What side effects are associated with this type of intervention?

Common side effects of influenza vaccines, including the Quadrivalent Influenza modRNA Vaccine, typically include mild to moderate reactions such as soreness at the injection site, headache, muscle aches, fever, and fatigue. These side effects are generally short-lived. Antiviral drugs like zanamivir and laninamivir, used for flu prevention and treatment, can cause gastrointestinal side effects and, in some cases, bronchospasm, particularly in individuals with a history of respiratory issues. Overall, these treatments are well-tolerated, with serious adverse events being rare.

What prior FDA approvals exist?

The FDA has approved several treatments for influenza, including antiviral drugs like oseltamivir (Tamiflu), zanamivir (Relenza), and baloxavir marboxil (Xofluza). These drugs work by inhibiting viral replication. While there are no FDA-approved influenza vaccines using modified RNA technology similar to the Quadrivalent Influenza modRNA Vaccine, the success of mRNA vaccines for COVID-19 (e.g., Pfizer-BioNTech and Moderna) suggests potential for future approvals in this area. Traditional flu vaccines, such as inactivated and live attenuated vaccines, remain the primary FDA-approved options for influenza prevention.

What other types of research exist?

Promising novel alternatives to the Quadrivalent Influenza modRNA Vaccine for flu patients in 2024 include: 1) Plant-based influenza vaccines, which utilize plant-based transient expression systems to produce virus-like particles that have shown safety and immunogenicity in clinical trials. 2) Adenovirus-based quadrivalent influenza vaccines, which have been modeled in animal studies and demonstrated favorable immune responses compared to traditional vaccines. Both alternatives represent innovative approaches in vaccine development and could offer effective protection against influenza.

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Virus Therapy

modRNA Vaccine for Flu

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

estrogen positive

Be older than 18 years old

Must not have

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.

Allergy to egg proteins (egg or egg products) or chicken proteins.

Timeline

Screening 3 days

Treatment 3 months

Follow Up 3 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new type of flu shot that uses modified RNA to protect against four strains of the flu. It targets healthy adults aged 18 and older. The vaccine works by teaching the immune system to recognize and fight the flu virus.

Who is the study for?

Adults over 18 who are healthy and have had a recent colonoscopy can join this flu vaccine study. They must be able to follow the study plan and give informed consent. People with egg or chicken protein allergies, severe reactions to vaccines, or certain medical or psychiatric conditions cannot participate.

What is being tested?

This Phase 3 trial is testing a new quadrivalent influenza modRNA vaccine against the standard flu shot in adults. Participants will receive one dose of either the new vaccine or the standard one, and researchers will compare their effectiveness and safety.

What are the potential side effects?

Potential side effects from both vaccines may include pain at injection site, fatigue, headache, muscle pain, feverish feelings, joint pain; however specific side effects for the modRNA vaccine are not detailed as it's under evaluation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is estrogen receptor positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

You have a medical or mental health condition that might make it too risky for you to participate in the study. This includes having had thoughts of suicide within the past year or showing abnormal results in lab tests.

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You are allergic to eggs or chicken.

Timeline

Screening ~ 3 days1 visit

Treatment ~ 3 months1 visit

Follow Up ~ 3 months1 visit

Screening ~ 3 days

Treatment ~ 3 months

Follow Up ~3 months

This trial's timeline: 3 days for screening, 3 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants reporting adverse events, 18 through 64 years of age and ≥65 years of age separately and combined

Percentage of participants reporting local reactions, 18 through 64 years of age and ≥65 years of age separately

Percentage of participants reporting serious adverse events, 18 through 64 years of age and ≥65 years of age separately and combined

+3 more

Secondary study objectives

Difference in percentage of participants achieving seroconversion for each strain between qIRV recipients and QIV recipients, 18 through 64 and ≥65 years of age separately

Geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers for each strain in qIRV recipients compared to QIV recipients, 18 through 64 and ≥65 years of age separately

HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and ≥65 years of age separately

+8 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041

COVID-19 Infection

Upper Respiratory Infection

Cardiovascular Accident (CVA), Unspecified Mechanism

Left partial cranial nerve III palsy

Acute Hyperkalemia

Shortness of Breath

Acute pulmonary embolism and acute deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine

Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Quadrivalent influenza modRNA vaccine, ≥65 years of ageExperimental Treatment1 Intervention

Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age

Group II: Quadrivalent influenza modRNA vaccine, 18 through 64 years of ageExperimental Treatment1 Intervention

Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age

Group III: Quadrivalent influenza vaccine, 18 through 64 years of ageActive Control1 Intervention

Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age

Group IV: Quadrivalent influenza vaccine, ≥65 years of ageActive Control1 Intervention

Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The quadrivalent influenza modRNA vaccine works by using modified RNA to instruct cells to produce antigens that trigger an immune response against four strains of the influenza virus. This approach helps the immune system recognize and fight the virus more effectively. Other common treatments include inactivated vaccines, which use killed virus particles, and recombinant hemagglutinin vaccines, which use viral proteins to stimulate immunity. These mechanisms are crucial for flu patients as they prepare the immune system to quickly identify and combat the influenza virus, thereby reducing the severity and duration of the illness.

Recombinant hemagglutinin influenza vaccine provides broader spectrum protection.Repeated Low-Dose Influenza Virus Infection Causes Severe Disease in Mice: a Model for Vaccine Evaluation.MF59 and Pam3CSK4 boost adaptive responses to influenza subunit vaccine through an IFN type I-independent mechanism of action.