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The combined potency loss rate estimates of VZV (Oka/Merck) in both, hydrolyzed porcine gelatin (SOL-U-PRO), as well as recombinant human gelatin (FG-5001) stabilized, experimental refrigerator-stable varicella vaccine formulations stored at -15°C and 2–8°C for 24 months, and at 15°C for 12 months, respectively. The potency loss rates are in log10 PFU per month. |
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| Potency Loss Rate Estimates (95%CI) |
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| Storage Temperature |
SOL-U-PRO |
FG-5001 |
Combined |
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| -15°C |
0.000 (-0.004,0.005) |
0.000 (0.005, 0.005) |
0.000 (-0.003, 0.004) |
| 2–8°C |
0.005 (0.000, 0.010) |
0.005 (0.000, 0.010) |
0.005 (0.001, 0.009) |
| 15°C |
0.033 (0.017, 0.049) |
0.033 (0.017, 0.048) |
0.033 (0.022, 0.044) |
Liska et al. Journal of Immune Based Therapies and Vaccines 2007 5:4 doi:10.1186/1476-8518-5-4 |
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