Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age

Figures

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  Figure 1.. Disposition of participants. Notes: IPV = inactivated polio vaccine; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV.

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  Figure 2.. Incidence of fever after 3-dose primary vaccination. The incidence of fever in categories as indicated in green, yellow, red, black and gray, after the 1st, 2nd and 3rd immunization as well as the cumulative incidence, is shown for the different dose levels of sIPV and for cIPV. IPV = inactivated poliovirus vaccine; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV.

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  Figure 3.. Anti-poliovirus seroconversion rates (with 95% CI) 28 days after dose 3 – per protocol immunogenicity set. Seroconversion rates at 28 days after the 3rd immunization for Salk and Sabin virus types 1, 2 and 3 are plotted for each group. Seroconversion was determined as described in the Methods. IPV = inactivated poliovirus vaccine; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV; CI = confidence interval.

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  Figure 4.. Anti-poliovirus seroprotection rates (with 95% CI) 28 days post-dose 3 – per protocol immunogenicity set. Seroprotection rates at 28 days after the 3rd immunization for Salk and Sabin virus types 1, 2 and 3 are plotted for each group. Seroprotection was determined as described in the Methods. IPV = inactivated poliovirus vaccine; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV; CI = confidence interval.

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  Figure 5.. Anti-poliovirus geometric mean titers (with 95% CI) 28 days after dose 3 – per protocol immunogenicity set. Neutralizing antibody titers at 28 days after the 3rd immunization for Salk and Sabin virus types 1, 2 and 3 are plotted as geometric mean titers for each group. Neutralizing antibody titers were determined as described in the Methods. IPV = inactivated poliovirus vaccine; GMT = geometric mean titer; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV; CI = confidence interval.

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  Figure 6.. Geometric mean poliovirus-neutralizing antibody titers (with 95% CI) 28 days post-dose 3 according to pre-vaccination serostatus–per protocol immunogenicity set. Neutralizing antibody titers at 28 days after the 3rd immunization for Salk and Sabin virus types 1, 2 and 3 are plotted as geometric mean titers for each group for participants that were seronegative at baseline (open circles) or seropositive at baseline (full circles). Neutralizing antibody titers were determined as described in the Methods. IPV = inactivated poliovirus vaccine; sIPV = Sabin-IPV; LD = low dose; ID = intermediate dose; HD = high dose; cIPV = conventional Salk-IPV; CI = confidence interval; ULOQ, upper limit of quantification; SP = seroprotection threshold.