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NCT06179446 Clinical Trial

A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

Influenza Clinical Trial

Official title:
A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY INDIVIDUALS 18 THROUGH 49 YEARS OF AGE

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06179446
Other study ID # C5561001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date December 13, 2023
Est. completion date November 30, 2024

Study information
Verified date April 2024
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 age of 18 to 49 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 (QIV) - 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 at day 1 and at day 21. 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 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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: - Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• PF-07985819 pdmFlu Vaccine
Intramuscular injection
• Placebo
Intramuscular injection
• Quadrivalent influenza vaccine (QIV)
Intramuscular injection

Locations
Country Name City State
United States Pfizer Clinical Research Unit - New Haven New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants reporting local reactions For 7 days after vaccination
Primary Percentage of participants reporting systemic events For 7 days after vaccination
Primary Percentage of participants reporting adverse events From vaccination to 4 weeks after last vaccination
Primary Percentage of participants reporting serious adverse events From vaccination to 6 months after last vaccination
Primary Percentage of participants reporting medically attended adverse events From vaccination to 6 months after last vaccination
Primary Percentage of participants with abnormal hematology and chemistry laboratory values 1 week after vaccination 1
Primary Percentage of participants with abnormal hematology and chemistry laboratory values 3 weeks after vaccination 1
Primary Percentage of participants with abnormal hematology and chemistry laboratory values 1 week after vaccination 2
Primary Percentage of participants with abnormal hematology and chemistry laboratory values 4 weeks after vaccination 2
Primary Percentage of participants with grading shifts in hematology and chemistry laboratory assessments Between baseline and 1 week after vaccination 1
Primary Percentage of participants with grading shifts in hematology and chemistry laboratory assessments Between baseline and 3 weeks after vaccination 1
Primary Percentage of participants with grading shifts in hematology and chemistry laboratory assessments Between baseline and 1 week after vaccination 2
Primary Percentage of participants with grading shifts in hematology and chemistry laboratory assessments Between baseline and 4 weeks after vaccination 2
Primary Percentage of participants with new clinically significant electrocardiogram (ECG) abnormalities 1 week after vaccination 1
Primary Percentage of participants with new clinically significant ECG abnormalities 3 weeks after vaccination 1
Primary Percentage of participants with new clinically significant ECG abnormalities 1 week after vaccination 2
Primary Percentage of participants with new clinically significant ECG abnormalities 4 weeks after vaccination 2
Primary Percentage of participants with new troponin I abnormalities 1 week after vaccination 1
Primary Percentage of participants with new troponin I abnormalities 3 weeks after vaccination 1
Primary Percentage of participants with new troponin I abnormalities 1 week after vaccination 2
Primary Percentage of participants with new troponin I abnormalities 4 weeks after vaccination 2
Secondary Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2
Secondary Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2
Secondary Proportion of participants achieving HAI seroconversion At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2
Secondary Proportion of participants with HAI titer >=1:40 At Baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2
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