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POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS is an inactivated poliovirus vaccine component. It is part of Infanrix hexa, a fixed combination vaccine authorised in the European Union under authorisation record EU/1/00/152/001.[3] The marketing authorisation holder is GlaxoSmithKline Biologicals S.A.[3] Infanrix hexa contains inactivated poliovirus types 1 (Mahoney strain), 2 (MEF-1 strain) and 3 (Saukett strain), all produced on Vero cells, together with antigens against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b.[3] In the clinical trials listed on this page, Infanrix hexa serves as an auxiliary vaccine in two trials, meaning it is used as a supporting or comparison medicine rather than as the main substance under investigation.[3]
The poliovirus type 3 (Saukett strain) component is inactivated, which means the virus has been killed so it cannot cause disease. When injected, the inactivated virus still triggers the immune system to produce antibodies against poliovirus type 3. These antibodies protect against paralysis caused by wild poliovirus type 3 if the vaccinated person is later exposed to it. The Vero cell line is used to grow the virus during manufacturing before it is inactivated.
As part of Infanrix hexa, the poliovirus type 3 (Saukett) component contributes to protection against poliomyelitis. In the trials listed here, Infanrix hexa is used as a background or comparison vaccine, not as the main study drug. The conditions being studied in those trials are:
Infanrix hexa is provided as a powder and suspension for suspension for injection.[3] It is given by intramuscular injection or intramuscular use.[3] A paediatric formulation is available in one product record.[3]
Five clinical trials in the registry list Infanrix hexa among their interventions. In all five, Infanrix hexa is a background, auxiliary or comparison vaccine rather than the substance being tested. The trials span phases 1, 2 and 3, and their statuses are either completed or authorised. The largest trial enrolled 703 participants and the smallest enrolled 6 participants.[3][2]
The trials enrol different populations. The meningococcal vaccine trial enrolled 703 participants, the pertussis immunity trial enrolled 240 pregnant women and their infants, the myasthenia gravis trial enrolled 135 adults, the HIGM1 trial enrolled 6 patients with X-linked hyper-IgM syndrome type 1, and the kidney disease trial enrolled 45 participants with complement-mediated kidney disease.[1]–[5]
The trials measure different outcomes depending on their purpose. The meningococcal trial measured safety events and immune responses (hSBA titres) against meningococcal serogroups A, C, W, Y and B indicator strains.[3] The pertussis trial measured the magnitude of antibody responses to pertussis vaccination in infants.[4] The myasthenia gravis trial measured treatment-emergent adverse events and changes in myasthenia gravis scores.[1] The HIGM1 trial measured dose-limiting toxicities.[2] The kidney disease trial measured the incidence and severity of treatment-emergent adverse events.[5]
The supplementary source provided does not report side effects of the inactivated poliovirus type 3 (Saukett strain) vaccine component. It describes a case of vaccine-derived poliovirus type 3 in an immunodeficient infant, but this relates to live-attenuated oral polio vaccine, not the inactivated vaccine component described on this page.[6]
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