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Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults.
BMC Infect Dis. 2013 May 20; 13:224.BI

Abstract

BACKGROUND

Two phylogenetic lineages of influenza B virus coexist and circulate in the human population (B/Yamagata and B/Victoria) but only one B-strain is included in each seasonal vaccine. Mismatch regularly occurs between the recommended and circulating B-strain. Inclusion of both lineages in vaccines may offer better protection against influenza.

METHODS

This study (NCT00714285) assessed the immunogenicity and safety of two candidate quadrivalent influenza vaccines (QIV) containing two A- and two B-strains (one from each lineage) in adults (18-60 years). Subjects were randomized and stratified by age to receive either QIV (non-adjuvanted or low-dose adjuvanted [LD QIV-AS]) or trivalent influenza vaccine (TIV, non-adjuvanted or low-dose adjuvanted [LD TIV-AS]), N = 105 in all treatment groups. The study evaluated the statistical non-inferiority of the immunological response elicited by QIV and LD QIV-AS versus TIV and LD TIV-AS and the statistical superiority of the response elicited by the quadrivalent vaccines against the B-strain (B/Jiangsu) not included in the TIV.

RESULTS

Pre-defined non-inferiority and superiority criteria were reached for both QIVs compared to the TIVs. On Day 21 in all vaccine groups SCRs were ≥54.8%, SPRs ≥88.5% and SCFs ≥5.4 for the A strains and B strain included in all vaccines (B/Malaysia). This fulfilled the European (CHMP) and the US (CBER) licensing criteria for the assessment of influenza vaccines in adults (CHMP criteria: SCR > 40%, SPR > 70%, SCF > 2; CBER criteria: LL of 95% CI for SPR ≥ 70% or SCR ≥ 40%). Only the QIVs met the CHMP and CBER criteria for the B/Jiangsu strain. In the QIV and LD-QIV-AS groups, the SCFs were 9.1 and 8.1, respectively and the SPRs were 98.1% and 95.2%, whereas for the TIV and LD-TIV-AS groups, the SCFs were 2.3 and 2.5, respectively, and the SPRs were 75.0% and 63.8%, with the LLs of the 95% CI <70% for SPR and <40% for SCR.

CONCLUSIONS

Addition of a fourth strain did not impact the immune response elicited by the three original strains contained in the TIV. A clear immunological benefit was seen with the QIV formulation for the second B-strain, indicating that quadrivalent vaccines could provide broader protection against influenza.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT00714285.

Authors+Show Affiliations

The Vaccination and Travel Medicine Center, Poliklinika II, Bratří Štefanu 895, Hradec Králové 500 03, Czech Republic. jiri.beran@vakcinace.czNo 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

23688546

Citation

Beran, Jiří, et al. "Immunogenicity and Safety of Quadrivalent Versus Trivalent Inactivated Influenza Vaccine: a Randomized, Controlled Trial in Adults." BMC Infectious Diseases, vol. 13, 2013, p. 224.
Beran J, Peeters M, Dewé W, et al. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013;13:224.
Beran, J., Peeters, M., Dewé, W., Raupachová, J., Hobzová, L., & Devaster, J. M. (2013). Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infectious Diseases, 13, 224. https://doi.org/10.1186/1471-2334-13-224
Beran J, et al. Immunogenicity and Safety of Quadrivalent Versus Trivalent Inactivated Influenza Vaccine: a Randomized, Controlled Trial in Adults. BMC Infect Dis. 2013 May 20;13:224. PubMed PMID: 23688546.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. AU - Beran,Jiří, AU - Peeters,Mathieu, AU - Dewé,Walthère, AU - Raupachová,Jolana, AU - Hobzová,Lenka, AU - Devaster,Jeanne-Marie, Y1 - 2013/05/20/ PY - 2012/06/17/received PY - 2013/05/10/accepted PY - 2013/5/22/entrez PY - 2013/5/22/pubmed PY - 2014/3/4/medline SP - 224 EP - 224 JF - BMC infectious diseases JO - BMC Infect. Dis. VL - 13 N2 - BACKGROUND: Two phylogenetic lineages of influenza B virus coexist and circulate in the human population (B/Yamagata and B/Victoria) but only one B-strain is included in each seasonal vaccine. Mismatch regularly occurs between the recommended and circulating B-strain. Inclusion of both lineages in vaccines may offer better protection against influenza. METHODS: This study (NCT00714285) assessed the immunogenicity and safety of two candidate quadrivalent influenza vaccines (QIV) containing two A- and two B-strains (one from each lineage) in adults (18-60 years). Subjects were randomized and stratified by age to receive either QIV (non-adjuvanted or low-dose adjuvanted [LD QIV-AS]) or trivalent influenza vaccine (TIV, non-adjuvanted or low-dose adjuvanted [LD TIV-AS]), N = 105 in all treatment groups. The study evaluated the statistical non-inferiority of the immunological response elicited by QIV and LD QIV-AS versus TIV and LD TIV-AS and the statistical superiority of the response elicited by the quadrivalent vaccines against the B-strain (B/Jiangsu) not included in the TIV. RESULTS: Pre-defined non-inferiority and superiority criteria were reached for both QIVs compared to the TIVs. On Day 21 in all vaccine groups SCRs were ≥54.8%, SPRs ≥88.5% and SCFs ≥5.4 for the A strains and B strain included in all vaccines (B/Malaysia). This fulfilled the European (CHMP) and the US (CBER) licensing criteria for the assessment of influenza vaccines in adults (CHMP criteria: SCR > 40%, SPR > 70%, SCF > 2; CBER criteria: LL of 95% CI for SPR ≥ 70% or SCR ≥ 40%). Only the QIVs met the CHMP and CBER criteria for the B/Jiangsu strain. In the QIV and LD-QIV-AS groups, the SCFs were 9.1 and 8.1, respectively and the SPRs were 98.1% and 95.2%, whereas for the TIV and LD-TIV-AS groups, the SCFs were 2.3 and 2.5, respectively, and the SPRs were 75.0% and 63.8%, with the LLs of the 95% CI <70% for SPR and <40% for SCR. CONCLUSIONS: Addition of a fourth strain did not impact the immune response elicited by the three original strains contained in the TIV. A clear immunological benefit was seen with the QIV formulation for the second B-strain, indicating that quadrivalent vaccines could provide broader protection against influenza. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00714285. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/23688546/Immunogenicity_and_safety_of_quadrivalent_versus_trivalent_inactivated_influenza_vaccine:_a_randomized_controlled_trial_in_adults_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-13-224 DB - PRIME DP - Unbound Medicine ER -