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Article: Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study
Title | Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study |
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Authors | |
Keywords | Human rotavirus vaccine Infant Liquid Porcine circovirus-free Reactogenicity Safety |
Issue Date | 24-Jan-2022 |
Publisher | Elsevier |
Citation | Data in Brief, 2022, v. 40, n. 14, p. 2184-2190 How to Cite? |
Abstract | Background: The introduction of rotavirus vaccines in national immunization programs has decreased mortality and hospitalizations due to diarrhea. GSK's live-attenuated, human rotavirus vaccine (HRV) is a 2-dose vaccine for oral administration. Following the detection of porcine circovirus type 1 (PCV-1) in HRV, a PCV-free (no detection of PCV-1 and PCV-2 according to the detection limits of tests used) HRV was developed. The immunogenicity, reactogenicity and safety of a liquid (liq) PCV-free HRV were assessed in two prior studies. The present study aimed to generate additional reactogenicity and safety data. Methods: This phase III, observer-blind, randomized, controlled multi-country study enrolled healthy 6-12-week-old infants. Infants were randomized to receive 2 doses of either the liq PCV-free HRV (N = 677) or the lyophilized (lyo) HRV (N = 674) 1-2 months apart. Solicited adverse events (AEs) were recorded for 8 days after each dose, unsolicited AEs for 31 days and serious AEs (SAEs) from dose 1 until the end of the 6-month safety follow-up. Results: The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4-78.1] and 72.1% [68.6-75.5]). Unsolicited AEs were reported for 29.7% (26.3-33.3) and 30.6% (27.1-34.2) of infants in the liq PCV-free HRV and the lyo HRV group. A total of 39 and 38 infants reported at least one SAE, respectively. The most common SAEs were upper respiratory tract (0.7% and 0.9%) and urinary tract infections (0.9% and 0.6%). One SAE (constipation) in the liq PCV-free HRV group |
Persistent Identifier | http://hdl.handle.net/10722/331436 |
ISSN | 2023 Impact Factor: 1.0 2023 SCImago Journal Rankings: 0.208 |
ISI Accession Number ID |
DC Field | Value | Language |
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dc.contributor.author | Lau, YL | - |
dc.contributor.author | Leung, TF | - |
dc.contributor.author | Cetin, BS | - |
dc.contributor.author | Dinleyici, EC | - |
dc.contributor.author | Huang, LM | - |
dc.contributor.author | Halperin, SA | - |
dc.contributor.author | Hsiao, CC | - |
dc.contributor.author | Tapiero, B | - |
dc.contributor.author | Tipton, M | - |
dc.contributor.author | Campbell, JD | - |
dc.contributor.author | Moerman, L | - |
dc.contributor.author | Povey, M | - |
dc.contributor.author | Bi, D | - |
dc.contributor.author | Singh, T | - |
dc.date.accessioned | 2023-09-21T06:55:43Z | - |
dc.date.available | 2023-09-21T06:55:43Z | - |
dc.date.issued | 2022-01-24 | - |
dc.identifier.citation | Data in Brief, 2022, v. 40, n. 14, p. 2184-2190 | - |
dc.identifier.issn | 2352-3409 | - |
dc.identifier.uri | http://hdl.handle.net/10722/331436 | - |
dc.description.abstract | <p>Background: The introduction of rotavirus vaccines in national immunization programs has decreased mortality and hospitalizations due to diarrhea. GSK's live-attenuated, human rotavirus vaccine (HRV) is a 2-dose vaccine for oral administration. Following the detection of porcine circovirus type 1 (PCV-1) in HRV, a PCV-free (no detection of PCV-1 and PCV-2 according to the detection limits of tests used) HRV was developed. The immunogenicity, reactogenicity and safety of a liquid (liq) PCV-free HRV were assessed in two prior studies. The present study aimed to generate additional reactogenicity and safety data. Methods: This phase III, observer-blind, randomized, controlled multi-country study enrolled healthy 6-12-week-old infants. Infants were randomized to receive 2 doses of either the liq PCV-free HRV (N = 677) or the lyophilized (lyo) HRV (N = 674) 1-2 months apart. Solicited adverse events (AEs) were recorded for 8 days after each dose, unsolicited AEs for 31 days and serious AEs (SAEs) from dose 1 until the end of the 6-month safety follow-up. Results: The occurrence of solicited general AEs was comparable between the liq PCV-free HRV and the lyo HRV groups, with irritability/fussiness being the most frequently reported (74.9% [95% confidence interval: 71.4-78.1] and 72.1% [68.6-75.5]). Unsolicited AEs were reported for 29.7% (26.3-33.3) and 30.6% (27.1-34.2) of infants in the liq PCV-free HRV and the lyo HRV group. A total of 39 and 38 infants reported at least one SAE, respectively. The most common SAEs were upper respiratory tract (0.7% and 0.9%) and urinary tract infections (0.9% and 0.6%). One SAE (constipation) in the liq PCV-free HRV group<br></p> | - |
dc.language | eng | - |
dc.publisher | Elsevier | - |
dc.relation.ispartof | Data in Brief | - |
dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
dc.subject | Human rotavirus vaccine | - |
dc.subject | Infant | - |
dc.subject | Liquid | - |
dc.subject | Porcine circovirus-free | - |
dc.subject | Reactogenicity | - |
dc.subject | Safety | - |
dc.title | Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study | - |
dc.type | Article | - |
dc.description.nature | published_or_final_version | - |
dc.identifier.doi | 10.1016/j.vaccine.2022.02.065 | - |
dc.identifier.scopus | eid_2-s2.0-85125292150 | - |
dc.identifier.volume | 40 | - |
dc.identifier.issue | 14 | - |
dc.identifier.spage | 2184 | - |
dc.identifier.epage | 2190 | - |
dc.identifier.eissn | 2352-3409 | - |
dc.identifier.isi | WOS:000822935500009 | - |
dc.identifier.issnl | 2352-3409 | - |