Cytomegalovirus Vaccine

  • STATUS
    Recruiting
  • sponsor
    ModernaTX, Inc.
Updated on 19 January 2022

Summary

The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants.

Description

  • Condition: Cytomegalovirus Vaccine
  • Clinical Trial Identifier: NCT05085366
  • Sponsor: ModernaTX, Inc.

Details
Condition Vaccines
Clinical Study IdentifierTX291016
SponsorModernaTX, Inc.
Last Modified on19 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Females age 16 to 40 years
Has a body mass index of 15-35 kilograms (kg)/square meter (m^2), inclusive
Female participants: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1). If the participant is sexually active, has practiced adequate contraception for at least 28 days prior to the first injection (Day 1) and agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257)

Exclusion Criteria

Female participant is of non-childbearing potential
History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures
Previous receipt of an investigational CMV vaccine
Clear my responses

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.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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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