Phase 2 study

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

• Aged 18 to 29 years on the day of inclusion

• New sex partner within the past 6 months, or more than one current sex partner, or partner with known previous or coexisting sexually transmitted infection (STI), or inconsistent condom use

• A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

  • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be surgically sterile.

OR

• Is of childbearing potential and agrees to use an effective contraceptive method from at least 4 weeks prior to study intervention administration until at least 4 weeks after the last study intervention administration.

• A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) at the screening visit and before each subsequent study intervention administration

Exclusion Criteria:

• Any screening laboratory parameter with laboratory abnormalities as per local reference range and that are greater than Grade 2 or deemed clinically significant in the opinion of the Investigator
• Participants who are Chlamydia trachomatis (CT) and/or Neisseria gonorrhea (NG) NAAT positive at screening visit
• Self-reported or documented seropositivity for HIV antigen and/or antibodies (Abs), hepatitis B virus surface antigen (HBsAg), hepatitis B core antibodies (HBcAbs), or hepatitis C virus (HCV) Abs infection at screening visit
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances
• Previous history of myocarditis, pericarditis, and/or myopericarditis
• Known history of previous history of Guillain-Barre syndrome and other immune mediated demyelinating conditions that include but are not limited to Multiple Sclerosis (MS), Neuromyelitis Optica (NMO), acute disseminated encephalomyelitis (ADEM), Transverse myelitis
• Screening electrocardiogram (ECG) value that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or screening ECG that demonstrates clinically relevant abnormalities, per investigator, that may affect participant safety or study results
• Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
• Moderate or severe acute febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
• Receipt of any mRNA vaccine/product in the 2 months preceding study enrollment or planned receipt of any mRNA vaccine/product within the 2 months following any study intervention administration
• Receipt of any vaccine (other than the study vaccine) in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine (other than the study vaccine) in the 4 weeks following any study intervention administration, except influenza which may be received at least 2 weeks before or 2 weeks after any study vaccination
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months

Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.