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Poliovirus (inactivated) type 3 (saukett strain)

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About the substance

What is poliovirus (inactivated) type 3 (saukett strain)?

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.

How does it work?

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]

Which conditions is it used or studied for?

  • Pertussis (whooping cough) — studied in two completed trials that investigated maternal immunisation effects on infant immunity and whether booster vaccination reduces Bordetella pertussis colonisation.[3][1]
  • Meningococcal immunisation — the substance appears as an auxiliary component in a trial of an investigational pentavalent meningococcal ABCYW vaccine in children, toddlers, and infants.[2]
  • Complement-mediated kidney disease — the substance is listed among interventions in a phase 2 study of ADX-038, where it appears within routine childhood vaccines given alongside the investigational drug.[4]

How is it given?

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]

What conditions do the clinical trials cover?

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]

What phases and statuses do the trials have?

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]

What side effects are known?

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]

Conditions where Poliovirus (inactivated) type 3 (saukett strain) is being studied

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Trials with Poliovirus (inactivated) type 3 (saukett strain)

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