Clinical trial NCT06179446: A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza
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 ADULTS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Grippe
Influenza
Vaccines
Keywords: Flu
Pandemic influenza
RNA vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-12-21
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of participants by age group reporting local reactions
timeFrame: For 7 days after vaccination
measure: Percentage of participants by age group reporting systemic events
timeFrame: For 7 days after vaccination
measure: Percentage of participants by age group reporting adverse events
timeFrame: From vaccination to 4 weeks after each vaccination
measure: Percentage of participants by age group reporting serious adverse events
timeFrame: From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
measure: Percentage of participants by age group reporting medically attended adverse events
timeFrame: From vaccination to 6 months after last vaccination or through the last visit, whichever is longer
measure: Percentage of participants by age group with abnormal hematology and chemistry laboratory values
timeFrame: 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
measure: Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments
timeFrame: 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
measure: Percentage of participants by age group with new clinically significant ECG abnormalities
timeFrame: 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
measure: Percentage of participants by age group with new troponin I abnormalities
timeFrame: 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 outcomes:
measure: Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
timeFrame: 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
measure: Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
timeFrame: 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
measure: Proportion of participants by age group achieving HAI seroconversion
timeFrame: 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
measure: Proportion of participants by age group with HAI titer >=1:40
timeFrame: 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
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: