NCT04728347Phase 2Terminated

Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

Study sponsor: Arcturus Therapeutics, Inc.

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 completion2021-12-28Actual

Enrollment · participants65Actual

Source updated2024-12-30Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

SARS-CoV-2

Treatments or interventions studied

ARCT-021Biological

Primary outcomes · main study measures

Read the study measures

measure: Number of Participants With Solicited Local and Systemic Adverse Events; description: Solicited local adverse events were defined as pain, tenderness, erythema, or swelling at the injection site. Solicited systemic adverse events were defined as fever, fatigue, headache, chills, nausea, vomiting, diarrhoea, myalgia, and arthralgia. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.; timeFrame: Up to Day 7 (7 days after vaccine administration); measure: Number of Participants With Unsolicited Adverse Events; description: Unsolicited adverse events were defined as any spontaneously occurring adverse event (serious and non-serious). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.; timeFrame: Up to Day 29 (28 days after vaccine administration); measure: Number of Participants With Serious Adverse Events (SAEs), Unsolicited Adverse Events Associated With New Onset of Chronic Disease (NOCD) or Medically Attended Adverse Events (MAAEs); description: SAEs were defined as any event that resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was an important medical event. A NOCD was defined as a MAAE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. A MAAE was an adverse event that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.; timeFrame: Up to a maximum of approximately 12 months

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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