ClinicalTrials.Veeva

Menu
The trial is taking place at:
A

Alliance for Multispecialty Research, LLC. | New Orleans, LA

Veeva-enabled site

A Study About Modified RNA Vaccines Against Influenza in Healthy Adults

Pfizer logo

Pfizer

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Influenza, Human

Treatments

Biological: Influenza ModRNA Vaccine
Biological: Quadrivalent Influenza Vaccine (QIV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06436703
C4781013

Details and patient eligibility

About

The purpose of this study is to learn if modified RNA (modRNA) vaccines for the prevention of influenza are:

  • safe; and
  • how these vaccines produce an immune response in generally healthy adults. Immune response is the way the body protects itself against things it sees as harmful or foreign.

RNA (also called ribonucleic acid) is one of two types of nucleic acid made by cells. RNA contains information that has been copied from DNA (the other type of nucleic acid). Cells make several different forms of RNA, and each form has a specific job in the cell. Many forms of RNA have functions related to making proteins. RNA is also the genetic material of some viruses instead of DNA. RNA can be made in the laboratory and used in research studies. Also called ribonucleic acid.

Influenza is term used for flu illness. It is an infection caused by a virus that affects your mouth, nose, and throat.

The study is seeking for participants who:

  • are at least 18 years of age
  • have not received an influenza vaccine within the last 6 months
  • are generally healthy

This study will be divided into three sub-studies: Substudy A (SSA), Substudy B (SSB), and Substudy C (SSC).

All participants, regardless of sub-study, will receive 1 dose of either of the following vaccines as an injection into their arm:

  • 1 of the modRNA influenza vaccines that is being studied; or
  • an approved influenza vaccine approved for use in their respective age group.

Participants will be involved in this study for about 6 months. During this time, participants will have at least 3 clinic visits.

Enrollment

1,202 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

Applies to all 3 substudies:

  • participants ≥18 years of age.
  • generally healthy participants.

Substudy C ONLY:

  • receipt of licensed influenza vaccination for the 2023-2024 flu season at least 6 months ago.

Key Exclusion Criteria

All 3 substudies:

  • diagnosis of influenza (by clinical testing) in the last 6 months.
  • immunocompromised individuals with known or suspected immunodeficiency
  • receipt of any investigational or licensed influenza vaccines within 6 months.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,202 participants in 19 patient groups

SSA: Influenza ModRNA Vaccine 2A
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 3A
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 4A
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSA: Influenza ModRNA Vaccine 5A
Experimental group
Description:
- Single dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSA: QIV1
Active Comparator group
Description:
- Single dose on Day 1
Treatment:
Biological: Quadrivalent Influenza Vaccine (QIV)
SSB: Influenza ModRNA Vaccine 3B
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSB: Influenza ModRNA Vaccine 4B
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSB: Influenza ModRNA Vaccine 5B
Experimental group
Description:
- Single dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSB: QIV2
Active Comparator group
Description:
- Single Dose on Day 1
Treatment:
Biological: Quadrivalent Influenza Vaccine (QIV)
SSB: QIV3
Active Comparator group
Description:
- Single Dose on Day 1
Treatment:
Biological: Quadrivalent Influenza Vaccine (QIV)
SSC: Influenza ModRNA Vaccine 3C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 4C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 5C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 6C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 7C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 8C
Experimental group
Description:
- Single Dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: Influenza ModRNA Vaccine 9C
Experimental group
Description:
- Single dose on Day 1
Treatment:
Biological: Influenza ModRNA Vaccine
SSC: QIV2
Active Comparator group
Description:
- Single Dose on Day 1
Treatment:
Biological: Quadrivalent Influenza Vaccine (QIV)
SSC: QIV3
Active Comparator group
Description:
- Single Dose on Day 1
Treatment:
Biological: Quadrivalent Influenza Vaccine (QIV)

Trial contacts and locations

31

Loading...

Central trial contact

Pfizer CT.gov Call Center

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems