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Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial.
Vaccine. 2014 Mar 14; 32(13):1480-7.V

Abstract

BACKGROUND

Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.

METHODS

Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.

RESULTS

Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.

CONCLUSION

QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.

Authors+Show Affiliations

Hospital General de Durango, Durango, Mexico. Electronic address: jctinoco@prodigy.net.mx.Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.National Institute of Public Health, Cuernavaca, Morelos, Mexico.Secretaria de Salud del Estado de Mexico, Zumpango, Mexico.GlaxoSmithKline Vaccines, King of Prussia, PA, USA.GlaxoSmithKline Vaccines, Rixensart, Belgium.GlaxoSmithKline Vaccines, King of Prussia, PA, USA.GlaxoSmithKline Vaccines, King of Prussia, PA, USA.GlaxoSmithKline Vaccines, King of Prussia, PA, USA.

Pub Type(s)

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

Language

eng

PubMed ID

24486352

Citation

Tinoco, Juan Carlos, et al. "Immunogenicity, Reactogenicity, and Safety of Inactivated Quadrivalent Influenza Vaccine Candidate Versus Inactivated Trivalent Influenza Vaccine in Healthy Adults Aged ≥18 Years: a Phase III, Randomized Trial." Vaccine, vol. 32, no. 13, 2014, pp. 1480-7.
Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, et al. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial. Vaccine. 2014;32(13):1480-7.
Tinoco, J. C., Pavia-Ruz, N., Cruz-Valdez, A., Aranza Doniz, C., Chandrasekaran, V., Dewé, W., Liu, A., Innis, B. L., & Jain, V. K. (2014). Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial. Vaccine, 32(13), 1480-7. https://doi.org/10.1016/j.vaccine.2014.01.022
Tinoco JC, et al. Immunogenicity, Reactogenicity, and Safety of Inactivated Quadrivalent Influenza Vaccine Candidate Versus Inactivated Trivalent Influenza Vaccine in Healthy Adults Aged ≥18 Years: a Phase III, Randomized Trial. Vaccine. 2014 Mar 14;32(13):1480-7. PubMed PMID: 24486352.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial. AU - Tinoco,Juan Carlos, AU - Pavia-Ruz,Noris, AU - Cruz-Valdez,Aurelio, AU - Aranza Doniz,Carlos, AU - Chandrasekaran,Vijayalakshmi, AU - Dewé,Walthère, AU - Liu,Aixue, AU - Innis,Bruce L, AU - Jain,Varsha K, Y1 - 2014/01/28/ PY - 2013/06/11/received PY - 2013/12/12/revised PY - 2014/01/14/accepted PY - 2014/2/4/entrez PY - 2014/2/4/pubmed PY - 2014/8/21/medline KW - Inactivated quadrivalent influenza vaccine KW - Seasonal influenza KW - Victoria lineage KW - Yamagata lineage SP - 1480 EP - 7 JF - Vaccine JO - Vaccine VL - 32 IS - 13 N2 - BACKGROUND: Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. METHODS: Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. RESULTS: Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. CONCLUSION: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/24486352/Immunogenicity_reactogenicity_and_safety_of_inactivated_quadrivalent_influenza_vaccine_candidate_versus_inactivated_trivalent_influenza_vaccine_in_healthy_adults_aged_≥18_years:_a_phase_III_randomized_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(14)00054-1 DB - PRIME DP - Unbound Medicine ER -