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

  • STATUS
    Recruiting
  • End date
    Nov 12, 2023
  • participants needed
    10000
  • sponsor
    Pfizer
Updated on 21 October 2022
lower respiratory tract infection
vaccination
prenatal
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Respiratory Tract Infection
Treatment Placebo, RSVpreF
Clinical Study IdentifierNCT04424316
SponsorPfizer
Last Modified on21 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications
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
Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed
Determined by medical history, physical examination, and clinical judgment to be 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 signed 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 signed 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
Inclusion Criteria -Infant Participants
Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study
Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

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
Preeclampsia, eclampsia, or uncontrolled gestational hypertension
Placental abnormality
Polyhydramnios or oligohydramnios
Significant 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
Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth
Prior pregnancy complications or abnormalities at the time of consent, based on the
investigator's judgment, that will increase the risk associated with the
Prior stillbirth or neonatal death
participation in and completion of the study, including but not limited to the
Previous infant with a known genetic disorder or significant congenital anomaly
following
Prior preterm delivery ≤34 weeks' gestation
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
Major illness of the maternal participant or conditions of the fetus that, in the
investigator's judgment, will substantially increase the risk associated with
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
the maternal or infant participant's participation in, and completion of, the
study or could preclude the evaluation of the maternal participant's response
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
(includes positive serologic testing for regional endemic conditions assessed
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
during routine maternal care, as per local standards of care and obstetric
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
recommendations)
Exclusion Criteria -Infant Participants
Infant who is a direct descendant (eg, child or grandchild) of the study personnel
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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