A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Exclusion Criteria

• •1. Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose \>500µg per day of beclomethasone or fluticasone, or \>800μg per day of budesonide.
• •2. Pregnancy complications (in the current pregnancy) such as preterm labor, hypertension (blood pressure \[BP\] \>140/90 in the presence of proteinuria or BP \>150/100 with or without proteinuria) or currently on an antihypertensive therapy or pre-eclampsia; or evidence of intrauterine growth restriction.
• •3. Grade 2 or higher clinical laboratory or vital sign abnormality. Exclusion of subjects with grade 1 abnormalities will be based on the subject's prior medical history and the investigator's clinical judgment that the abnormality is indicative of a meaningful physiologic event.
• •4. Receipt of any licensed vaccine (e.g., Tdap, inactivated influenza vaccine) within 14 days of study vaccination.
• •5. Received any RSV vaccine at any time.
• •6. Body mass index (BMI) of ≥40, at the time of the screening visit.
• •7. Hemoglobinopathy (even if asymptomatic) or blood dyscrasias.
• •8. Hepatic or renal dysfunction.
• •9. Established diagnosis of seizure disorder, regardless of therapy.
• •10. Known, active auto-immune disease or immunodeficiency syndrome.
• •11. Endocrine disorders, including (but not limited to) untreated hyperthyroidism, untreated hypothyroidism (unless due to auto-immune disease), and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
• •12. History of major gynecologic or major abdominal surgery, including bariatric surgery (previous Caesarean section is not an exclusion).
• •13. Known HIV, syphilis, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
• •14. Primary genital Herpes simplex virus (HSV) infection during the current pregnancy.
• •15. Current alcohol or drug abuse based on the Investigator's knowledge of present or recent (within the last 2 years) use/abuse of alcohol or illegal or non-prescription drugs.
• •16. Documentation that the current pregnancy results from in vitro fertilization (IVF).
• •17. Documentation that the current pregnancy results from rape or incest.
• •18. Documentation that the infant will be a ward of the state or be released for adoption.
• •19. History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy (the use of low-dose aspirin as prophylaxis \[e.g., for the prevention of morbidity and mortality from preeclampsia\] is acceptable is dosages consistent with local standards of care).
• •20. Red blood cell allo-immunization.
• •21. Prior stillbirth or neonatal death, or multiple (≥3) spontaneous abortions.
• •22. Prior preterm delivery ≤34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth.
• •23. Greater than five (5) prior deliveries.
• •24. Previous infant with a known genetic disorder or major congenital anomaly.
• •25. Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine.
• •26. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in exclusion criterion #1.
• •27. Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs (excluding treatment for depression and anxiety).
• •28. Any other physical, psychiatric or social condition which may, in the investigator's opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data.
• •29. Acute disease within 72 hours of the day of the planned vaccination (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C).
• •30. History of a serious adverse reactions (e.g., anaphylaxis) to any prior vaccine.