Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants : a phase III, randomized trial
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2020 |
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| Enthalten in: |
The Journal of infectious diseases - (2020) vom: 04. Mai |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Salamanca de la Cueva, Ignacio [VerfasserIn] |
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| Links: |
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| Themen: |
Immunogenicity |
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| Anmerkungen: |
Date Revised 27.02.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1093/infdis/jiaa210 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM309487560 |
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| 100 | 1 | |a Salamanca de la Cueva, Ignacio |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants |b a phase III, randomized trial |
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| 500 | |a published: Print-Electronic | ||
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| 520 | |a © The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: The 3 PCV-free HRV lots demonstrated consistency and PCV-free HRV was non-inferior compared to HRV in terms of immunogenicity | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a immunogenicity | |
| 650 | 4 | |a porcine circovirus type 1 | |
| 650 | 4 | |a porcine circovirus-free | |
| 650 | 4 | |a rotavirus vaccine | |
| 650 | 4 | |a safety | |
| 700 | 1 | |a Pahud, Barbara |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Li-Min |e verfasserin |4 aut | |
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