Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study
Background. A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. Methods. This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assig...
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th-mahidol.872762023-06-20T12:28:41Z Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study Capeding M.R. Mahidol University Medicine Background. A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. Methods. This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination. Results. In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed. Conclusions. Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV. 2023-06-20T05:28:41Z 2023-06-20T05:28:41Z 2022-07-15 Article Journal of Infectious Diseases Vol.226 No.2 (2022) , 308-318 10.1093/infdis/jiaa770 15376613 00221899 33351072 2-s2.0-85126200333 https://repository.li.mahidol.ac.th/handle/123456789/87276 SCOPUS |
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Medicine Capeding M.R. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
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Background. A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. Methods. This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination. Results. In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed. Conclusions. Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV. |
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Mahidol University |
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Mahidol University Capeding M.R. |
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Capeding M.R. |
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Capeding M.R. |
title |
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
title_short |
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
title_full |
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
title_fullStr |
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
title_full_unstemmed |
Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study |
title_sort |
safety and immunogenicity of a new inactivated polio vaccine made from sabin strains: a randomized, double-blind, active-controlled, phase 2/3 seamless study |
publishDate |
2023 |
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https://repository.li.mahidol.ac.th/handle/123456789/87276 |
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1781413837456539648 |