| Autor: |
Cueva, Ignacio Salamanca de la, Pahud, Barbara, Huang, Li-Min, Leonardi, Michael, Garcia-Sicilia, José, Céspedes, Javier, Abdelnour, Arturo, Tamura, Tsuyoshi, Kuroki, Haruo, Chiu, Nan-Chang, Virta, Miia, Kokko, Satu, Horn, Michael, Panzer, Falko, Kim, Jong-Hyun, Lee, Jin, Moerman, Leentje, Debacq, Christophe, Parra, Jose, Ugarte, Ana |
| Zdroj: |
Journal of Infectious Diseases; 6/15/2022, Vol. 225 Issue 12, p2106-2115, 10p |
| Abstrakt: |
Background: Porcine circovirus type 1 (PCV-1) material was detected in the human rotavirus vaccine (HRV) in 2010. In this study (NCT02914184) we compared immunogenicity and safety of the PCV-free HRV vaccine (PCV-free HRV) with HRV. PCV-free HRV is an HRV with no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.Methods: Healthy infants 6-12 weeks of age were randomized (1:1:1:1) to receive 2 doses of 1 of the 3 lots of PCV-free HRV or HRV. The study objectives were to demonstrate lot-to-lot consistency of the PCV-free HRV and non-inferiority of PCV-free HRV as compared to HRV in terms of immunogenicity, 1-2 months post-dose 2. Reactogenicity and safety were also assessed.Results: Overall, 1612 infants were enrolled and 1545 completed the study. Study objectives were demonstrated since the pre-defined criteria were met. Among participants receiving PCV-free HRV and HRV, 79.27% and 81.76% seroconverted and geometric mean concentrations were 159.5 and 152.8 U/mL, respectively. The incidences of adverse events and serious adverse events were similar between the pooled PCV-free HRV and HRV groups.Conclusions: The 3 PCV-free HRV lots demonstrated consistency and PCV-free HRV was non-inferior compared to HRV in terms of immunogenicity. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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