Safety, Tolerability & Immunogenicity of an Trivalent Inactivated

Clinical Trial Description

1. Assessment of Safety

2. Assessment of Immunogenicity

3. Estimated Enrollment: 100 ;

Study Design

See also
Status	Clinical Trial	Phase
Completed	`NCT02067117` - Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.	Phase 4
Completed	`NCT03160118` - Study of Biomarkers of Immune Activation Associated With Symptoms and Immune Responses After Influenza Vaccination in Adults	Phase 4
Completed	`NCT05642078` - Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT02067117 - Demonstrate the Lot-to-lot Consistency of 3 Consecutive Batches and to Evaluate the Efficacy and Safety of GC FLU®Pre-filled Syringe Injection and 'GC FLU®Injection' Administration.

Phase 4

Completed

NCT03160118 - Study of Biomarkers of Immune Activation Associated With Symptoms and Immune Responses After Influenza Vaccination in Adults

Phase 4

Completed

NCT05642078 - Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03893669
Study type	Interventional
Source	SK Chemicals Co., Ltd.
Contact
Status	Completed
Phase	Phase 1
Start date	September 2012
Completion date	November 2012

Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms