A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine,

Clinical Trial Summary

The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (>=) 18 to less than or equal to (<=) 45 years of age.

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06280144` - Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine	Phase 4
Recruiting	`NCT05056519` - The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine	Phase 1
Withdrawn	`NCT02713061` - A Phase 2 Study of a Subcutaneous Injection of TAK-850 in Healthy Adult Participants	Phase 2
Not yet recruiting	`NCT05284851` - The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine	Phase 2

See also

Status

Clinical Trial

Phase

Recruiting

NCT06280144 - Post-marketing Study of Lyophilized Nasal Spray Live Attenuated Influenza Vaccine

Phase 4

Recruiting

NCT05056519 - The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Phase 1

Withdrawn

NCT02713061 - A Phase 2 Study of a Subcutaneous Injection of TAK-850 in Healthy Adult Participants

Phase 2

Not yet recruiting

NCT05284851 - The Safety and Immunogenicity Evaluation of Live Attenuated Influenza Vaccine

Phase 2

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	NCT05901636
Study type	Interventional
Source	Janssen Vaccines & Prevention B.V.
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	May 17, 2023
Completion date	August 30, 2024

A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms