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Poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells is a vaccine component. It is one of three inactivated poliovirus strains — types 1, 2 and 3 — included in the six-in-one vaccine Infanrix hexa, which also protects against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and Haemophilus influenzae type b.[3] The product is authorised as a medicine in the European Union under authorisation record EU/1/00/152/001, held by GlaxoSmithKline Biologicals S.A.[3] The substance is classified in the registry under nervous system diseases, genetic phenomena, and immune system diseases.[3]
Inactivated poliovirus vaccines contain polioviruses that have been killed so they cannot cause disease. When injected, they prompt the immune system to make antibodies against the virus. These antibodies protect against polio, a disease that affects nerves and can lead to muscle weakness or paralysis.[6] The Mahoney strain is grown on Vero cells, a cell line used in vaccine production, and then inactivated.[3]
The vaccine is a suspension for injection given by intramuscular injection or intramuscular use.[3] It is available in vials and prefilled syringes, and a paediatric formulation exists for use in babies and toddlers from six weeks of age.[6] In the trials listed, it appears as a powder and suspension for suspension for injection, given intramuscularly.[3]
Five clinical trials list Infanrix hexa, the vaccine containing this poliovirus component, as an auxiliary product. This means the vaccine is given alongside the main study treatment, often to protect participants from infections during the trial or as part of the study design. The trials are not designed to test the poliovirus component itself.
The largest trial, NCT05082285, is a Phase 1 study in meningococcal infections with 703 participants.[3] The smallest, 2025-524635-39-00, is a Phase 1/2 study in X-linked hyper-IgM syndrome with 6 participants.[2] Conditions studied include meningococcal infections, whooping cough, myasthenia gravis, X-linked hyper-IgM syndrome, and complement-mediated kidney disease. Phases range from Phase 1 to Phase 3. Three trials are authorised or completed, and two are completed.[1]–[5]
Eligibility varies by trial. The meningococcal vaccine trial enrolled 703 participants, likely including infants and toddlers, since the vaccines studied are used in children.[3] The whooping cough trial enrolled 240 participants, focusing on pregnant women and their infants.[4] The myasthenia gravis trial enrolled 135 adults with AChR antibody-positive or antibody-negative generalized myasthenia gravis, or ocular myasthenia gravis.[1] The HIGM1 trial enrolled 6 patients with X-linked hyper-IgM syndrome type 1.[2] The kidney disease trial enrolled 45 participants with complement-mediated kidney disease.[5]
The trials measure safety and immune responses relevant to their main study drugs. The meningococcal trial measures solicited administration site and systemic events, unsolicited adverse events, and human serum bactericidal assay (hSBA) titres against meningococcal serogroups A, C, W, Y and B indicator strains.[3] The whooping cough trial measures the magnitude of antibody responses to pertussis vaccination.[4] The myasthenia gravis trial measures treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and changes in the MG-ADL total score and MGII ocular score.[1] The HIGM1 trial measures dose-limiting toxicities after each drug product dose.[2] The kidney disease trial measures the incidence and severity of TEAEs.[5]
The European Medicines Agency summary for Hexyon, a similar six-in-one vaccine containing the same inactivated poliovirus components, does not list specific side effects in the provided excerpt.[6] No side effect data specific to this poliovirus component is provided in the trial records or supplementary sources.
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