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NCT06291857Not yet recruiting

A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine

A Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety and Immunogenicity of a SARS CoV 2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix-M™ Adjuvant in Participants ≥ 50 Years of Age
NovavaxPhase 2/3ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
COVID-19
Drug/Device/Intervention
CIC Vaccine Co-formulated tNIV2 , SARSCoV-2 rS and Matrix-M Adjuvant
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Novavax
Timeline & enrollment
Phase
Phase 2/3
Start date
Aug 30, 2024
End date
Apr 09, 2025
Enrollment
4000 participants
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
COVID-19, virus identifiedCOVID-19, virus not identifiedCoronavirus infection, unspecified siteViral infection, unspecifiedRift Valley fever
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06291857
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.