modRNA Vaccine for Flu

No longer recruiting at 3 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Seasonal influenza vaccine, others

Compensation: Varies

Number of Visits: 1

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 a new modRNA vaccine designed to prevent the flu. Participants will receive either the study vaccine, a licensed flu vaccine (Quadrivalent influenza vaccine, QIV), or a placebo (inactive shot). The goal is to determine how well the study vaccine works compared to the other options. The trial seeks healthy adults without flu vaccine restrictions. Participants will assist researchers in assessing whether this new vaccine can be a safe option for flu prevention. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor to understand any specific requirements.

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

Research has shown that the pdmFlu vaccine is generally safe and well-tolerated. For example, a study with a similar modRNA vaccine reported mild side effects, such as pain at the injection site in about 65% of participants and fatigue in around 59%. Ongoing safety reviews have not identified any major safety issues.

Another study of a related mRNA-based flu vaccine found that side effects were mostly mild and rarely required a doctor's visit. The overall rate of unwanted effects was low, at just 9%, and most were not serious.

These findings suggest that the pdmFlu vaccine is likely safe for people, based on previous studies of similar vaccines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the modRNA flu vaccine, PF-07985819, because it represents a new frontier in flu prevention. Unlike traditional flu vaccines, which often use inactivated or weakened viruses, this vaccine uses modRNA technology to instruct cells to produce a protein that triggers an immune response. This innovative approach could lead to more rapid and adaptable vaccine production, potentially enhancing effectiveness against emerging flu strains. Additionally, the modRNA platform has shown promise in other vaccines, such as those for COVID-19, suggesting it could offer a robust and flexible solution for seasonal influenza.

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

Research has shown that mRNA flu vaccines could offer strong protection against the flu. Moderna's mRNA flu vaccine proved to be 26.6% more effective than standard flu vaccines, suggesting that mRNA technology might enhance flu prevention. Another study indicated that traditional flu vaccines are often more than 50% effective in healthy individuals. This trial will test the pdmFlu vaccine, which uses modRNA technology to target multiple flu strains. While data on the pdmFlu vaccine is still being collected, early results from similar mRNA vaccines appear promising. ^{1 4 6 7 8}

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 healthy adults aged 18 to 49 who can commit to the study's schedule and procedures. They must not have received any flu vaccine in the past 6 months and should be able to give informed consent.

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.

Exclusion Criteria

Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single shot of either the pdmFlu vaccine, a licensed influenza vaccine, or a placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after receiving the vaccine

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• PF-07985819 pdmFlu Vaccine
• Placebo
• Quadrivalent influenza vaccine (QIV)

Trial Overview

The trial is testing a new mRNA vaccine for pandemic influenza, comparing it with a licensed quadrivalent influenza vaccine (QIV) and a placebo. Participants will get shots on day 1 and day 21 without knowing which one they receive.

How Is the Trial Designed?

Group I: pdmFlu vaccine 8 Experimental Treatment 1 Intervention

Group II: pdmFlu vaccine 7 Experimental Treatment 1 Intervention

Group III: pdmFlu vaccine 6 Experimental Treatment 1 Intervention

Group IV: pdmFlu vaccine 5 Experimental Treatment 1 Intervention

Group V: pdmFlu vaccine 4 Experimental Treatment 1 Intervention

Group VI: pdmFlu vaccine 3 Experimental Treatment 1 Intervention

Group VII: pdmFlu vaccine 2 Experimental Treatment 1 Intervention

Group VIII: pdmFlu vaccine 1 Experimental Treatment 1 Intervention

Group IX: Licensed influenza vaccine Active Control 1 Intervention

Group X: Placebo Placebo Group 1 Intervention

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

Published Research Related to This Trial

A new active surveillance system called SICOVA was developed in Mexico to monitor adverse events (AEs) following quadrivalent influenza vaccination, involving 2013 participants over three influenza seasons.

The overall adverse event rate was 9.09%, with most AEs being mild and not requiring medical visits, confirming the established safety profile of the Fluzone® Quadrivalent vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system. Betancourt-Cravioto, M., Cervantes-Powell, P., Tapia-Conyer, R., et al.[2022]

The quadrivalent influenza vaccine (QIV) demonstrated similar efficacy to the trivalent influenza vaccine (TIV) for the three common strains, but showed superior immunogenicity for the additional B lineages not included in TIV, with significant increases in seroprotection and seroconversion rates.

Both QIV and TIV had comparable safety profiles, with no serious adverse events reported; however, QIV was associated with a slightly higher incidence of injection-site pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. Moa, AM., Chughtai, AA., Muscatello, DJ., et al.[2018]

Switching from trivalent influenza vaccines (TIV) to quadrivalent influenza vaccines (QIV) could reduce influenza B cases by 27.2% over the next 20 years, preventing approximately 137,600 hospitalizations and 16,100 deaths.

QIV is projected to be a cost-effective option compared to TIV, with an incremental cost-effectiveness ratio of $27,411 per quality-adjusted life-year (QALY) gained, making it a beneficial addition to the US immunization program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Quadrivalent versus Trivalent Influenza Vaccine in the United States. de Boer, PT., Crépey, P., Pitman, RJ., et al.[2017]

Switching from the trivalent influenza vaccine (TIV) to the quadrivalent influenza vaccine (QIV) in Spain could prevent approximately 138,707 cases of influenza B each season, leading to significant reductions in outpatient visits, hospitalizations, and deaths.

The economic analysis suggests that this switch could save over €18 million annually in healthcare costs and productivity losses, making QIV a cost-effective intervention for the Spanish National Health Service, particularly benefiting those aged 65 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain. Crépey, P., Redondo, E., Díez-Domingo, J., et al.[2020]

The study compared the immunogenicity and safety of two quadrivalent influenza vaccines in 480 healthy adults and elderly participants, finding that both vaccines elicited comparable immune responses with high seroprotection rates (>90% for A-strains).

Both vaccines had a favorable safety profile, with adverse events reported in less than 1% of participants, indicating that Influvac® Tetra is a safe and effective option similar to the reference vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult and elderly participants in India - A phase III, active-controlled, randomized clinical study. Basu, I., Agarwal, M., Shah, V., et al.[2022]

The quadrivalent influenza vaccine AdimFlu-S showed strong immunogenicity in a study of 174 healthy children aged 3 to 17, achieving high seroprotection rates above 96.4% for all vaccine strains.

The vaccine was well tolerated with no serious adverse events reported over a 6-month follow-up period, indicating it is a safe option for improving protection against different influenza B lineages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. Chang, CY., Cho, CY., Lai, CC., et al.[2021]

The study developed a universal influenza B virus vaccine using a lipid nanoparticle-encapsulated mRNA platform, which showed the ability to elicit strong immune responses against both ancestral and recent strains of the virus.

A pentavalent vaccine containing multiple antigens was effective in protecting mice from illness at a very low dose of just 50 ng per antigen after a single vaccination, highlighting its potential as a universal vaccine candidate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a pentavalent broadly protective nucleoside-modified mRNA vaccine against influenza B viruses. Pardi, N., Carreño, JM., O'Dell, G., et al.[2023]

A new quadrivalent live attenuated influenza virus (QIV) vaccine formulation has been developed that effectively protects against lethal challenges from both influenza A and B viruses, as demonstrated in naive DBA/2J mice.

This QIV elicited strong immune responses, with hemagglutination inhibition (HI) titers of ≥40 after two doses, indicating its potential as a safer and more effective alternative to existing influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternative Strategy for a Quadrivalent Live Attenuated Influenza Virus Vaccine. Wan, Z., Cardenas Garcia, S., Liu, J., et al.[2020]

The quadrivalent influenza vaccine (QIV) demonstrated a significant efficacy of 59.3% in preventing rt-PCR-confirmed influenza in children aged 3 to 8 years, compared to a control group receiving the hepatitis A vaccine, based on a study involving 2584 children.

The QIV also showed a 74.2% efficacy against moderate-to-severe influenza and was associated with lower risks of high fever and lower respiratory tract illness, indicating both safety and effectiveness in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccine for prevention of mild and moderate-to-severe influenza in children. Jain, VK., Rivera, L., Zaman, K., et al.[2014]

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05540522

NCT05540522 | A Study to Evaluate a Modified RNA ...

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12103547/

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

Influenza vaccinations have an effectiveness rate of over 50% in healthy individuals, as seen in individuals over 50 years old. This may ...

4.

withpower.com

withpower.com/trial/phase-1-vaccines-11-2023-a5e90

modRNA Vaccine for Flu - Clinical Trials

Switching from trivalent influenza vaccines (TIV) to quadrivalent influenza vaccines (QIV) could reduce influenza B cases by 27.2% over the next 20 years, ...

5.

fiercebiotech.com

fiercebiotech.com/biotech/modernas-mrna-flu-vaccine-beats-approved-competitor-latest-phase-3-win

Moderna's mRNA flu vaccine beats approved competitor in ...

Moderna said its own vaccine, dubbed mRNA-1010, had achieved a relative vaccine efficacy (rVE) of 26.6% over a “licensed standard-dose seasonal influenza ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9958848/

Adverse Reactions after BNT162b2 Messenger RNA ...

The most common local and systemic adverse reactions were injection site pain (65.0%) and fatigue (58.6%), respectively. Injection-site pain was ...

7.

pfizer.com

pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-mrna-based-combination

Pfizer and BioNTech Provide Update on mRNA-based ...

No safety signals with the combination vaccine have been identified in an ongoing safety data review. Participants who received a licensed ...

8.

pmc.ncbi.nlm.nih.gov

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

An mRNA-based seasonal influenza vaccine in adults

mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials.