modRNA Vaccine for Flu

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

157 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine. This study is seeking for participants who are: * between the ages of 18 to 49 years old or 65 to 84 years old. * willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures. * healthy as confirmed by medical history, physical examinations, and the study doctor. * capable of signing informed consent. Participants will receive either: * the pdmFlu vaccine, * a licensed influenza vaccine * a placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.

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.

What data supports the effectiveness of the modRNA Vaccine for Flu treatment?

Research shows that quadrivalent influenza vaccines (QIVs), which are part of the treatment, are effective because they include two A strains and two B lineages, reducing the chance of a mismatch with circulating flu strains. This makes them more effective than trivalent vaccines, which only cover one B lineage. ^{1 2 3 4 5}

Is the modRNA Vaccine for Flu safe for humans?

The quadrivalent influenza vaccines (QIVs) have been studied for safety in various age groups, showing a low rate of adverse events (side effects), with most not requiring medical attention. In a study with 2013 participants, only 9.09% reported any side effects, and none required hospitalization, indicating a generally safe profile. ^{1 2 3 6 7}

How is the modRNA Vaccine for Flu different from other flu treatments?

The modRNA Vaccine for Flu is unique because it uses messenger RNA (mRNA) technology, which allows for rapid development and the potential to create a universal flu vaccine that provides long-lasting protection against multiple strains of the virus. This is different from traditional flu vaccines that typically use inactivated or live attenuated viruses. ^{1 3 5 8 9}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 (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]

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]

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]

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]

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 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]

References

1. Netherlands 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. [2021]

2. United States 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. [2022]

3. Netherlands 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Quadrivalent versus Trivalent Influenza Vaccine in the United States. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Vaccine for prevention of mild and moderate-to-severe influenza in children. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain. [2020]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Alternative Strategy for a Quadrivalent Live Attenuated Influenza Virus Vaccine. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Development of a pentavalent broadly protective nucleoside-modified mRNA vaccine against influenza B viruses. [2023]