Modified RNA Vaccines for Flu

No longer recruiting at 31 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Disqualifiers: Influenza, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of new RNA-based flu vaccines. Participants will receive a single dose of either a new modRNA flu vaccine (Influenza ModRNA Vaccine) or a standard flu vaccine. The study seeks generally healthy adults who haven't received a flu shot in the past six months. Participants will be involved for about six months, with at least three clinic visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, mRNA-based vaccines for the flu, similar to the modRNA vaccines being tested, showed safety. These vaccines usually cause only mild side effects like headaches, soreness, and muscle aches. Research shows that these side effects are typically temporary and not serious. Another study found that these vaccines cause fewer and less severe reactions in adults compared to other types of vaccines. This suggests that the modRNA vaccines might be well-tolerated and safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Influenza ModRNA Vaccine because it utilizes modified RNA (ModRNA) technology, which is a significant shift from traditional flu vaccines that typically use inactivated or weakened viruses. This ModRNA approach allows the vaccine to instruct cells to produce a protein similar to the influenza virus, prompting an immune response without using the live virus itself. This method can potentially lead to a faster production process and may offer broader protection against various flu strains. Unlike standard flu vaccines requiring seasonal updates, this innovative technology could streamline vaccine development and enhance adaptability to emerging flu variants.

What evidence suggests that this trial's treatments could be effective for flu?

Research has shown that modified RNA (modRNA) vaccines could effectively prevent the flu. In this trial, participants will receive different versions of the Influenza ModRNA Vaccine. One study demonstrated that a flu vaccine called mRNA-1010 created a strong immune response, particularly against certain types of the influenza A virus. Another study found that these vaccines might trigger a stronger immune response than traditional flu vaccines. Traditional flu vaccines often work less than 60% of the time, but modRNA vaccines aim to improve this rate. These early results suggest that modRNA vaccines could offer better protection against the flu. ^{5 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for generally healthy adults over 18 who haven't had a flu shot in the last 6 months. It's to see if new modRNA vaccines are safe and how they affect the body's defense against flu.

Inclusion Criteria

Participants must be generally healthy

I received the flu shot for the 2023-2024 season over 6 months ago.

Exclusion Criteria

I was diagnosed with the flu in the last 6 months.

Immunocompromised individuals with known or suspected immunodeficiency

Receipt of any investigational or licensed influenza vaccines within 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either a modRNA influenza vaccine or an approved influenza vaccine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including local and systemic reactions

6 months

At least 3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Influenza ModRNA Vaccine

Trial Overview

The study tests modified RNA (modRNA) vaccines against influenza, comparing them with an approved Quadrivalent Influenza Vaccine (QIV). Participants will be randomly assigned to receive one dose of either vaccine.

How Is the Trial Designed?

Group I: SSC: Influenza ModRNA Vaccine 9C Experimental Treatment 1 Intervention

\- Single dose on Day 1

Group II: SSC: Influenza ModRNA Vaccine 8C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group III: SSC: Influenza ModRNA Vaccine 7C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group IV: SSC: Influenza ModRNA Vaccine 6C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group V: SSC: Influenza ModRNA Vaccine 5C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group VI: SSC: Influenza ModRNA Vaccine 4C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group VII: SSC: Influenza ModRNA Vaccine 3C Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group VIII: SSB: Influenza ModRNA Vaccine 5B Experimental Treatment 1 Intervention

\- Single dose on Day 1

Group IX: SSB: Influenza ModRNA Vaccine 4B Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group X: SSB: Influenza ModRNA Vaccine 3B Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group XI: SSA: Influenza ModRNA Vaccine 5A Experimental Treatment 1 Intervention

\- Single dose on Day 1

Group XII: SSA: Influenza ModRNA Vaccine 4A Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group XIII: SSA: Influenza ModRNA Vaccine 3A Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group XIV: SSA: Influenza ModRNA Vaccine 2A Experimental Treatment 1 Intervention

\- Single Dose on Day 1

Group XV: SSB: QIV3 Active Control 1 Intervention

\- Single Dose on Day 1

Group XVI: SSC: QIV2 Active Control 1 Intervention

\- Single Dose on Day 1

Group XVII: SSC: QIV3 Active Control 1 Intervention

\- Single Dose on Day 1

Group XVIII: SSA: QIV1 Active Control 1 Intervention

\- Single dose on Day 1

Group XIX: SSB: QIV2 Active Control 1 Intervention

\- Single Dose on Day 1

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

cidrap.umn.edu

cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trial

Moderna announces promising efficacy results ... - CIDRAP

In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...

2.

cdc.gov

cdc.gov/flu-vaccines-work/php/effectiveness-studies/index.html

CDC Seasonal Flu Vaccine Effectiveness Studies

*2020-2021 flu vaccine effectiveness was not estimated due to low influenza virus circulation during the 2020-2021 flu season. A point estimate ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11970786/

An mRNA-based seasonal influenza vaccine in adults

The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains ...

4.

nature.com

nature.com/articles/s41541-025-01145-6

Comparing Moderna's mRNA-1083 and Pfizer's dual-target ...

Moderna's mRNA-1083 showed superior immune responses, while Pfizer's mRNA-1020/1030 performed well but was slightly less effective against ...

5.

trials.modernatx.com

trials.modernatx.com/study/?id=mRNA-1010-P302

A Clinical Trial of a Seasonal Influenza (Flu) Vaccine ...

Current flu vaccinations rarely exceed 60% overall effectiveness. Medical Condition. Seasonal Influenza (Flu). Medical Condition. Seasonal Influenza (Flu).

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9232269/

An analysis of the vaccine adverse event reporting system

Influenza vaccines are generally safe but can cause common side effects, such as headaches, soreness, redness, swelling, nausea, fever, and muscle aches (CDC, ...

7.

vaers.hhs.gov

vaers.hhs.gov/

Vaccine Adverse Event Reporting System (VAERS)

Have you had a reaction following a vaccination? Contact your healthcare provider. Report an Adverse Event using the VAERS online form or the downloadable PDF.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0264410X25001446

A phase 3 randomized safety and immunogenicity trial of ...

Solicited adverse reactions were more frequent with receipt of mRNA-1010; adverse reactions were lower in frequency and severity among adults ...

9.

thelancet.com

thelancet.com/journals/laninf/article/PIIS1473-3099(24)00493-6/abstract

Safety and immunogenicity of mRNA-based seasonal ...

We aimed to evaluate the safety and immunogenicity of three next-generation seasonal influenza mRNA vaccines with different compositions that encode for ...