A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy

Exclusion Criteria

• •Maternal participants
• •Medical conditions
• •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
• •Hypersensitivity to latex.
• •Acute or chronic clinically significant abnormality or poorly controlled pre-existing condition or any other clinical conditions.
• •Subjects who have received 2 or more doses of any RSV vaccine in the past.
• •Significant complications in the current pregnancy such as:
• •* Gestational hypertension at ≥20 weeks of gestation in the absence of proteinuria in a woman with a previously normal blood pressure.
• •* Gestational diabetes which is not controlled by medication, diet and/or exercise
• •* Pre-eclampsia
• •* Eclampsia
• •* Intrauterine Growth Restriction/Fetal Growth Restriction
• •* Placenta previa
• •* Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities
• •* Polyhydramnios
• •* Oligohydramnios
• •* Preterm labor or history of preterm labor in the current pregnancy.
• •* Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery
• •* Cholestasis
• •* Other pregnancy-related complications
• •History of 2 or more prior stillbirths or neonatal deaths, or history of 2 or more preterm births at ≤ 34 weeks gestation, or 3 or more consecutive spontaneous abortions.
• •Significant structural abnormalities of the uterus or cervix.
• •Known human immunodeficiency virus infection, as assessed by local standard of care serologic tests.
• •Known or suspected hepatitis B or C virus infection.
• •Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex.
• •Active infection with tuberculosis.
• •Any confirmed or suspected immunosuppressive or immunodeficient condition.
• •Current autoimmune disorder.
• •Lymphoproliferative disorder or malignancy within 5 years before study vaccination.
• •Any conditions that, in the investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of prenatal care.
• •Any condition which, in the investigator's opinion, would increase the risks of study participation to the unborn infant.
• •Prior/Concomitant therapy
• •Prior receipt of any RSV vaccine in the current pregnancy or prior receipt of 2 or more doses of any RSV vaccine prior to study vaccination.
• •Use of any investigational or non-registered product other than the study vaccine/product, or planned use during the study period).
• •The exception to this are investigational products administered in the setting of a pandemic.
• •Planned administration/administration of any vaccine within 29 days before study vaccine administration (Day -28 to Day 1) or planned administration through delivery, except:
• •* Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, which may be administered ≥ 15 days before or after study vaccination.
• •* Note that if public health authorities organize an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) outside the routine immunisation program, then the intervals described above can be reduced if necessary for that mass vaccination vaccine, provided the vaccine is licensed and used according to its Product Information. In that sense, COVID-19 vaccines may be allowed, when administered ≥ 15 days before or after study vaccination.
• •Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery (Visit 3).
• •Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery.
• •Prior/Concurrent clinical study experience
• •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.
• •Subjects who were lost to follow-up or prematurely withdrawn before Day 43 in the RSV MAT-004, RSV MAT-009 and RSV MAT-012 studies.
• •Other exclusions
• •Alcoholism or substance use disorder within the past 24 months based on the presence of 2 or more abuse criteria.
• •A local condition that in the opinion of the Investigator precludes injection of the study vaccine/product or precludes assessment of local (administration site) reactogenicity.
• •Consanguinity of maternal participant and her partner.
• •Any study personnel or their immediate dependents, family, or household members.
• •Infant participants
• •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.
• •Any condition which, in the investigator's opinion, would increase the risks of study participation to the infant.
• •Child in care.