A Phase 2 interventional study of SCTV01C and Sinopharm inactivated COVID-19 vaccine in COVID-19 and SARS-CoV-2 Infection, sponsored by Sinocelltech Ltd.. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Sinocelltech Ltd. (part of Sinocelltech Group Limited) · Phase 2, Interventional, and Prevention
The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sinocelltech Ltd. is the lead sponsor of 81 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Biological: SCTV01C
Biological: Sinopharm inactivated COVID-19 vaccine
Biological: SCTV01C
Biological: Comirnaty
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Cohort 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 28 after the study vaccination
Cohort 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 0 to Day 180 after the study vaccination
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SCTV01C vaccine