A Phase I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU

The main purpose of the this study is to evaluate the safety and tolerability of Immunose™ FLU based on Endocine™ and quadrivalent influenza antigen.

Start Date01 Sep 2016

Sponsor / Collaborator

Eurocine Vaccines AB

100 Clinical Results associated with Quadrivalent influenza virus vaccine (Eurocine Vaccines)

100 Translational Medicine associated with Quadrivalent influenza virus vaccine (Eurocine Vaccines)

100 Patents (Medical) associated with Quadrivalent influenza virus vaccine (Eurocine Vaccines)

Literatures (Medical) associated with Quadrivalent influenza virus vaccine (Eurocine Vaccines)

01 May 2024·The Lancet Infectious Diseases

Quadrivalent dengue-virus vaccines: challenges and opportunities for India

Letter

Author: Medigeshi, Guruprasad R ; Islam, Farzana ; Lodha, Rakesh

01 Jan 2024·Journal of Medical Virology

Cost‐effectiveness analysis of cell‐based versus egg‐based quadrivalent influenza vaccines in the pediatric population in Taiwan

Article

Author: Mould, Joaquin F ; Cheng, Ming-Fang ; Ko, Karam ; Chen, Chih-Jung ; Chi, Chia-Yu ; Huang, Yhu-Chering ; Lee, Ping-Ing

AbstractCell‐based influenza vaccines avoid egg‐adaptive mutations, potentially improving vaccine effectiveness. We assessed the one‐season cost‐effectiveness of cell‐based quadrivalent influenza vaccine (QIVc) against that of egg‐derived quadrivalent influenza vaccines (QIVe) in children (6 months to 17 years of age) from payer and societal perspectives in Taiwan using an age‐stratified static model. Base case and high egg adaptation scenarios were assessed. Deterministic and probabilistic sensitivity analyses were performed. The incremental cost‐effectiveness ratio (ICER) threshold in Taiwan was assumed to be USD 99 177/quality‐adjusted life year (QALY). Compared to QIVe, QIVc would prevent 15 665 influenza cases, 2244 complicated cases, and 259 hospitalizations per year. The base case ICER was USD 68 298/QALY and USD 40 085/QALY from the payer and societal perspective, respectively. In the high egg adaptation scenario, the ICER was USD 45 782/QALY from the payer's perspective and USD 17 489/QALY from the societal perspective. Deterministic sensitivity analyses indicated that infection incidence rate, vaccination coverage, and prevalence of the A/H3N2 strain were the main drivers of ICER. In conclusion, switching the immunization strategy from QIVe to QIVc is predicted to reduce the influenza‐associated disease burden and be cost‐effective for the pediatric population in Taiwan. The potential benefits of QIVc would be even higher during influenza seasons with high levels of egg adaptation.

31 Dec 2023·Expert Review of Vaccines

Immunogenicity and safety of seasonal influenza vaccines in children under 3 years of age

Review

Author: Arkwright, Peter D. ; Borrow, Ray ; Aoun, Tia

INTRODUCTIONDespite children aged 6-35 months developing more severe influenza infections, not all countries include influenza vaccines in their national immunization programs.AREAS COVEREDThis literature review examines the efficacy, immunogenicity, and safety of seasonal trivalent influenza vaccines (TIVs) and quadrivalent influenzae vaccines (QIVs) in children 6-35 months old to determine if greater valency promotes greater protection while maintaining a similar safety profile.EXPERT OPINIONTIVs and QIVs are safe for children under 3 years old. TIVs and QIVs provided good seroprotection, and immunogenicity (GMT, SCR, and SPR) meeting recommended levels set by CHMP (European) and CBER (USA). However, as QIVs carry two influenza B strains and TIVs only one, QIVs has an overall higher seroprotection against particularly influenza B. Vaccines containing adjuncts had better immunogenicity, particularly after the first dose. Seroprotection of all vaccines lasted 12 months. Increasing the dosage from 0.25 mL to 0.5 mL did not cause more systemic or local side-effects. Further comparisons of efficacy, and wider promotion of influenza vaccines in general are required in preschool children.

100 Deals associated with Quadrivalent influenza virus vaccine (Eurocine Vaccines)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 2	SE	Eurocine Vaccines AB	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02998996 (CTgov)	Phase 1/2	Influenza, Human	162	15 µg HA/strain and 1% Endocine™ (Immunose™ FLU 1%,)	ztfaetqxpj(yqgkrivmbo) = mntnjcllvo cxnarhavqv (gxnnolelnr, pszscduidw - niquimglyz) View more	-	21 Feb 2019
				15 µg HA/strain and 2% Endocine™ (Immunose™ FLU 2%,)	ztfaetqxpj(yqgkrivmbo) = wvwmaipmbx cxnarhavqv (gxnnolelnr, lqqoxxcire - empyxpedbh) View more

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