NCT05519839Phase 2Completed

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

Study sponsor: Novavax

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-07-25Actual

Enrollment · participants1579Actual

Source updated2024-07-16Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

COVID-19; Influenza

Treatments or interventions studied

qNIV Vaccine with Matrix-M AdjuvantDrug
Influenza VaccineDrug
CIC Vaccine with Matrix-M AdjuvantDrug
SARS-CoV-2 rS Vaccine with Matrix-M AdjuvantDrug

Primary outcomes · main study measures

Read the study measures

measure: Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs); description: Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.; timeFrame: Day 0 to Day 7; measure: Part 1 and Part 2 : Percentage of participants with all AEs; description: Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.; timeFrame: Day 0 to Day 21; measure: Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs); description: Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination; timeFrame: Day 0 to Day 182

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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