A PHASE 3, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, GROUP-SEQUENTIAL STUDY TO DETERMINE THE IMMUNOGENICITY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) F NANOPARTICLE VACCINE WITH ALUMINUM IN HEALTHY THIRD-TRIMESTER PREGNANT WOMEN; AND SAFETY AND EFFICACY OF MATERNALLY TRANSFERRED ANTIBODIES IN PREVENTING RSV DISEASE IN THEIR INFANTS
The primary objective of this study is: To determine the efficacy of maternal immunization with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI) with EITHER hypoxemia (peripheral oxygen saturation [SpO2] < 95% at sea level or < 92% at altitudes > 1800 meters) OR tachypnea (≥ 70 bpm for infants 0 to 59 days of age or ≥ 60 bpm for infants ≥ 60 days of age) through the first 90 days of life in infants of maternal RSV F vaccinees as compared to placebo recipients. In the event that efficacy is shown through the first 90 days of life, a hierarchical sequence of hypothesis tests will be carried out to examine efficacy at 120, 150, and 180 days of life.
This Study is
No Longer Enrolling
Child to Adult
Pregnant women between 18 and 40 years old with a singleton pregnancy of 28 to 36 and 0/7 weeks gestation on the day of planned vaccination.
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Treatment
University of Colorado Hospital
Protocol Number: 18-1121
More information available at ClinicalTrials.gov: NCT02624947
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