Influenza

  • STATUS
    Recruiting
  • sponsor
    Pfizer
Updated on 21 April 2022
strain
vaccination
trivalent influenza vaccine
quadrivalent inactivated influenza vaccine

Summary

This is a Phase 1 randomized study 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, orA licensed quadrivalent influenza vaccine (QIV).

Description

  • Condition: Influenza
  • Clinical Trial Identifier: NCT05052697
  • Sponsor: Pfizer

Details
Condition Influenza
Clinical Study IdentifierTX290587
SponsorPfizer
Last Modified on21 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants 65 to 85 years of age
Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children

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
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 1
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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