Health Condition 1: null- Maternal Immunization for Prevention of RSV Lower Respiratory Tract Infection (LRTI) in Infants
Conditions
Interventions
Intervention1: RSV F Vaccine: Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine (Spodoptera frugiperda [Sf9] cells with recombinant Baculovirus expression) with aluminum phosphate a
Sponsors
Novavax Inc Novavax
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant women must meet all of the following criteria to be eligible for participation in the study: 1) >= 18 and 2) Singleton pregnancy of 28 to 360/7 weeks gestation on the day of planned vaccination. Documentation of gestational age will be based on one of the following composite criteria (Note: The investigator should use the earliest ultrasound data available to establish the study specific gestational age dating.): (a) Gestational Age Dating Based on First Trimester Data (data obtained The date of the first day of the reported last menstrual period (LMP) may be used to establish the gestational age if corroborated by a first trimester ultrasound. If the gestational age estimation derived using the LMP and the first trimester ultrasound are discrepant by > 7 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. (b) Gestational Age Dating Based on Early Second Trimester Data (data obtained 140/7 to 216/7): The date of the first day of the reported LMP may be used to establish the gestational age if corroborated by an early second trimester ultrasound (that estimates the gestational age between 140/7 and 216/7 weeks). If the gestational age estimation derived using the LMP and the early second trimester ultrasound are discrepant by > 10 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain of unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. (c) Gestational Age Dating Based on Later Second Trimester Data (data obtained 220/7 to 276/7 weeks by LMP): The date of the first day of the reported LMP may be used to establish the gestational age if corroborated by a later second trimester ultrasound (that estimates the gestational age between 220/7 to 276/7 weeks). If the gestational age estimation derived using the LMP and the later second trimester ultrasound are discrepant by > 14 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy. (d) Gestational Age Dating When the LMP is Uncertain or Unknown AND No Prior First or Second Trimester Ultrasound Has Been Performed: An ultrasound performed at screening within the second trimester ( 3) Documentation of a second or third trimester (between 180/7 weeks and prior to randomization) ultrasound with no major fetal anomalies identified. 4) Good general maternal health as demonstrated by: • Medical history (including history of clinically significant adverse reactions to prior vaccines and allergies). Physical examination including at least vital signs (blood pressure, pulse, respirations, and axillary body temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones. Note that abnormal vital signs may be repeated at the investigatorâ??s discre
Exclusion criteria
Exclusion criteria: Pregnant women will be excluded if there is historical, physical examination, or laboratory evidence of any of the following: 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 > 500 µg per day of beclamethasone or fluticasone, or > 800 μg 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 subjectâ??s prior medical history and the investigatorâ??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 investigatorâ??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. History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy (use of low-dose aspirin as prophylaxis [e.g., for the 19. prevention of morbidity and mortality from preeclampsia] is acceptable in 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 23. Greater than five (5) prior deliveries. 24. Previous infant with a known genetic disor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of RSV LRTI with hypoxemia (SpO2 95% at sea level or 92% at altitudes 1800 meters) in infants through 90 days of life. The primary analysis will consider term infants (â?¥ 37 weeks of gestation at delivery) of mothers who received test article â?¥ 2 weeks prior to deliveryTimepoint: 120, 150 and 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Incidence of RSV LRTI with severe hypoxemia (SpO292% at sea level or 87% at altitudes 1800 meters) or the need of high flow nasal cannula or mechanical ventilator support in infants through 90 days of life, â?¢RSV LRTI with hospitalization in infants through 90 days of life, â?¢RSV LRTI resulting in death in infants through 90 days of life, â?¢RSV LRTI (all severities) in infants through 90 days of life. â?¢healthcare interventions associated with wheezing through the first year of life.Timepoint: 120,150 and 180 days | — |
Countries
Argentina, Australia, Chile, India, Mexico, New Zealand, Philippines, South Africa, Spain, United Kingdom, United States of America
Contacts
Public ContactAbhishek Tyagi
kendle India Pvt. Ltd.
Outcome results
None listed