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A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Females 16-40 Years of Age (mRNA-1647-P301)

Recruiting

This is a Phase 3, randomized, observer-blinded, placebo-controlled study in healthy participants 16 to 40 years of age. The primary efficacy objective is to demonstrate vaccine effect of mRNA-1647 against primary cytomegalovirus (CMV) infection in female participants who are CMV-seronegative at enrollment.

I'm interested

Female
Not specified
This study is also accepting healthy volunteers
Key
Inclusion Criteria:

• Participants aged ≥20 years, has or anticipates having direct exposure (in the home, socially, or occupationally) to at least 1 child ≤5 years of age. Direct exposure is defined as either participant is the parent, or participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
• CMV-seronegative Cohort is CMV-seronegative based on CMV testing at Screening.
• CMV-seropositive Cohort is CMV-seropositive based on CMV testing at Screening.
• Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/legally acceptable representative (LAR)(s), as applicable, understand and are willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30 month study period.
• 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). Key
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.
• Received or plans to receive any nonstudy vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
• Any Coronavirus disease 2019 (COVID-19) vaccination series must have been completed a minimum 28 days prior to receiving any dose of the study injection.
• COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
• Influenza vaccines may be administered > 14 days prior to or after any study injection.
• Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥5 milligrams (mg)/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
• Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) <2 weeks prior to the day of first injection or plans to do so during the course of the study.
• Previous receipt of an investigational CMV vaccine.
• Receipt of systemic immunoglobulins or blood products <3 months prior to the day of first injection.
• Participated in an interventional clinical study <28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
• Participant has donated ≥450 milliliters (mL) of blood products <28 days prior to Screening.
• Participant is a member of study team or is an immediate family member or household member of study personnel.

Biological: mRNA-1647, Biological: Placebo

Cytomegalovirus Infection

mRNA-1647, Moderna, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA

Ellen Bruno - bruno033@umn.edu
Mark Schleiss
Phase 3
STUDY00013943
NCT05085366
See this study on ClinicalTrials.gov

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