A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine - Trial NCT06291857
Access comprehensive clinical trial information for NCT06291857 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Novavax and is currently Not yet recruiting. The study focuses on COVID-19. Target enrollment is 4000 participants.
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Study Focus
CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant
Interventional
biological
Sponsor & Location
Novavax
Timeline & Enrollment
Phase 2/3
Aug 30, 2024
Apr 09, 2025
Primary Outcome
Safety- Solicited AEs over 7 days post-vaccination, For both local injection site symptoms/signs and systemic symptoms/signs,Safety-Unsolicited AEs over 21 days post-vaccination and medically attended adverse events (MAAEs).,Safety-Treatment-related MAAEs, serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis) over 6 months
Summary
The goal of this Phase 3 study is to compare the effectiveness, safety, and side effects of
 the CIC vaccine with approved flu vaccines and the Novavax COVID-19 Vaccine with adjuvant.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06291857
Non-Device Trial