A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

  • STATUS
    Recruiting
  • days left to enroll
    52
  • participants needed
    615
  • sponsor
    Pfizer
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Updated on 28 October 2022
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strain
vaccination
influenza vaccination
trivalent influenza vaccine
quadrivalent inactivated influenza vaccine
Accepts healthy volunteers

Summary

This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB)

Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:

  • 1 of 4 dose levels of mIRV (either A or B Strain),
  • 1 of 4 dose levels of bIRV (containing both A and B strains),
  • qIRV (at 1 dose level), or
  • A licensed quadrivalent influenza vaccine (QIV).

At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:

  • mIRV encoding A strain at dose level 4, or
  • mIRV encoding B strain at dose level 4.

Substudy B

This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:

2-Visit Schedules

  • 2 doses of qIRV (at a dose level 1), administered 21 days apart.
  • 2 doses of licensed QIV, administered 21 days apart (as a control group)
  • A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.

1-Visit Schedules

  • A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
  • A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
  • A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
  • A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
  • 1 dose of licensed QIV (as a control group).

Substudy B

In participants 18 to 64 years of age:

-A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.

Details
Condition Influenza, Human
Treatment QIV, mIRV, bIRV, qIRV, bIRV AB, bIRV AA, bIRV BB
Clinical Study IdentifierNCT05052697
SponsorPfizer
Last Modified on28 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female participants 65 to 85 years of age or .Male or female participants 18 to 64 years of age
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study
For participants 65 to 85 years of age at the time of enrollment, receipt of licensed influenza vaccination for the 2021-2022 northern hemisphere season >4 months (120 days) before study intervention administration
Capable of giving signed informed consent

Exclusion Criteria

Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
Women who are pregnant or breastfeeding
Allergy to egg proteins (egg or egg products) or chicken proteins
Participant who has had significant exposure to laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 201
Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study
Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 201 that has not been confirmed as negative
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study
Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 28 days of Visit 201
Any participant who has received licensed influenza vaccination for the 2022-2023 northern hemisphere influenza season
Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation
Participation in strenuous or endurance exercise through Visit 205
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
Any abnormal screening troponin I laboratory value
Prior history of heart disease
Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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