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Tetanus protein is a bacterial protein derived from the tetanus toxoid. In the registered trial, it appears as part of the fixed combination vaccine Hexyon, which contains diphtheria toxoid, tetanus toxoid, pertussis components (filamentous haemagglutinin and pertussis toxoid adsorbed on aluminium hydroxide), hepatitis B surface antigen, inactivated poliovirus types 1, 2, and 3, and Haemophilus influenzae type b conjugate vaccine, where tetanus protein serves as the conjugate carrier.[1] Hexyon is authorised as a medicine in the European Union, with marketing authorisation record EU/1/13/829/002 held by Sanofi Pasteur Europe.[1] The substance is given as a suspension for injection by intramuscular injection.[1]
Tetanus is caused by spores of the bacterium Clostridium tetani that enter the body through cuts or wounds.[4] The bacteria produce a toxin that causes painful muscle stiffness and spasms, often starting in the jaw — a symptom called lockjaw.[2] Tetanus protein, as part of tetanus-toxoid-containing vaccines (TTCV), works by teaching the immune system to recognise and neutralise the tetanus toxin before it can cause harm. Vaccination with TTCV is the main way to prevent tetanus.[4] People who recover from tetanus do not develop natural immunity and remain at risk, so vaccination is still recommended.[4]
The combination vaccine containing tetanus protein is given as a suspension for injection by intramuscular injection.[1] In the registered trial, Hexyon is administered at a dose of 0.5 millilitres.[1] The World Health Organization reports that vaccination schedules typically include three doses of a diphtheria-tetanus-pertussis (DTP) containing vaccine in infancy, with 85% of infants worldwide vaccinated with three doses in 2025.[4]
One registered trial involves tetanus protein, where the combination vaccine Hexyon serves as an auxiliary vaccine rather than the main study drug. The trial is a Phase 2 interventional study authorised in the EU CTIS with identifier 2023-510465-10-00, enrolling 750 healthy children, toddlers, and infants.[1]
The trial investigates the safety and immunogenicity of an investigational pentavalent meningococcal ABCYW vaccine (MenPenta). Participants receive Hexyon alongside other vaccines, including Nimenrix (meningococcal ACWY conjugate vaccine), Prevenar 13 (pneumococcal conjugate vaccine), MenQuadfi (meningococcal ACWY conjugate vaccine), RotaTeq (rotavirus vaccine), and Bexsero (meningococcal group B vaccine).[1]
The primary outcomes measure immune responses to meningococcal serogroups A, C, W, Y, and B using hSBA (serum bactericidal antibody) titres, including seroresponse rates and geometric mean titres before and after vaccination. Safety outcomes include solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events.[1]
The trial enrols healthy children (Stage 1), toddlers (Stage 2), and infants (Stage 3). Infants receive vaccinations at approximately 4 months of age and again at 12–15 months of age.[1]
The trial records solicited injection site reactions and systemic reactions as primary safety outcomes, along with unsolicited adverse events and serious adverse events.[1] The periodic safety update report for human tetanus immunoglobulin, a related tetanus product, concluded a regulatory outcome of maintenance, meaning no new safety concerns were identified.[3] Tetanus itself can cause serious complications, including laryngospasm, fractures, pulmonary embolism, aspiration pneumonia, and breathing difficulty; about 1 in 10 cases in the United States are fatal.[2]
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