A study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease
RecruitingA study to evaluate the safety of ADX-038 in patients with complement-mediated kidney disease
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Poliovirus (inactivated) type 3 (saukett strain) is a vaccine antigen derived from inactivated poliovirus type 3, specifically the Saukett strain.[5] It is an ingredient substance used in combination vaccines that protect against poliomyelitis and other infections.
As an inactivated poliovirus antigen, the substance is designed to stimulate the immune system to produce antibodies against poliovirus type 3 without causing the disease itself. In the clinical trials listed here, it is typically combined with other vaccine antigens such as diphtheria, tetanus, and pertussis components, so the immune response targets several pathogens at once.[3] The Saukett strain is one of three poliovirus strains (types 1, 2, and 3) used in inactivated polio vaccines; the other strains in these combinations are the Mahoney strain (type 1) and the MEF-1 strain (type 2).[3]
The substance is formulated as a suspension for injection and is given by intramuscular injection.[3] In the registered trials, the vaccines containing this antigen are administered as 0.5 ml doses. One product record indicates a paediatric formulation is available.[3] The route of administration recorded in the registry includes intramuscular, injection, and intramuscular injection.[3]
Four clinical trials involving poliovirus (inactivated) type 3 (saukett strain) are registered. Two completed phase 3 trials focus on pertussis: the MIFI-4Y study followed 138 Finnish children to assess long-term pertussis immunity after maternal vaccination during pregnancy,[3] and the KIM study enrolled 99 healthy adults to test whether a Tdap-IPV booster reduces Bordetella pertussis colonisation after controlled human infection.[1] A phase 2 trial with 750 participants is authorised for meningococcal immunisation in children, toddlers, and infants.[2] Another phase 2 trial with 45 participants, authorised for complement-mediated kidney disease, includes the substance within routine vaccination schedules.[4]
The four trials span phase 2 and phase 3. Both phase 3 trials are completed, while both phase 2 trials are authorised but not yet reporting results in the registry. The largest trial enrolled 750 participants and the smallest enrolled 45 participants.[2][4] The pertussis trials measure antibody responses: the MIFI-4Y study assesses PT-specific IgG antibody geometric mean concentration in children at 4 years of age,[3] and the KIM study measures Bordetella pertussis colonisation rates from nasal wash samples between day 3 and day 28 after challenge.[1]
The supplementary sources provided do not contain specific side effect information for poliovirus (inactivated) type 3 (saukett strain) alone. One of the registered trials, the pentavalent meningococcal vaccine study, lists safety outcomes including solicited injection site reactions, systemic reactions, unsolicited adverse events, and serious adverse events as primary outcomes.[2]
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