Status:
COMPLETED
Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza Immunization
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, admin...
Detailed Description
This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.
Eligibility Criteria
Inclusion
- Aged 18 years or older on the day of inclusion.
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration
- A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention.
- Informed consent form has been signed and dated.
Exclusion
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
- Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
- Have any diagnosis, current or past, of autoimmune disease.
- Body mass index of 40 kg/m2 or higher.
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
- Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2024
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT05426174
Start Date
June 9 2022
End Date
January 3 2024
Last Update
September 15 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
AES - DRS - Optimal Research_Site 8400007
Huntsville, Alabama, United States, 35802
2
Central Phoenix Medical Clinic, LLC_Site: 8400010
Phoenix, Arizona, United States, 85020
3
Optimal Research San Diego, LLC_Site: 8400009
San Diego, California, United States, 92108
4
AES - DRS - Optimal Research_Site 8400002
Melbourne, Florida, United States, 32934-8172