A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers

Exclusion Criteria

• •Maternal participants Medical conditions
• •History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
• •Hypersensitivity to latex
• •Significant complications in the current pregnancy:
• •Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (\<140mmHg and \<90mmHg) through diet and/or antihypertensive medications
• •Gestational diabetes 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 that can impair the maternal-fetal circulation
• •Polyhydramnios
• •Oligohydramnios
• •Preterm labour or history of preterm labour in the current pregnancy
• •Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
• •Cholestasis
• •Other pregnancy-related complications (per investigator's judgement)
• •Significant structural abnormalities of the uterus or cervix
• •History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions
• •Known HIV infection (as per serological tests performed during the current pregnancy)
• •Known or suspected HBV or HCV 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
• •Known or suspected impairment of the immune system
• •Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
• •Lymphoproliferative disorder or malignancy within 5 years before study vaccination
• •Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
• •Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care
• •Any condition which would increase the risks of study participation to the unborn infant
• •Prior/Concomitant therapy
• •Prior receipt of an RSV vaccine in the current pregnancy
• •Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :
• •For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
• •For immunoglobulins: 3 months before the dose of study vaccine/product.
• •The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery
• •Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
• •Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens, Hepatitis B vaccines, and COVID-19 vaccines all of which may be administered according to standard of care ≥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
• •Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
• •Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
• •Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
• •Corticosteroids administered for fetal lung maturation
• •Prior/Concurrent clinical study experience
• •\- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
• •Other exclusions
• •Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
• •A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
• •Consanguinity of maternal participant and her partner (second degree cousins or closer)
• •Any study personnel or their immediate dependants, family or household members
• •Infant participants
• •Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
• •Any condition which would increase the risks of study participation to the infant
• •Child in care.