770 Participants NeededMy employer runs this trial

mRNA Vaccines for Flu

Recruiting at 14 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new mRNA flu vaccines to determine their safety and effectiveness in triggering the body's immune response against the flu virus. Participants will receive one dose of either an experimental mRNA flu vaccine or a standard flu vaccine for comparison. The trial aims to identify which vaccines work best and are safe for future use. Healthy adults who haven't had the flu or a flu shot in the last five months might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important vaccine development.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have taken antiviral medications for the flu in the last 5 months, you cannot participate.

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

Research has shown that the mRNA flu vaccines under study are generally safe. For Vaccine Candidate #1, studies found mild to moderate side effects, such as pain at the injection site, which resolved quickly. Serious side effects were rare. Vaccine Candidate #2 and Candidate #3 also demonstrated good safety, with no major concerns and mostly mild, temporary side effects.

Recent research on Vaccine Candidate #4 found no major safety issues, with some participants reporting mild reactions like soreness. Vaccine Candidate #5 and Candidate #6 also exhibited mild side effects, primarily short-lasting discomfort at the injection site. No serious problems emerged in these studies.

Overall, these mRNA vaccines have been well-tolerated in previous studies. When side effects occur, they are generally mild and resolve quickly.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these mRNA flu vaccine candidates because they offer a cutting-edge approach different from traditional flu vaccines, which typically use inactivated or weakened viruses. Unlike those standard vaccines, mRNA vaccines work by instructing cells to produce a protein that triggers an immune response, potentially leading to a more robust and targeted protection against the flu. The rapid adaptability of mRNA technology also means these vaccines can be updated quickly to match circulating flu strains, offering a significant advantage in responding to seasonal changes. Additionally, because these vaccines use a synthetic process rather than growing viruses in eggs, they can be produced more rapidly and with fewer allergic reactions.

What evidence suggests that this trial's mRNA flu vaccines could be effective?

This trial will evaluate multiple mRNA influenza vaccine candidates. Research has shown that mRNA-based flu vaccines hold promise. Studies have found that these vaccines, such as mRNA-1010, can be more effective than traditional egg-based flu vaccines. In some trials, mRNA flu vaccines outperformed regular flu shots by about 26.6% to 35%. These vaccines use mRNA to train the body to combat the flu virus, resulting in strong immune responses. Early results also suggest they are generally safe, with mostly mild and short-lasting side effects. Overall, evidence supports that mRNA flu vaccines could offer better protection against the flu.12678

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 or older who are medically stable. Participants should not have any major health issues and must be considered eligible by the study doctor.

Inclusion Criteria

• Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.

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 an experimental mRNA influenza vaccine or a licensed influenza vaccine via intramuscular injection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, with blood samples taken at each visit

6 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Vaccine Candidate #1
  • Vaccine Candidate #2
  • Vaccine Candidate #3
  • Vaccine Candidate #4
  • Vaccine Candidate #5
  • Vaccine Candidate #6

Trial Overview

The study is testing several experimental mRNA flu vaccines against approved flu vaccines. Each participant will get one dose in their arm and be monitored over about 6 months, with at least three clinic visits for blood tests and a nasal swab.

How Is the Trial Designed?

7

Treatment groups

Experimental Treatment

Active Control

Group I: FExperimental Treatment1 Intervention
Group II: EExperimental Treatment1 Intervention
Group III: DExperimental Treatment1 Intervention
Group IV: CExperimental Treatment1 Intervention
Group V: BExperimental Treatment1 Intervention
Group VI: AExperimental Treatment1 Intervention
Group VII: GActive Control1 Intervention

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Efficacy, Immunogenicity, and Safety of Modified mRNA ...

However, overall vaccine effectiveness against influenza is suboptimal, with a range of 10 to 60% from 2004 through 2023. The match between ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41701031/

Results from a phase 1, randomized, dose-escalation study

We found that side effects after mRNA Flu vaccination were mostly mild or moderate and were short-lived, even at the highest vaccine doses. Only a few serious ...

Moderna announces promising efficacy results from mRNA ...

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 ...

An mRNA influenza vaccine induces immunity comparable ...

We have developed an mRNA-based seasonal influenza hemagglutinin (HA) vaccine, mRNA-1010, that was demonstrated to be safe and immunogenic in ...

Experimental mRNA flu vaccine shows superior efficacy ...

mRNA vaccines are more effective than egg-based vaccines and can be made more quickly, increasing the likelihood that they match circulating flu ...

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

No safety concerns were identified. Conclusions. These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine.

Immunogenicity and safety of mRNA-based seasonal ...

We report first-in-human findings from a phase 1/2 study of mRNA-based seasonal influenza vaccines targeting both HA and NA (mRNA-1020 and mRNA-1030) in ...

Moderna's mRNA Flu Vaccines Show Promising Efficacy and ...

Both vaccine candidates were well-tolerated with no safety concerns identified, showing only mild side effects like injection site pain and ...