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Tetanus toxoid adsorbed on aluminium hydroxide, hydrated is an inactivated form of the tetanus toxin used as a vaccine component. It is not given as a standalone product in the trials reviewed here; instead, it appears as part of authorised combination vaccines. The product names listed in the registry include Infanrix hexa, a powder and suspension for injection covering diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b, and Tetravac, a Finnish-language vaccine against diphtheria, tetanus, pertussis, and polio.[4][1]
The authorisation holders are GlaxoSmithKline Biologicals S.A. and Sanofi Pasteur Europe.[4][1]
The registry classifies this substance as part of fixed combinations in three product records, and paediatric formulations exist in two product records.[4][1]
Tetanus toxoid is a detoxified form of the toxin produced by the bacterium Clostridium tetani. When injected, it trains the immune system to recognise and neutralise the real toxin without causing the disease itself. In the combination vaccines listed here, the toxoid is adsorbed onto aluminium hydroxide, which acts as an adjuvant to strengthen the immune response. The trial records do not provide further mechanistic detail beyond this known role as a vaccine antigen.[4]
As a component of combination vaccines, tetanus toxoid contributes to protection against tetanus. In the clinical trials reviewed, the vaccines containing it appear in studies for:
In two further trials, the combination vaccine containing tetanus toxoid is used as a control or auxiliary product rather than being the substance under investigation.[2][5]
The pharmaceutical form recorded for the products containing this substance is a suspension for injection. The route of administration is intramuscular, meaning the injection is given into a muscle. Some records also list intravenous and intramuscular injection routes for other products in the same trials, but the tetanus toxoid-containing vaccines are given intramuscularly.[4][1]
Five clinical trial records involve products containing tetanus toxoid adsorbed on aluminium hydroxide, hydrated. The substance is listed as an auxiliary medicine in two trials, as the test product in one trial, and as a placebo in one trial.[1]–[5]
The trials span several disease areas. One Phase 1 trial in meningococcal infections enrolled 703 participants and compared different meningococcal vaccine formulations.[4] A Phase 3 trial in pertussis enrolled 138 participants and examined whether maternal vaccination during pregnancy affects children's immunity at age four.[1] A Phase 1 trial in generalised and ocular myasthenia gravis enrolled 135 participants and tested the investigational drug IM-101, with the tetanus toxoid-containing vaccine serving as a control.[2] A Phase 1/2 gene therapy trial in X-linked hyper-IgM syndrome type 1 enrolled 6 participants.[3] A Phase 2 trial in complement-mediated kidney disease enrolled 45 participants and tested ADX-038.[5]
Three trials are completed and two are authorised, meaning they have received regulatory approval to proceed but have not yet reported results. The phases range from Phase 1 to Phase 3. The largest trial is the Phase 1 meningococcal study with 703 participants, and the smallest is the Phase 1/2 hyper-IgM study with 6 participants.[1]–[5]
The meningococcal trial measures safety and reactogenicity through solicited and unsolicited adverse events, as well as immune responses using human serum bactericidal assay titres against meningococcal serogroups A, C, W, Y, and B indicator strains.[4] The pertussis trial measures pertussis toxin-specific IgG antibody concentrations in children at four years of age.[1] The myasthenia gravis trial measures treatment-emergent adverse events and changes in the Myasthenia Gravis Activities of Daily Living score.[2] The hyper-IgM trial measures dose-limiting toxicities.[3] The kidney disease trial measures treatment-emergent adverse events.[5]
The clinical trial records do not provide safety data for the tetanus toxoid-containing vaccines. The trials report adverse events as outcomes, but no results are included in the registry data reviewed here.
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