Tags

Type your tag names separated by a space and hit enter

Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults.
Vaccine. 2013 Jan 21; 31(5):770-6.V

Abstract

PURPOSE

To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two influenza B strains, one of each lineage, compared with licensed trivalent inactivated influenza vaccines (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a Yamagata B-lineage strain (2008-2009 TIV).

METHODS

Healthy adults ≥18 years of age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted in the US. Participants received a single dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 days after vaccine administration to test for hemagglutination inhibition (HAI) antibodies to each of the four influenza strains. Immunogenicity endpoints included geometric mean HAI antibody titers (GMTs) and rates of seroprotection (titer ≥1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety endpoints included frequency of solicited injection-site and systemic reactions occurring within 3 days of vaccination, and unsolicited non-serious adverse events (AEs) and serious AEs (SAEs) within 21 days of vaccination.

RESULTS

One hundred and ninety participants were enrolled to each vaccine group. QIV induced GMTs to each A and B strain that were noninferior to those induced by the 2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence interval of the ratio of GMT(QIV)/GMT(TIV)>0.66 for each strain). Rates of seroprotection and seroconversion were similar in all groups. Incidence and severity of solicited injection-site and systemic reactions, AEs, and SAEs were similar among groups.

CONCLUSION

QIV, containing two B strains (one from each B lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to be a useful alternative to TIV and offer protection against both B lineages.

Authors+Show Affiliations

Sanofi Pasteur, Swiftwater, PA 18370, USA. David.Greenberg@sanofipasteur.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

23228813

Citation

Greenberg, David P., et al. "Safety and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine Compared to Licensed Trivalent Inactivated Influenza Vaccines in Adults." Vaccine, vol. 31, no. 5, 2013, pp. 770-6.
Greenberg DP, Robertson CA, Noss MJ, et al. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. Vaccine. 2013;31(5):770-6.
Greenberg, D. P., Robertson, C. A., Noss, M. J., Blatter, M. M., Biedenbender, R., & Decker, M. D. (2013). Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. Vaccine, 31(5), 770-6. https://doi.org/10.1016/j.vaccine.2012.11.074
Greenberg DP, et al. Safety and Immunogenicity of a Quadrivalent Inactivated Influenza Vaccine Compared to Licensed Trivalent Inactivated Influenza Vaccines in Adults. Vaccine. 2013 Jan 21;31(5):770-6. PubMed PMID: 23228813.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a quadrivalent inactivated influenza vaccine compared to licensed trivalent inactivated influenza vaccines in adults. AU - Greenberg,David P, AU - Robertson,Corwin A, AU - Noss,Michael J, AU - Blatter,Mark M, AU - Biedenbender,Rex, AU - Decker,Michael D, Y1 - 2012/12/08/ PY - 2012/06/25/received PY - 2012/11/27/accepted PY - 2012/12/12/entrez PY - 2012/12/12/pubmed PY - 2013/7/3/medline SP - 770 EP - 6 JF - Vaccine JO - Vaccine VL - 31 IS - 5 N2 - PURPOSE: To evaluate the safety and immunogenicity of a prototype quadrivalent inactivated influenza vaccine (QIV) containing two influenza B strains, one of each lineage, compared with licensed trivalent inactivated influenza vaccines (TIVs) containing either a Victoria B-lineage strain (2009-2010 TIV) or a Yamagata B-lineage strain (2008-2009 TIV). METHODS: Healthy adults ≥18 years of age were eligible to participate in this phase II, open-label, randomized, controlled, multicenter study conducted in the US. Participants received a single dose of 2009-2010 TIV, 2008-2009 TIV, or QIV. Sera were collected before and 21 days after vaccine administration to test for hemagglutination inhibition (HAI) antibodies to each of the four influenza strains. Immunogenicity endpoints included geometric mean HAI antibody titers (GMTs) and rates of seroprotection (titer ≥1:40) and seroconversion (4-fold rise pre- to post-vaccination). Safety endpoints included frequency of solicited injection-site and systemic reactions occurring within 3 days of vaccination, and unsolicited non-serious adverse events (AEs) and serious AEs (SAEs) within 21 days of vaccination. RESULTS: One hundred and ninety participants were enrolled to each vaccine group. QIV induced GMTs to each A and B strain that were noninferior to those induced by the 2009-2010 and 2008-2009 TIVs (i.e., lower limit of the two-sided 95% confidence interval of the ratio of GMT(QIV)/GMT(TIV)>0.66 for each strain). Rates of seroprotection and seroconversion were similar in all groups. Incidence and severity of solicited injection-site and systemic reactions, AEs, and SAEs were similar among groups. CONCLUSION: QIV, containing two B strains (one from each B lineage), was as safe and immunogenic as licensed TIV. QIV has the potential to be a useful alternative to TIV and offer protection against both B lineages. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/23228813/Safety_and_immunogenicity_of_a_quadrivalent_inactivated_influenza_vaccine_compared_to_licensed_trivalent_inactivated_influenza_vaccines_in_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)01724-0 DB - PRIME DP - Unbound Medicine ER -