Publication:
Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial

Simple item page
dc.contributor.authorAbarca, Katia
dc.contributor.authorIturriaga, Carolina
dc.contributor.authorUrzúa, Marcela
dc.contributor.authorLe Corre, Nicole
dc.contributor.authorPineda, Augusto
dc.contributor.authorFernández, Carolina
dc.contributor.authorDomínguez, Angélica
dc.contributor.authorGonzález, Pablo
dc.contributor.authorBueno, Susan
dc.contributor.authorDonato, Paulina
dc.contributor.authorEspinoza, Pilar
dc.contributor.authorFuentes, Daniela
dc.contributor.authorGonzález, Marcela
dc.contributor.authorGuzmán, Paula
dc.contributor.authorMuñoz Venturelli, Paula
dc.contributor.authorPérez, Carlos
dc.contributor.authorPotin, Marcela
dc.contributor.authorRojas, Álvaro
dc.contributor.authorGonzález, José
dc.contributor.authorGálvez, Nicolás
dc.contributor.authorAguirre, Francisca
dc.contributor.authorAljaro, Sofía
dc.contributor.authorBátiz, Luis
dc.contributor.authorCampisto, Yessica
dc.contributor.authorCepeda, Mariela
dc.contributor.authorCortés, Aarón
dc.contributor.authorLópez, Sofía
dc.contributor.authorPérez, María
dc.contributor.authorSchilling, Andrea
dc.contributor.authorKalergis, Alexis
dc.contributor.authorOn behalf of the CoronaVac CL Study Group
dc.date.accessioned2023-05-05T16:15:31Z
dc.date.available2023-05-05T16:15:31Z
dc.date.issued2022
dc.description.abstractSeveral vaccines have been developed to control the COVID-19 pandemic. CoronaVac®, an inactivated SARS-CoV-2 vaccine, has demonstrated safety and immunogenicity, preventing severe COVID-19 cases. We investigate the safety and non-inferiority of two immunization schedules of CoronaVac® in a non-inferiority trial in healthy adults. A total of 2302 healthy adults were enrolled at 8 centers in Chile and randomly assigned to two vaccination schedules, receiving two doses with either 14 or 28 days between each. The primary safety and efficacy endpoints were solicited adverse events (AEs) within 7 days of each dose, and comparing the number of cases of SARS-CoV-2 infection 14 days after the second dose between the schedules, respectively. The most frequent local AE was pain at the injection site, which was less frequent in participants aged ≥60 years. Other local AEs were reported in less than 5% of participants. The most frequent systemic AEs were headache, fatigue, and myalgia. Most AEs were mild and transient. There were no significant differences for local and systemic AEs between schedules. A total of 58 COVID-19 cases were confirmed, and all but 2 of them were mild. No differences were observed in the proportion of COVID-19 cases between schedules. CoronaVac® is safe, especially in ≥60-year-old participants. Both schedules protected against COVID-19 hospitalization.
dc.identifier.citationAbarca K, Iturriaga C, Urzúa M, Le Corre N, Pineda A, Fernández C, Domínguez A, González PA, Bueno SM, Donato P, Espinoza P, Fuentes D, González M, Guzmán P, Muñoz-Venturelli P, Pérez CM, Potin M, Rojas Á, González-Aramundiz JV, Gálvez NMS, Aguirre-Boza F, Aljaro S, Bátiz LF, Campisto Y, Cepeda M, Cortés A, López S, Pérez ML, Schilling A, Kalergis AM, On Behalf Of The CoronaVac Cl Study Group. Safety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial. Vaccines (Basel). 2022 Jul 6;10(7):1082. doi: 10.3390/vaccines10071082
dc.identifier.doihttps://doi.org/10.3390/vaccines10071082
dc.identifier.urihttps://repositorio.udd.cl/handle/11447/7465
dc.language.isoen
dc.subjectCOVID-19
dc.subjectCoronaVac
dc.subjectSARS-CoV-2
dc.subjectImmunization schedules
dc.subjectPhase III clinical trial
dc.subjectVaccines
dc.titleSafety and Non-Inferiority Evaluation of Two Immunization Schedules with an Inactivated SARS-CoV-2 Vaccine in Adults: A Randomized Clinical Trial
dc.typeArticle
dcterms.accessRightsAcceso Abierto
dcterms.sourceVaccines
dspace.entity.typePublication

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
2. Safety and Non-Inferiority Evaluation of Two ImmunizationSchedules.pdf
Size:
1.1 MB
Format:
Adobe Portable Document Format
Description:
Texto completo
Download
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.63 KB
Format:
Item-specific license agreed upon to submission
Description:
Download

Collections

Artículos Medicina y Ciencias de la Salud

Implementado por OpenGeek Services