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Study record managers: refer to the Data Element Definitions if submitting registration or information.
Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:. Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:.
Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study. Warning You have reached the maximum of saved studies The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : September 28, See Contacts and Locations. Study Description. This randomized, double-blinded, placebo-controlled Phase 3 study is deed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness MA-LRTI in infants.
Detailed Description:. This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo randomization in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons. Arms and Interventions. Outcome Measures. Describe specific birth outcomes for infant participants. Describe AE for infant participants from birth to 1 month of age.
Describe local reactions and systemic events after vaccination. Describe serious adverse events from enrolment up to days after delivery. Secondary Outcome Measures : The percentage reduction in the incidence of hospitalizations due to RSV in infants through days of life [ Time Frame: Delivery to days after delivery ] The percentage relative risk reduction in the incidence of hospitalization due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants. The percentage relative risk reduction in the incidence of all-cause MA-LRTI in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants.
Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Accepts Healthy Volunteers: Yes Criteria. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Receiving prenatal standard of care based on country requirements. Determined by medical history, physical examination, and clinical judgment to Fre adult chat 11501 cruz appropriate for inclusion in the study.
Documented negative HIV antibody test, syphilis test, and hepatitis B virus HBV surface antigen test during this pregnancy and prior to randomization Visit 1. Intention to deliver at a hospital or birthing facility where study procedures can be obtained. Expected to be available for the duration of the study and can be contacted by telephone during study participation. Participant is willing to give informed consent for her infant to participate in the study.
Capable of giving ed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document ICD and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be ed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.
If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. Current pregnancy resulting from in vitro fertilization. Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following: Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
Placental abnormality. Polyhydramnios or oligohydramnios. ificant bleeding or blood clotting disorder. Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance eg, diabetes mellitus type 1 or 2 antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent. Prior stillbirth or neonatal death. infant with a known genetic disorder or ificant congenital anomaly.
Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations.
Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment. Other acute or chronic medical or psychiatric condition including recent within the past year or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study and, in the judgment of the investigator, would Fre adult chat 11501 cruz the participant inappropriate for entry into this study.
Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales. Receipt of blood or plasma products or immunoglobulin Igfrom 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho D immune globulin eg, RhoGAMwhich can be given at any time.
vaccination with any d or investigational RSV vaccine or planned. Investigator site staff members directly involved in the conduct of the Fre adult chat 11501 cruz and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study. Participants who are breastfeeding at the time of enrollment.
Exclusion Criteria -Infant Participants: o Infant who is a direct descendant eg, child or grandchild of the study personnel. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Layout table for location contacts Contact: Pfizer CT. Kurian, M. Ugwu-Oju, M. Alvin H. More Information. Additional Information: To obtain contact information for a study center near you.
National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. Respiratory Tract Infection. Phase 3. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. This is a double-blinded, placebo-controlled study.
Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Placebo Comparator: Placebo dose Placebo. Biological: Placebo Placebo. Huntington Park, California, United States, Charles E. University of Colorado Anschutz Inpatient Pavilion 2. Washington, District of Columbia, United States, Loxahatchee Groves, Florida, United States, Mary Medical Center Labor and Delivery. Hershey Medical Center. Philadelphia, Pennsylvania, United States, West Reading, Pennsylvania, United States, Charleston, South Carolina, United States, Greenville, South Carolina, United States, Summerville, South Carolina, United States, University Hospital - University Health System delivery.
Cosme Argerich. North Adelaide, South Australia, Australia, Seongnam-si, Gyeonggi-do, Korea, Republic of, Asociacion Mexicana para la Investigacion Clinica, A. Hospital Universitario "Dr. Jose Eleuterio Gonzalez". Hillbrow, Johannesburg, Gauteng, South Africa, C EudraCT.
June 9, Key Record Dates. Pfizer will provide access to individual de-identified participant data and related study documents e.Fre adult chat 11501 cruz
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