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Influenza quadrivalent vaccine (rDNA) is a vaccine designed to protect against four strains of the influenza virus. In the product records of the clinical trial, the substance appears under the name TETRALITE, and the company supplying it is LITEVAX BV.[1] The registry classifies it as a structurally diverse substance of vaccine origin, and the therapeutic area is virus diseases.[1] The product records contain no marketing authorisation, which means TETRALITE is still an investigational substance at this stage.[1]
The name \"quadrivalent\" means the vaccine targets four influenza virus strains. According to a European public risk-management summary, historically influenza vaccines were trivalent, containing two influenza A subtypes and one influenza B lineage. Because two lineages of influenza B viruses have co-circulated since 2001, quadrivalent vaccines were developed to cover both B lineages in addition to the two A subtypes.[4] The European Medicines Agency has assessed a related recombinant quadrivalent influenza vaccine under the trade name Supemtek Tetra, prepared in cell culture.[3]
Influenza vaccines work by exposing the immune system to inactivated or recombinant influenza virus components, so the body can build a defence before it meets the real virus. The public risk-management summary explains that after vaccination, protection against flu generally lasts 6 to 12 months, and because influenza viruses change from year to year, the vaccine composition is updated every year based on recommendations from the World Health Organization.[4] TETRALITE is described in the trial record as a \"novel adjuvanted influenza vaccine\". An adjuvant is a substance added to a vaccine to strengthen the immune response. In the Phase 1 trial, TETRALITE combined a low dose of Vaxigrip Tetra antigen (3 µg) with either 1 mg or 4 mg of a novel adjuvant, compared with the standard 15 µg Vaxigrip Tetra without adjuvant.[1]
TETRALITE is a suspension for injection given by the intramuscular route, meaning it is injected into a muscle.[1] In the Phase 1 trial, a single 0.5 ml dose was administered intramuscularly.[1] The active comparator in the trial, Vaxigrip Tetra, is a quadrivalent influenza vaccine (split virion, inactivated) supplied as a suspension for injection in a pre-filled syringe, also given as a 0.5 ml intramuscular injection.[1]
One clinical trial of TETRALITE is registered in the EU Clinical Trials Information System. It is a Phase 1, first-in-human, randomised, observer-blind, active-controlled study with three arms, conducted at a single centre.[1] The trial is completed. It enrolled 60 healthy participants aged 18 to 50 years.[1]
The study compared one single administration of TETRALITE at two adjuvant doses — 3 µg Vaxigrip Tetra antigen plus 1 mg or 4 mg adjuvant — against the licensed vaccine Vaxigrip Tetra at the standard 15 µg dose without adjuvant.[1] The primary objective was to evaluate safety and tolerability. The trial measured solicited local and systemic adverse events for 7 days after vaccination, unsolicited adverse events for 28 days, and serious adverse events, potential immune-mediated disorders, and adverse events of special interest for 180 days. It also recorded clinically abnormal haematology and serum biochemistry laboratory values at 7, 28, and 180 days after vaccination compared with baseline.[1]
Because the trial is a first-in-human Phase 1 study, its main purpose is to establish whether the vaccine is safe and tolerable, not yet to prove how well it protects against flu. No efficacy results are reported in the registry record.[1]
No side-effect results from the TETRALITE trial are reported in the registry record. However, side effects of inactivated influenza vaccines in general are documented. A medicines information source lists common side effects of inactivated influenza vaccines as headache, joint or muscle pain, and pain at the injection site. Less common side effects include diarrhoea, loss of appetite, nausea or vomiting, and redness or swelling at the injection site.[2] A serious allergic reaction called anaphylaxis can occur after influenza vaccination and requires immediate medical attention; signs include rash, itching, swelling of the tongue and throat, or troubled breathing.[2]
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