysing a combination of haemagglutinin inhibition (HI) and virus neutralisation (VN).

METHODS

Subjects (n = 1980) were recruited off season (2015/2016) from 20 centres in five European countries and randomised to receive either QIV (n = 1538), TIV with B-strain of the Victoria lineage (n = 221) or TIV with B-strain of the Yamagata lineage (n = 221). The primary aim was to demonstrate non-inferiority of QIV to TIV for immunogenicity against matched influenza strains based on post-vaccination HI titres. Secondary aims were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains and to characterise the immune response by reverse cumulative distribution (RCD) curves of antibody titres and derived serological parameters for HI and VN. Reactogenicity and occurrence of adverse events were assessed post-vaccination.

RESULTS

QIV elicited a non-inferior immune response for matched strains (upper limit of 95% CI for HI geometric mean ratios [GMRs] <1.5) and a superior response for alternate-lineage B-strains (HI GMRs < 1; p < 0.0001) versus TIV. RCD curves demonstrated that post-vaccination HI and VN titres were higher for QIV versus TIV for both alternate-lineage B-strains. Seroconversion rates and geometric mean fold increases of the VN assay were consistent with the HI assay for all strains in QIV. Reporting rates of local and systemic reactions were similar in both vaccine groups.

CONCLUSIONS

QIV was non-inferior in immunogenicity to TIV for matched strains and superior to the alternate-lineage B-strains in TIV. Safety and tolerability profiles of QIV and TIV were comparable.

Authors+Show Affiliations

Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, Netherlands. Electronic address: serge.vandewitte@abbott.com.Abbott Healthcare Products B.V., C.J. van Houtenlaan 36, 1381 CP Weesp, Netherlands.Department of Molecular and Developmental Medicine, University of Siena, Banchi di Sotto, 53100 Siena, Italy; VisMederi srl, Str. Del Petriccio e Belriguardo, 35, 53100 Siena, Italy.Medisch Centrum Tessenderlo, Groenstraat 27, 3980 Tessenderlo, Belgium.

Pub Type(s)

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

Language

eng

PubMed ID

29709447

Citation

van de Witte, Serge, et al. "A Phase III Randomised Trial of the Immunogenicity and Safety of Quadrivalent Versus Trivalent Inactivated Subunit Influenza Vaccine in Adult and Elderly Subjects, Assessing Both Anti-haemagglutinin and Virus Neutralisation Antibody Responses." Vaccine, vol. 36, no. 40, 2018, pp. 6030-6038.
van de Witte S, Nauta J, Montomoli E, et al. A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses. Vaccine. 2018;36(40):6030-6038.
van de Witte, S., Nauta, J., Montomoli, E., & Weckx, J. (2018). A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses. Vaccine, 36(40), 6030-6038. https://doi.org/10.1016/j.vaccine.2018.04.043
van de Witte S, et al. A Phase III Randomised Trial of the Immunogenicity and Safety of Quadrivalent Versus Trivalent Inactivated Subunit Influenza Vaccine in Adult and Elderly Subjects, Assessing Both Anti-haemagglutinin and Virus Neutralisation Antibody Responses. Vaccine. 2018 09 25;36(40):6030-6038. PubMed PMID: 29709447.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Phase III randomised trial of the immunogenicity and safety of quadrivalent versus trivalent inactivated subunit influenza vaccine in adult and elderly subjects, assessing both anti-haemagglutinin and virus neutralisation antibody responses. AU - van de Witte,Serge, AU - Nauta,Jos, AU - Montomoli,Emanuele, AU - Weckx,Jos, Y1 - 2018/04/27/ PY - 2018/01/18/received PY - 2018/04/16/revised PY - 2018/04/17/accepted PY - 2018/5/2/pubmed PY - 2019/2/15/medline PY - 2018/5/1/entrez KW - Immunogenicity KW - Influenza vaccine KW - Quadrivalent KW - Safety KW - Virus neutralisation SP - 6030 EP - 6038 JF - Vaccine JO - Vaccine VL - 36 IS - 40 N2 - BACKGROUND: Trivalent influenza vaccines (TIVs) offer substantial protection against matching B-strains, however, protection against alternate-lineage B-strains may be enhanced by adding a second B-strain in quadrivalent influenza vaccines (QIVs). In this Phase III, double-blind, multicentre, randomised study, the immunogenicity and safety of subunit inactivated QIV versus TIV was assessed in adult (aged ≥18 to ≤60 years) and elderly (aged ≥61 years) subjects by analysing a combination of haemagglutinin inhibition (HI) and virus neutralisation (VN). METHODS: Subjects (n = 1980) were recruited off season (2015/2016) from 20 centres in five European countries and randomised to receive either QIV (n = 1538), TIV with B-strain of the Victoria lineage (n = 221) or TIV with B-strain of the Yamagata lineage (n = 221). The primary aim was to demonstrate non-inferiority of QIV to TIV for immunogenicity against matched influenza strains based on post-vaccination HI titres. Secondary aims were to show superiority of QIV to TIV for immunogenicity against alternate-lineage B-strains and to characterise the immune response by reverse cumulative distribution (RCD) curves of antibody titres and derived serological parameters for HI and VN. Reactogenicity and occurrence of adverse events were assessed post-vaccination. RESULTS: QIV elicited a non-inferior immune response for matched strains (upper limit of 95% CI for HI geometric mean ratios [GMRs] <1.5) and a superior response for alternate-lineage B-strains (HI GMRs < 1; p < 0.0001) versus TIV. RCD curves demonstrated that post-vaccination HI and VN titres were higher for QIV versus TIV for both alternate-lineage B-strains. Seroconversion rates and geometric mean fold increases of the VN assay were consistent with the HI assay for all strains in QIV. Reporting rates of local and systemic reactions were similar in both vaccine groups. CONCLUSIONS: QIV was non-inferior in immunogenicity to TIV for matched strains and superior to the alternate-lineage B-strains in TIV. Safety and tolerability profiles of QIV and TIV were comparable. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29709447/A_Phase_III_randomised_trial_of_the_immunogenicity_and_safety_of_quadrivalent_versus_trivalent_inactivated_subunit_influenza_vaccine_in_adult_and_elderly_subjects_assessing_both_anti_haemagglutinin_and_virus_neutralisation_antibody_responses_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)30538-3 DB - PRIME DP - Unbound Medicine ER -