Influenza, Human
Conditions
Keywords
Grippe, Flu, Influenza, Vaccine, RNA vaccine, Self-amplifying
Brief summary
The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: * Are between the age of 18 to 49 years old. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Are healthy as determined by medical history, physical examinations, and the study doctor. * For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children. * Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
Interventions
BIOLOGICALPF-07852352 Influenza saRNA 1
Intramuscular injection
BIOLOGICALPF-07836391 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07836394 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07836395 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07836396 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07867246 Influenza saRNA
Intramuscular injection
BIOLOGICALPlacebo
Intramuscular injection
BIOLOGICALQuadrivalent influenza vaccine (QIV)
Intramuscular injection
BIOLOGICALPF-07871987 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07914705 Influenza saRNA
Intramuscular injection
BIOLOGICALPF-07915048 Influenza saRNA
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 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants 18 to 49 years of age. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * 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. * Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children. * Capable of giving signed informed consent.
Exclusion criteria
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Allergy to egg proteins (egg or egg products) or chicken proteins. * Participant who has had significant exposure to laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection), coronavirus disease 2019 (COVID-19), or influenza in the past 14 days known prior to Visit 1 * Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative. * Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. * Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration. * Any participant who has received or plans to receive a nucleoside-modified messenger ribonucleic acid (modRNA)-platform SARS-CoV-2 vaccine within 60 days of Visit 1 * Previous vaccination with an saRNA or an alphavirus replicon vaccine preparation. * Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. * Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator. * Screening electrocardiogram (ECG) that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results. * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. * Participation in strenuous or endurance exercise through Visit 3. * Prior history of heart disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting local reactions | For 10 days after vaccination | Pain at the injection site, redness, and swelling, as self-reported in electronic diaries. |
| Percentage of participants reporting systemic events | For 10 days after vaccination | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries. |
| Percentage of participants reporting adverse events | From vaccination to 4 weeks after vaccination | As elicited by investigational site staff. |
| Percentage of participants reporting serious adverse events | From vaccination to 6 months after vaccination | As elicited by investigational site staff. |
| Percentage of participants with abnormal hematology and chemistry laboratory values | 2 days after vaccination | As measured at the central laboratory |
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments | Between baseline and 2 days after vaccination | As measured at the central laboratory. |
| Percentage of participants with new electrocardiogram (ECG) abnormalities | 2 days after vaccination | ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist |
| Percentage of participants with new ECG abnormalities | 1 week after vaccination | ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers | At Baseline, and 1-, 2- and 4-weeks after vaccination | As measured at the central laboratory |
| Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint | At Baseline, and 1-, 2- and 4-weeks after vaccination | As measured at the central laboratory |
| Proportion of participants achieving HAI seroconversion for each strain | At 1-, 2-, and 4-weeks after vaccination | As measured at the central laboratory |
| Proportion of participants with HAI titer >=1:40 for each strain | At Baseline, and 1-, 2-, and 4-weeks after vaccination | As measured at the central laboratory |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed