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Cancer Vaccine

Modified RNA Vaccines for Flu

Phase 1 & 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be ≥18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 through at least day 7 after vaccination
Awards & highlights

Summary

"This trial is testing a new type of flu vaccine made from modified RNA to see if it is safe and how it triggers an immune response in healthy adults. They are looking for participants who have not received

Who is the study for?
This trial is for generally healthy adults over 18 who haven't had a flu shot in the last 6 months. It's to see if new modRNA vaccines are safe and how they affect the body's defense against flu.
What is being tested?
The study tests modified RNA (modRNA) vaccines against influenza, comparing them with an approved Quadrivalent Influenza Vaccine (QIV). Participants will be randomly assigned to receive one dose of either vaccine.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, fever, fatigue, headache, muscle pains, and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 through at least day 7 after vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 through at least day 7 after vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SSA - Percentage of Participants Reporting Adverse Events After Vaccination
SSA - Percentage of Participants Reporting Local Reactions After Vaccination
SSA - Percentage of Participants Reporting Medically Attended AEs (MAEs)
+15 more
Secondary outcome measures
SSA - HAI Geometric Mean Titers (GMTs) for each strain
SSA - HAI geometric mean fold rise (GMFR) for each strain
SSA - The proportion of participants achieving HAI seroconversion for each strain
+5 more

Side effects data

From 2023 Phase 4 trial • 267 Patients • NCT05007041
8%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
1%
Acute pulmonary embolism and acute deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine

Trial Design

19Treatment groups
Experimental Treatment
Active Control
Group I: SSC: Influenza ModRNA Vaccine 9CExperimental Treatment1 Intervention
- Single dose on Day 1
Group II: SSC: Influenza ModRNA Vaccine 8CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group III: SSC: Influenza ModRNA Vaccine 7CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group IV: SSC: Influenza ModRNA Vaccine 6CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group V: SSC: Influenza ModRNA Vaccine 5CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group VI: SSC: Influenza ModRNA Vaccine 4CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group VII: SSC: Influenza ModRNA Vaccine 3CExperimental Treatment1 Intervention
- Single Dose on Day 1
Group VIII: SSB: Influenza ModRNA Vaccine 5BExperimental Treatment1 Intervention
- Single dose on Day 1
Group IX: SSB: Influenza ModRNA Vaccine 4BExperimental Treatment1 Intervention
- Single Dose on Day 1
Group X: SSB: Influenza ModRNA Vaccine 3BExperimental Treatment1 Intervention
- Single Dose on Day 1
Group XI: SSA: Influenza ModRNA Vaccine 5AExperimental Treatment1 Intervention
- Single dose on Day 1
Group XII: SSA: Influenza ModRNA Vaccine 4AExperimental Treatment1 Intervention
- Single Dose on Day 1
Group XIII: SSA: Influenza ModRNA Vaccine 3AExperimental Treatment1 Intervention
- Single Dose on Day 1
Group XIV: SSA: Influenza ModRNA Vaccine 2AExperimental Treatment1 Intervention
- Single Dose on Day 1
Group XV: SSA: QIV1Active Control1 Intervention
- Single dose on Day 1
Group XVI: SSB: QIV3Active Control1 Intervention
- Single Dose on Day 1
Group XVII: SSB: QIV2Active Control1 Intervention
- Single Dose on Day 1
Group XVIII: SSC: QIV2Active Control1 Intervention
- Single Dose on Day 1
Group XIX: SSC: QIV3Active Control1 Intervention
- Single Dose on Day 1

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,595 Previous Clinical Trials
12,867,600 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,044,209 Total Patients Enrolled
~585 spots leftby Feb 2025
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