Quadrivalent influenza modRNA vaccine for Influenza, Human

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Kaiser Permanente, Los Angeles, CA
Influenza, Human
Quadrivalent influenza modRNA vaccine - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

7 Primary · 15 Secondary · Reporting Duration: Before vaccination and at 4 weeks and 6 months after vaccination

4 weeks after vaccination
Difference in percentage achieving seroconversion for each A strain between qIRV recipients and QIV recipients, 18 through 64 and ≥65 years of age separately
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
GMR of HAI titers for each A strain in qIRV recipients compared to QIV recipients, 18 through 64 years of age 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
Month 6
HAI geometric mean titers (GMTs) for each strain, 18 through 64 years of age and ≥65 years of age separately
The proportion of participants achieving HAI seroconversion for all strains, 18 through 64 years of age and ≥65 years of age separately
The proportion of participants achieving HAI seroconversion for each strain, 18 through 64 years of age and ≥65 years of age separately
Day 14
The proportion of participants reporting LCI associated with ILI, as defined by applying a modified CDC definition, in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined
The proportion of participants reporting LCI cases associated with ILI, as defined by applying the WHO definition, in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined
The proportion of participants reporting LCI cases with associated per-protocol ILI caused by all matched strains or each matched strain in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined
The proportion of participants reporting LCI cases with associated per-protocol ILI in each vaccine group, 18 through 64 years of age
The proportion of participants reporting LCI cases with associated per-protocol ILI in each vaccine group, ≥65 years of age
The proportion of participants reporting cases of influenza, as confirmed by local RT-PCR or culture, with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined
The proportion of participants reporting culture-confirmed influenza (CCI) cases with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined
The proportion of participants reporting laboratory-confirmed influenza (LCI) cases with associated per-protocol influenza-like illness (ILI) in each vaccine group, 18 through 64 years of age and ≥65 years of age combined
Month 6
HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and ≥65 years of age separately
The proportion of participants with HAI titers ≥1:40 for all strains, 18 through 64 years of age and ≥65 years of age separately
The proportion of participants with HAI titers ≥1:40 for each strain, 18 through 64 years of age and ≥65 years of age separately
Day 7
Percentage of participants reporting local reactions, 18 through 64 years of age and ≥65 years of age separately and combined
Percentage of participants reporting systemic events, 18 through 64 years of age and ≥65 years of age separately and combined
Week 4
Percentage of participants reporting adverse events, 18 through 64 years of age and ≥65 years of age separately and combined
Month 6
Percentage of participants reporting serious adverse events, 18 through 64 years of age and ≥65 years of age separately and combined

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Quadrivalent influenza vaccine, ≥65 years of age
1 of 4
Quadrivalent influenza vaccine, 18 through 64 years of age
1 of 4
Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
1 of 4
Quadrivalent influenza modRNA vaccine, ≥65 years of age
1 of 4
Active Control
Experimental Treatment

25000 Total Participants · 4 Treatment Groups

Primary Treatment: Quadrivalent influenza modRNA vaccine · No Placebo Group · Phase 3

Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
Biological
Experimental Group · 1 Intervention: Quadrivalent influenza modRNA vaccine · Intervention Types: Biological
Quadrivalent influenza modRNA vaccine, ≥65 years of age
Biological
Experimental Group · 1 Intervention: Quadrivalent influenza modRNA vaccine · Intervention Types: Biological
Quadrivalent influenza vaccine, ≥65 years of age
Biological
ActiveComparator Group · 1 Intervention: Quadrivalent influenza vaccine · Intervention Types: Biological
Quadrivalent influenza vaccine, 18 through 64 years of age
Biological
ActiveComparator Group · 1 Intervention: Quadrivalent influenza vaccine · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: before vaccination and at 4 weeks and 6 months after vaccination
Closest Location: Kaiser Permanente · Los Angeles, CA
Photo of Los Angeles 1Photo of Los Angeles 2Photo of Los Angeles 3
2012First Recorded Clinical Trial
2 TrialsResearching Influenza, Human
189 CompletedClinical Trials

Who is running the clinical trial?

PfizerLead Sponsor
4,229 Previous Clinical Trials
6,641,581 Total Patients Enrolled
6 Trials studying Influenza, Human
33,416 Patients Enrolled for Influenza, Human
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,226 Previous Clinical Trials
4,358,430 Total Patients Enrolled
3 Trials studying Influenza, Human
2,199 Patients Enrolled for Influenza, Human

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are capable of giving informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.