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Influenza inactivated split virus strain B is an inactivated (killed) influenza B virus component used in vaccines. It is part of a fixed combination product in one registry record, alongside influenza A strain components.[1] The substance is produced by GlaxoSmithKline Biologicals S.A. and is classified in the therapeutic area of virus diseases.[1] In the product records of the registered trials, it has no marketing authorisation and is described as an investigational substance.[1] However, influenza vaccines made from split virions, inactivated, are authorised nationally in several European countries under trade names such as Fluarix, Vaxigrip, Alpharix, and Influsplit.[4]
Influenza vaccines made from split virions, inactivated, work by exposing the immune system to pieces of the influenza virus that cannot cause infection. This exposure triggers the body to produce antibodies against the virus. The authorised indication for this type of vaccine is prophylaxis against influenza in adults and children.[5] The clinical trials measure the immune response by looking at antibody titers, seroconversion (the development of detectable antibodies), and seroprotection (antibody levels considered protective).[1][3]
The substance is a suspension for injection given by intramuscular use.[1] In the trials, the vaccine is administered as a 0.5 ml injection into the muscle.[1][3] Authorised influenza vaccines made from split virions, inactivated, are also available as injections in pre-filled syringes.[4]
Three registered clinical trials study influenza inactivated split virus strain B as part of influenza vaccines. Two Phase 2 trials are completed and enrolled 770 and 960 adults aged 18 years and older.[1][3] One Phase 3 trial is authorised and enrolled 8,015 adults aged 60 years and older.[2]
The Phase 2 trials measured antibody titers at day 29, the fold increase in antibody titers from day 1 to day 29, seroconversion, and seroprotection.[1][3] They also assessed solicited administration site or systemic events within 7 days, unsolicited adverse events within 28 days, and serious adverse events, adverse events of special interest, and medically attended adverse events within 6 months.[1][3]
The Phase 3 trial aims to demonstrate non-inferiority in influenza-specific immune responses between a combination vaccine and a comparator arm for each of the three influenza vaccine strains, and non-inferiority in SARS-CoV-2 variant-specific immune responses.[2] It measures antibody titers against the three influenza vaccine strains and against a SARS-CoV-2 specific variant in a subset of participants.[2]
According to a European Union periodic safety update report, the benefit-risk profile of influenza vaccines made from split virions, inactivated, remains favourable, and no new major findings affecting the overall safety profile were identified.[5] The clinical trials measure solicited administration site or systemic events, unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended adverse events.[1][3]
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