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Virus Therapy

Modified RNA Vaccine for Flu

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
estrogen positive
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 days
Treatment 3 months
Follow Up3 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Study Summary

This trial will compare the efficacy of a new quadrivalent influenza modRNA vaccine to a licensed inactivated influenza vaccine in healthy adults 18 years and older.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 days
Treatment ~ 3 months
Follow Up ~3 months
This trial's timeline: 3 days for screening, 3 months for treatment, and 3 months 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, 18 through 64 years of age and ≥65 years of age separately and combined
Percentage of participants reporting local reactions, 18 through 64 years of age and ≥65 years of age separately
Percentage of participants reporting serious adverse events, 18 through 64 years of age and ≥65 years of age separately and combined
+3 more
Secondary outcome measures
Difference in percentage of participants achieving seroconversion for each strain between qIRV recipients and QIV recipients, 18 through 64 and ≥65 years of age separately
Geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers for each strain in qIRV recipients compared to QIV recipients, 18 through 64 and ≥65 years of age separately
HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and ≥65 years of age separately
+8 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
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Quadrivalent influenza modRNA vaccine, ≥65 years of ageExperimental Treatment1 Intervention
Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Group II: Quadrivalent influenza modRNA vaccine, 18 through 64 years of ageExperimental Treatment1 Intervention
Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Group III: Quadrivalent influenza vaccine, 18 through 64 years of ageActive Control1 Intervention
Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Group IV: Quadrivalent influenza vaccine, ≥65 years of ageActive Control1 Intervention
Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,513 Previous Clinical Trials
9,842,459 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,435 Previous Clinical Trials
7,071,415 Total Patients Enrolled

Media Library

Flu Research Study Groups: Quadrivalent influenza modRNA vaccine, 18 through 64 years of age, Quadrivalent influenza vaccine, 18 through 64 years of age, Quadrivalent influenza modRNA vaccine, ≥65 years of age, Quadrivalent influenza vaccine, ≥65 years of age

Frequently Asked Questions

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

Is the Quadrivalent influenza modRNA vaccine cleared by the FDA?

"There is evidence from past Phase 3 trials to support the efficacy of Quadrivalent influenza modRNA vaccine, so it received a score of 3."

Answered by AI

Are there any currently open vacancies for this trial?

"Active recruitment is underway for this clinical trial, which was first announced on September 12th, 2022. The most recent update was on October 24th, 2022. At present, the plan is to have 25,000 people enrolled at 100 different locations."

Answered by AI

How many participants are being sought for this experiment?

"In order to gain accurate results, this clinical trial requires 25000 participants that match the pre-specified inclusion criteria. patients are able to partake in this study from multiple locations, such as ActivMed Practices & Research, Inc. in Portsmouth, New Hampshire and Ascada Research in Fullerton, California."

Answered by AI

What is the purpose of this particular clinical trial?

"The primary objective of this clinical study, as stated by the sponsor, pharmaceutical company Pfizer, is to compare the rate of adverse events 4 weeks post-vaccination in adults aged 18-64 and those aged 65 and over. Additionally, this trial will compare the following secondary outcomes: the percentage of participants with a HAI titer of 1:40 or higher for each strain, the rate of seroconversion for each A strain between qIRV and QIV recipients, and the HAI geometric mean fold rise for each strain in adults aged 18-64 and those aged 65 and over."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Alabama
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Elligo Clinical Research Center
Ascension - St Vincent's
Sugar Lakes Family Practice
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
0

Why did patients apply to this trial?

Find the truth. To further research. Afraid of contracting flu. I support medical research.
PatientReceived 2+ prior treatments
Would like to make some money.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Are you in greater Houston? How many visits will be required in total? How long would each visit approximately take?
PatientReceived no prior treatments
How many visits will there be? Is this a paid study?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. WR-Global Medical Research, LLC: < 24 hours
  2. Sugar Lakes Family Practice: < 24 hours
  3. Diablo Clinical Research, Inc.: < 24 hours
Typically responds via
Phone Call
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
2022. "A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05540522.
All > Alabama > Kentucky
~9388 spots leftby Mar 2024
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