Grippe, Influenza, Vaccines
Conditions
Keywords
Flu, Pandemic influenza, RNA vaccine
Brief summary
The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: * between the ages of 18 to 49 years old or 65 to 84 years old. * willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures. * healthy as confirmed by medical history, physical examinations, and the study doctor. * capable of signing informed consent. Participants will receive either: * the pdmFlu vaccine, * a licensed influenza vaccine * a placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.
Interventions
BIOLOGICALpdmFlu vaccine
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection
BIOLOGICALLicensed influenza vaccine
Intramuscular injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: \- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Key
Exclusion criteria
\- Does not meet seasonal influenza vaccine requirements per cohort.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants by age group reporting local reactions | For 7 days after vaccination |
| Percentage of participants by age group reporting systemic events | For 7 days after vaccination |
| Percentage of participants by age group reporting adverse events | From vaccination to 4 weeks after each vaccination |
| Percentage of participants by age group reporting serious adverse events | From vaccination to 6 months after last vaccination or through the last visit, whichever is longer |
| Percentage of participants by age group reporting medically attended adverse events | From vaccination to 6 months after last vaccination or through the last visit, whichever is longer |
| Percentage of participants by age group with abnormal hematology and chemistry laboratory values | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
| Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments | Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
| Percentage of participants by age group with new clinically significant ECG abnormalities | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
| Percentage of participants by age group with new troponin I abnormalities | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Proportion of participants by age group achieving HAI seroconversion | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Proportion of participants by age group with HAI titer >=1:40 | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed