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Cancer Vaccine

PF-07985819 pdmFlu vaccine dose A for Flu

Q: Are there any vacancies available for patients to participate in this trial?

According to the information available on clinicaltrials.gov, this particular clinical trial is no longer actively seeking participants. The study was initially listed on 12/13/2023 and last updated on 12/12/2023. It is important to note that while this specific trial may not be recruiting anymore, there are currently 146 other trials actively looking for eligible participants at this time.

Q: Are there any age restrictions for potential participants in this clinical trial, specifically with regards to individuals over the age of 35?

To be eligible for enrollment in this clinical trial, patients must fall within the age range of 18 to 49 years old. Please note that there are a total of 42 trials available specifically for patients under the age of 18 and an additional 88 trials targeting patients over the age of 65.

Q: What is the level of safety associated with administering dose B of the PF-07985819 pdmFlu vaccine to patients?

The safety rating for the PF-07985819 pdmFlu <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a> dose B is designated as 1, indicating that this Phase 1 trial has limited data supporting its safety and efficacy.

Q: Is it possible for me to participate in this ongoing medical study?

To be eligible for participation in this research, potential candidates must have received the necessary vaccinations and fall within the age range of 18 to 49. Overall, a maximum of 60 individuals will be accepted into this study.

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2

Awards & highlights

Study Summary

This trial is testing a new vaccine called Pandemic Influenza modRNA (pdmFlu) Vaccine to see if it can prevent the flu. They are looking for participants between the ages

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include pain at the injection site, fever, fatigue, headache, muscle pains similar to those experienced with other vaccines but specific risks of pdmFlu Vaccine will be studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1-, 3-weeks after vaccination 1, and 1-week, 4-weeks and 6-months after vaccination 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants reporting adverse events

Percentage of participants reporting local reactions

Percentage of participants reporting medically attended adverse events

+7 more

Secondary outcome measures

Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint

Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers

Proportion of participants achieving HAI seroconversion

+1 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: PF-07985819 pdmFlu vaccine dose BExperimental Treatment1 Intervention

Group II: PF-07985819 pdmFlu vaccine dose AExperimental Treatment1 Intervention

Group III: PF-07985819 pdmFlu Vaccine dose CExperimental Treatment1 Intervention

Group IV: Quadrivalent influenza vaccine (QIV)Active Control1 Intervention

Group V: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,946 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,161 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"According to the information available on clinicaltrials.gov, this particular clinical trial is no longer actively seeking participants. The study was initially listed on 12/13/2023 and last updated on 12/12/2023. It is important to note that while this specific trial may not be recruiting anymore, there are currently 146 other trials actively looking for eligible participants at this time."

Answered by AI

Are there any age restrictions for potential participants in this clinical trial, specifically with regards to individuals over the age of 35?

"To be eligible for enrollment in this clinical trial, patients must fall within the age range of 18 to 49 years old. Please note that there are a total of 42 trials available specifically for patients under the age of 18 and an additional 88 trials targeting patients over the age of 65."

Answered by AI

What is the level of safety associated with administering dose B of the PF-07985819 pdmFlu vaccine to patients?

"The safety rating for the PF-07985819 pdmFlu vaccine dose B is designated as 1, indicating that this Phase 1 trial has limited data supporting its safety and efficacy."

Answered by AI

Is it possible for me to participate in this ongoing medical study?

"To be eligible for participation in this research, potential candidates must have received the necessary vaccinations and fall within the age range of 18 to 49. Overall, a maximum of 60 individuals will be accepted into this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza

2023. "A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179446.

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