JPRN-jRCT2031220459
Recruiting
Phase 3
A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age
Tsutsui Toshio0 sites400 target enrollmentStarted: November 25, 2022Last updated:
ConditionsPrevention of primary CMV infection
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Tsutsui Toshio
- Enrollment
- 400
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 16age old to <= 40age old (—)
- Sex
- Female
Inclusion Criteria
- •Participants aged 20 years or over, has or anticipates having direct exposure within 7 months after the planned first dose (in the home, socially, or occupationally) to at least 1 child 5 years or under 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.
- •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
- •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 less than 28 days prior to and after 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 more than 14 days prior to or after any study injection.
- •Received systemic immunosuppressants or immune\-modifying drugs for more than 14 days in total within 6 months prior to the day of first injection (Day 1\) (for corticosteroids, 5 milligrams (mg)/day or over of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed. Stable immunomodulator regimens used for managing environmental allergies are allowed.
- •Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) less than 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 less than 3 months prior to the day of first injection.
- •Participated in an interventional clinical study less than 28 days prior to the day of first injection (Day 1\) or plans to do so while enrolled in this study.
Investigators
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