Status:
COMPLETED
Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old
Lead Sponsor:
FluGen Inc
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza Vaccine
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a heal...
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a heal...
Eligibility Criteria
Inclusion
- Subjects must be willing and able to provide written informed consent.
- Cohort 1: age 50-64 years at time of enrollment; Cohorts 2 and 3: age 65 to 85 years at time of enrollment (signing of informed consent form).
- Subject willing to adhere to the requirements of the study and willing and able to communicate with the Investigator and understand the requirements of the study
- Healthy adults and those with stable chronic conditions as determined by medical history, physical examination, vital signs, clinical safety laboratory examinations and clinical judgment of the investigator to be eligible for study inclusion.
- Women of child-bearing potential must agree to abstain from sexual intercourse or to correctly use an acceptable method of contraception from 30 days prior to vaccination until 30 days after the last study vaccination.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours prior to vaccination with investigational product.
Exclusion
- Any acute or chronic physical or mental condition that would limit the subject's ability to complete the study, increase risk of study participation or participant, or may interfere with interpretation of study results as based on the assessment by the Investigator.
- Acute or chronic medical condition or history of a medical condition that, in the opinion of the Investigator, would render the study procedures unsafe or would interfere with the evaluation of the responses.
- Abnormal screening hematology or chemistry value per the FDA Guidance: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.
- Currently receiving, or planned to receive during the study, any immunosuppressive therapy.
- Had a flu-like illness, influenza treatment, influenza vaccination, or prophylactic influenza viral drug administered in the previous 6 months before investigational product administration.
- Females who are pregnant or nursing; non-vasectomized males, with female partners of child-bearing potential, who are unwilling to use a highly effective form of contraception from the time of enrollment through at least 28 after administration of the investigational product.
- History of receipt of any investigational vaccine within 28 days of visit 1 or investigational drug within the past six months. An exception is made for receipt of a Covid-19 vaccine whether licensed or under emergency use authorization (EUA) as long as the second dose was given at least 28 days prior to dosing with investigational vaccine.
- Acute febrile illness within 72 hours prior to investigational product vaccination
- Receipt of blood/plasma products or immunoglobulin within 6 months before administration of the investigational product or planned for during the period of study participation.
- Planned donation of blood or blood product of at least approximately 1 pint within 3 months after investigational product administration.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04785794
Start Date
June 30 2021
End Date
November 30 2021
Last Update
June 15 2023
Active Locations (3)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Accel Clinical
DeLand, Florida, United States, 32127
3
Johnson County Clin Trials
Lenexa, Kansas, United States, 66219