157 Participants Needed

modRNA Vaccine for Flu

Recruiting at 3 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer

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.12345

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.12367

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.13589

Research Team

PC

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
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: pdmFlu vaccine 8Experimental Treatment1 Intervention
Group II: pdmFlu vaccine 7Experimental Treatment1 Intervention
Group III: pdmFlu vaccine 6Experimental Treatment1 Intervention
Group IV: pdmFlu vaccine 5Experimental Treatment1 Intervention
Group V: pdmFlu vaccine 4Experimental Treatment1 Intervention
Group VI: pdmFlu vaccine 3Experimental Treatment1 Intervention
Group VII: pdmFlu vaccine 2Experimental Treatment1 Intervention
Group VIII: pdmFlu vaccine 1Experimental Treatment1 Intervention
Group IX: Licensed influenza vaccineActive Control1 Intervention
Group X: PlaceboPlacebo Group1 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

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.
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.
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.
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]

References

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]
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]
Immunogenicity and safety of inactivated quadrivalent influenza vaccine in adults: A systematic review and meta-analysis of randomised controlled trials. [2018]
Cost-Effectiveness of Quadrivalent versus Trivalent Influenza Vaccine in the United States. [2017]
Vaccine for prevention of mild and moderate-to-severe influenza in children. [2014]
From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain. [2020]
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system. [2022]
Alternative Strategy for a Quadrivalent Live Attenuated Influenza Virus Vaccine. [2020]
Development of a pentavalent broadly protective nucleoside-modified mRNA vaccine against influenza B viruses. [2023]
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