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A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine--Assessing the immunogenicity and safety in an open label, uncontrolled study.
Hum Vaccin Immunother 2015; 11(10):2370-5HV

Abstract

The present study evaluated the safety and immunogenicity of the 2013/2014 trivalent surface antigen inactivated subunit seasonal influenza virus vaccine Fluvirin® in healthy adults (18 - ≤ 60 years) and elderly (>60 years). The vaccine contained 15 µg haemagglutinin protein from each of influenza A/California/7/2009 (H1N1)pdm09-like strain, A/Victoria/361/2011 (H3N2)-like strain and B/Massachusetts/2/2012-like strain (B/Yamagata) as recommended by the WHO in the 2013/2014 Northern Hemisphere season. Antibody response to each influenza antigen after vaccination was measured prior to vaccination and 21 d after by single radial hemolysis (SRH) assay or hemagglutination inhibition (HI) assay in accordance with Guidance CPMP/BWP/214/96. 125 subjects (61 adults and 64 elderly) were enrolled in the study. Pre-vaccination protective antibody levels (SRH area ≥ 25 mm(2)) against A(H1N1), A(H3N2) and the B strain were detected in 17%, 20% and 57% of adults and in 36%, 20% and 55% of elderly, respectively, Post-vaccination, SRH area ≥ 25 mm(2) was detectable in 95%, 82% and 92% in adult and in 80%, 84% and 92% of the elderly subjects for A(H1N1), A(H3N2) and the B strain, respectively. Geometric mean ratio (GMR) was higher in adult subjects (2.62-7.62) than in elderly subjects (2.33-3.42). All three CHMP licensure criteria were met for all strains contained in the vaccine for both age groups. The most frequently reported solicited local and systemic reactions were pain at the injection side, headache and fatigue. In conclusion, the vaccine demonstrated a good immunogenicity and an acceptable safety profile in both adults and elderly.

Authors+Show Affiliations

a Section Tropical Medicine; I. Department for Internal Medicine ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany. b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.a Section Tropical Medicine; I. Department for Internal Medicine ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany. b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.c Novartis Vaccines and Diagnostics ; Marburg , Germany.c Novartis Vaccines and Diagnostics ; Marburg , Germany.b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany. d Department of Pediatric Hematology and Oncology ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany.b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.a Section Tropical Medicine; I. Department for Internal Medicine ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany. b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.a Section Tropical Medicine; I. Department for Internal Medicine ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany. b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.a Section Tropical Medicine; I. Department for Internal Medicine ; University Medical Center Hamburg-Eppendorf ; Hamburg , Germany. b Bernhard Nocht Center for Clinical Trials (BNCCT) ; Hamburg , Germany.

Pub Type(s)

Clinical Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26114800

Citation

Roggelin, Louise, et al. "A 2013/2014 Northern Hemisphere Season Surface Antigen Inactivated Trivalent Influenza vaccine--Assessing the Immunogenicity and Safety in an Open Label, Uncontrolled Study." Human Vaccines & Immunotherapeutics, vol. 11, no. 10, 2015, pp. 2370-5.
Roggelin L, Vinnemeier CD, Meyer S, et al. A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine--Assessing the immunogenicity and safety in an open label, uncontrolled study. Hum Vaccin Immunother. 2015;11(10):2370-5.
Roggelin, L., Vinnemeier, C. D., Meyer, S., Witte, K., Marx, L., Theeβ, W., ... Cramer, J. P. (2015). A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine--Assessing the immunogenicity and safety in an open label, uncontrolled study. Human Vaccines & Immunotherapeutics, 11(10), pp. 2370-5. doi:10.1080/21645515.2015.1064570.
Roggelin L, et al. A 2013/2014 Northern Hemisphere Season Surface Antigen Inactivated Trivalent Influenza vaccine--Assessing the Immunogenicity and Safety in an Open Label, Uncontrolled Study. Hum Vaccin Immunother. 2015;11(10):2370-5. PubMed PMID: 26114800.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine--Assessing the immunogenicity and safety in an open label, uncontrolled study. AU - Roggelin,Louise, AU - Vinnemeier,Christof D, AU - Meyer,Seetha, AU - Witte,Kai, AU - Marx,Lydia, AU - Theeβ,Wiebke, AU - Burchard,Gerd D, AU - Rolling,Thierry, AU - Cramer,Jakob P, PY - 2015/6/27/entrez PY - 2015/6/27/pubmed PY - 2016/6/21/medline KW - H1N1 KW - H3N2 KW - fluvirin KW - influenza KW - trivalent KW - vaccine SP - 2370 EP - 5 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 11 IS - 10 N2 - The present study evaluated the safety and immunogenicity of the 2013/2014 trivalent surface antigen inactivated subunit seasonal influenza virus vaccine Fluvirin® in healthy adults (18 - ≤ 60 years) and elderly (>60 years). The vaccine contained 15 µg haemagglutinin protein from each of influenza A/California/7/2009 (H1N1)pdm09-like strain, A/Victoria/361/2011 (H3N2)-like strain and B/Massachusetts/2/2012-like strain (B/Yamagata) as recommended by the WHO in the 2013/2014 Northern Hemisphere season. Antibody response to each influenza antigen after vaccination was measured prior to vaccination and 21 d after by single radial hemolysis (SRH) assay or hemagglutination inhibition (HI) assay in accordance with Guidance CPMP/BWP/214/96. 125 subjects (61 adults and 64 elderly) were enrolled in the study. Pre-vaccination protective antibody levels (SRH area ≥ 25 mm(2)) against A(H1N1), A(H3N2) and the B strain were detected in 17%, 20% and 57% of adults and in 36%, 20% and 55% of elderly, respectively, Post-vaccination, SRH area ≥ 25 mm(2) was detectable in 95%, 82% and 92% in adult and in 80%, 84% and 92% of the elderly subjects for A(H1N1), A(H3N2) and the B strain, respectively. Geometric mean ratio (GMR) was higher in adult subjects (2.62-7.62) than in elderly subjects (2.33-3.42). All three CHMP licensure criteria were met for all strains contained in the vaccine for both age groups. The most frequently reported solicited local and systemic reactions were pain at the injection side, headache and fatigue. In conclusion, the vaccine demonstrated a good immunogenicity and an acceptable safety profile in both adults and elderly. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/26114800/A_2013/2014_northern_hemisphere_season_surface_antigen_inactivated_trivalent_influenza_vaccine__Assessing_the_immunogenicity_and_safety_in_an_open_label_uncontrolled_study_ L2 - http://www.tandfonline.com/doi/full/10.1080/21645515.2015.1064570 DB - PRIME DP - Unbound Medicine ER -