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Pertussis toxoid adsorbed on aluminium hydroxide, hydrated is a detoxified form of the pertussis toxin produced by the bacterium Bordetella pertussis, the cause of whooping cough. The toxin is chemically inactivated so it can no longer cause disease, while still triggering a protective immune response. The substance is part of acellular pertussis vaccines, which contain purified components of the bacterium rather than whole killed cells.[8]
In the EU Clinical Trials Information System (CTIS), this substance appears within authorised combination vaccines.
In the six clinical trial records provided, the substance plays different roles: it is an auxiliary medicine in 3 trials, the test substance in 1 trial, and part of a placebo arm in 1 trial. In four product records the substance is part of a fixed combination vaccine, and a paediatric formulation exists in two product records.[1][2]
Pertussis toxoid works by teaching the immune system to recognise and neutralise the pertussis toxin before it can cause harm. The native pertussis toxin is a key virulence factor of Bordetella pertussis, responsible for many of the systemic effects of whooping cough. When the toxin is inactivated into a toxoid and adsorbed onto aluminium hydroxide, it becomes a safe vaccine antigen. The aluminium hydroxide acts as an adjuvant, enhancing the immune response to the toxoid.[8]
After injection, immune cells encounter the toxoid and produce antibodies specifically directed against the pertussis toxin. These antibodies can bind to and neutralise the toxin during a later infection, preventing the severe coughing fits and other complications of whooping cough. The Paul-Ehrlich-Institut, Germany's federal institute for vaccines and biomedical medicines, confirms that pertussis vaccines provide protection against infections with Bordetella pertussis.[7]
The substance is formulated as a suspension for injection and is given by intramuscular injection. In the CTIS product records, the route of administration is listed as intramuscular injection, intramuscular use or intramuscular. The combination vaccines containing the pertussis toxoid — Infanrix hexa, Hexyon and Tetravac — are all administered as 0.5 ml intramuscular injections.[1][2] The substance is part of fixed combination products in four product records, meaning it is given together with other vaccine antigens in a single injection. A paediatric formulation is available in two product records, reflecting the use of these vaccines in infants and children.[1]
Six clinical trial records mention pertussis toxoid adsorbed on aluminium hydroxide, hydrated. In five of these, the substance is not the main focus of the research but appears as an auxiliary medicine — a routine childhood vaccine given alongside the investigational product. Only one trial, the completed Phase 3 study 2024-510787-23-00 (MIFI-4Y), directly investigates a vaccine containing this substance.[2]
The MIFI-4Y trial enrolled 138 participants and examined maternal pertussis immunisation in Finland. Its primary outcome was the PT-specific IgG antibody geometric mean concentration (GMC) at 4 years plus 28 days in children whose mothers were vaccinated during pregnancy compared with control children. The study aimed to investigate possible long-lasting differences in pertussis immunity at 48 months of age.[2] The trial is now completed.
The largest trial in which the substance appears is 2023-510465-10-00, a Phase 2 study of an investigational pentavalent meningococcal ABCYW vaccine. This authorised trial enrolled 750 participants and includes Infanrix hexa as an auxiliary medicine. Its primary outcomes measure safety — solicited injection site reactions, systemic reactions, unsolicited adverse events and serious adverse events — as well as immune responses measured by human serum bactericidal assay (hSBA) against meningococcal serogroups A, C, W, Y and B.[1]
Other trials include NCT05082285, a completed Phase 1 study with 703 participants evaluating MenABCWY vaccine formulations, where Infanrix hexa serves as an auxiliary medicine; 2025-522406-20-00, an authorised Phase 1 study of IM-101 in myasthenia gravis with 135 participants; 2025-524635-39-00, an authorised Phase 1/2 study of gene-edited T-cells in HIGM1 with 6 participants; and NCT06989359, an authorised Phase 2 study of ADX-038 in complement-mediated kidney disease with 45 participants.[3]–[6]
The trials cover a broad range of conditions. Two trials focus on meningococcal immunisation, one on pertussis, one on myasthenia gravis, one on a rare immunodeficiency, and one on complement-mediated kidney disease. The phases range from Phase 1 to Phase 3. Trial statuses include Authorised (three trials), Completed (two trials), and one trial listed as Authorised in the EU system with an NCT identifier.[1]–[6]
What is measured in these trials varies widely. The meningococcal vaccine trials measure immune responses using hSBA titres — a laboratory test that measures how well antibodies in the blood can kill meningococcal bacteria — as well as safety outcomes such as solicited injection site reactions and adverse events. The MIFI-4Y trial measures PT-specific IgG antibody concentrations, which reflect the level of antibodies against pertussis toxin in children's blood. The myasthenia gravis trial measures safety outcomes and changes in the MG-ADL total score, a measure of daily living impact, while the HIGM1 trial measures dose-limiting toxicities.[1]–[4]
Participants in these trials include healthy infants, toddlers and children in the meningococcal vaccine studies; children aged approximately 48 months in the MIFI-4Y trial; adults with myasthenia gravis; patients with HIGM1; and adults with complement-mediated kidney disease. The trials are conducted in multiple countries, with the MIFI-4Y trial specifically conducted in Finland.[1][2][6]
The Paul-Ehrlich-Institut lists pertussis vaccines as authorised medicinal products in Germany, with information available through the national medicines database PharmNet.Bund. The vaccines containing pertussis toxoid are combination vaccines that also protect against diphtheria and tetanus, and their safety is monitored through routine pharmacovigilance.[7]
In the clinical trials listed, the safety of the combination vaccines containing pertussis toxoid is assessed through the collection of solicited injection site reactions, systemic reactions, unsolicited adverse events and serious adverse events. These are standard safety measures used in vaccine clinical trials to identify any unwanted effects after vaccination.[1]
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