Healthy Adults
Conditions
Keywords
Influenza vaccination
Brief summary
The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus). This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison. Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.
Interventions
BIOLOGICALVaccine Candidate #1
Investigational influenza Vaccine
BIOLOGICALVaccine Candidate #2
Investigational influenza Vaccine
BIOLOGICALVaccine Candidate #3
Investigational Influenza Vaccine
BIOLOGICALVaccine Candidate #4
Investigational Influenza Vaccine
BIOLOGICALVaccine Candidate #5
Investigational Influenza Vaccine
BIOLOGICALVaccine Candidate #6
Investigational Influenza Vaccine
BIOLOGICALTIV1 or TIV2
Licensed influenza vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion criteria
* Tested positive for influenza ≤5 months (150 days) prior to Visit 1 (Day 1). * Vaccination with any investigational or licensed influenza vaccine ≤5 months (150 days) before Visit 1 (Day 1). * Receipt of antiviral therapies for influenza (eg, Tamiflu) ≤5 months (150 days) prior to Visit 1 (Day 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting prespecified local reactions following vaccination | Within 7 days after vaccination |
| Percentage of participants reporting prespecified systemic events following vaccination. | Within 7 days after vaccination |
| Percentage of participants reporting adverse events (AEs) following vaccination. | Within 1 month after vaccination |
| Percentage of participants reporting serious adverse events (SAEs) following vaccination. | Within 6 months after vaccination |
| Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination. | Within 6 months after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine. | Before vaccination and at 4 weeks after vaccination |
| Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine | Before vaccination to 4 weeks after vaccination |
| Percentage of participants with satisfactory antibody response to the vaccine. | Before vaccination to 4 weeks after vaccination |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed