A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 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.
Inclusion Criteria - Maternal Participants:
Inclusion Criteria -Infant Participants:
Exclusion Criteria - Maternal Participants:
Prepregnancy body mass index (BMI) of >40 kg/m2. 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.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
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:
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:
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 results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation.
Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for ≤14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids.
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 (Ig), from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
Previous vaccination with any licensed or investigational RSV vaccine or planned. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study.
Investigator site staff members directly involved in the conduct of the study 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.
Birmingham, Alabama 35233, United States
Los Angeles, California 90095, United States
Los Angeles, California 90095, United States
Madera, California 93637, United States
Cary, North Carolina 27519, United States
Chapel Hill, North Carolina 27514, United States
Chapel Hill, North Carolina 27514, United States
Cincinnati, Ohio 45219, United States
Greenville, South Carolina 29605, United States
Sioux Falls, South Dakota 57105, United States
Sioux Falls, South Dakota 57108, United States
Richmond, Virginia 23219, United States
Tacoma, Washington 98405, United States
Huntington, West Virginia 25701, United States
Huntington, West Virginia 25701, United States
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
CABA, C1426BOS, Argentina
Canoas, Rio Grande do Sul 92425-900, Brazil
Sorocaba, São Paulo 18040-425, Brazil
Osorno, Los Lagos Region 5311523, Chile
Santiago, Santiago Metropolitan 7510186, Chile
Santiago, Santiago Metropolitan 8350488, Chile
Santiago, Santiago Metropolitan 8380456, Chile
Kuwana-shi, Mie-ken 511-0061, Japan
Nakagami-gun, Okinawa 901-2492, Japan
Meguro-ku, Tokyo 152-8902, Japan
Golflands, Auckland 2013, New Zealand
Papakura North, Auckland 2110, New Zealand
Muntinlupa City, National Capital Region 1780, Philippines
Soweto, Gauteng 1862, South Africa
Khayelitsha, Western Cape 7784, South Africa
Parow Valley, Western Cape 7505, South Africa
Fajara KMC, The Gambia