The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Using imported GSK's TIV as control, to compare it with other two domestic TIVs in Chinese healthy servicemen.

Start Date01 Oct 2014

Sponsor / Collaborator-

100 Clinical Results associated with Trivalent Seasonal Influenza Vaccine(Instituto Butantan)

100 Translational Medicine associated with Trivalent Seasonal Influenza Vaccine(Instituto Butantan)

100 Patents (Medical) associated with Trivalent Seasonal Influenza Vaccine(Instituto Butantan)

Literatures (Medical) associated with Trivalent Seasonal Influenza Vaccine(Instituto Butantan)

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.

22 May 2023·Vaccine

A randomized, double-blind, non-inferiority trial comparing the immunogenicity and safety of two seasonal inactivated influenza vaccines in adults.

Article

Author: Koike, Marcelo Eiji ; da Silva, Anderson ; de Oliveira, Mayra Martho Moura ; Paiva, Terezinha M. ; do Prado Santos, Joane ; de Oliveira Piorelli, Roberta ; Lara, Amanda Nazareth ; Coelho, Eduardo B. ; Braga, Patricia Emilia ; Precioso, Alexander Roberto ; da Graca Salomao, Maria ; Weckx, Lily Yin ; Vanni, Tazio ; Gattas, Vera Lucia ; Viscondi, Juliana Yukari Kodaira ; Lucchesi, Maria Beatriz Bastos ; Timenetsky, Maria do Carmo S. T. ; Campos, Lucia M. A.

BACKGROUNDTo enhance the production and availability of influenza vaccines in different regions of the world is paramount to mitigate the global burden of this disease. Instituto Butantan developed and manufactured an embryonated egg-based inactivated split-virion trivalent seasonal influenza vaccine as part of a technology transfer partnership with Sanofi Pasteur.METHODSThis is a phase IV, randomized, double-blind, active-controlled, multicenter clinical trial including adults 18-60 and > 60 years recruited during the 2019 southern hemisphere influenza season. Subjects were randomized 1:1 to receive either the Sanofi Pasteur Trivalent Seasonal Influenza Vaccine (SP-TIV) or Instituto Butantan Trivalent Seasonal Influenza Vaccine (IB-TIV). Hemagglutinin inhibition antibody titers were assessed pre-vaccination and 21 days post-vaccination.RESULTS624 participants were randomized and vaccinated. In both intention-to-treat and per-protocol analysis, non-inferiority of the SP-TIV versus IB-TIV was demonstrated for the three influenza strains. In the per-protocol analysis, the SP-GMT/IB-GMT ratios for H1N1, H3N2, and B were 0.9 (95%CI, 0.7-1.1), 1.2 (95%CI, 1.0-1.4), and 1.1 (95%CI, 0.9-1.3), respectively. Across vaccination groups, the most common adverse reactions (AR) were limited to the injection-site, including pain and tenderness. The majority of the ARs were graded 1 and/or 2 and lasted less than one day. No serious adverse reaction was observed.CONCLUSIONThis study demonstrated the non-inferiority of the immunogenicity of a single-dose of Instituto Butantan versus a single dose of the Sanofi Pasteur Seasonal Trivalent Influenza Vaccine in adults. Both vaccines were well tolerated and presented similar safety profiles.

01 Oct 2022·Respirology

Effectiveness of influenza and pneumococcal vaccines on chronic obstructive pulmonary disease exacerbations

Article

Author: Wang, Huaqing ; Wang, Liye ; Yin, Zundong ; An, Zhijie ; Zhang, Pingshu ; Li, Yan ; Wang, Yamin ; Yue, Chenyan ; Li, Keli ; Yuan, Xiaodong ; Liu, Yunqiu ; Ma, Ying

AbstractBackground and objectiveSingle‐study evidence of separate and combined effectiveness of influenza and pneumococcal vaccination in patients with chronic obstructive pulmonary disease (COPD) is limited. To fill this gap, we studied the effectiveness of trivalent seasonal influenza vaccine (TIV) and 23‐valent pneumococcal polysaccharide vaccine (PPSV23), separately and together, at preventing adverse COPD outcomes.MethodsOur study used a self‐controlled, before‐and‐after cohort design to assess the effectiveness of TIV and PPSV23 in COPD patients. Patients were recruited from hospitals in Tangshan City, Hebei Province, China. Subjects self‐selected into one of the three vaccination schedules: TIV group, PPSV23 group and TIV&PPSV23 group. We used a physician‐completed, medical record‐verified questionnaire to obtain data on acute exacerbations of COPD (AECOPD), pneumonia and related hospitalization. Vaccine effectiveness was determined by comparing COPD outcomes before and after vaccination, controlling for potential confounding using Cox regression.ResultsWe recruited 474 COPD patients, of whom 109 received TIV, 69 received PPSV23 and 296 received TIV and PPSV23. Overall effectiveness for preventing AECOPD, pneumonia and related hospitalization were respectively 70%, 59% and 58% in the TIV group; 54%, 53% and 46% in the PPSV23 group; and 72%, 73% and 69% in the TIV&PPSV23 group. The vaccine effectiveness without COVID‐19 non‐pharmaceutical intervention period were 84%, 77% and 88% in the TIV group; 63%, 74% and 66% in the PPSV23 group; and 82%, 83% and 91% in the TIV&PPSV23 group.ConclusionInfluenza vaccination and PPSV23 vaccination, separately and together, can effectively reduce the risk of AECOPD, pneumonia and related hospitalization. Effectiveness for preventing AECOPD was the greatest.

100 Deals associated with Trivalent Seasonal Influenza Vaccine(Instituto Butantan)

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Indication	Country/Location	Organization	Date
Influenza, Human	BR	Instituto Butantan	01 Jan 2013

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