A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
NCT04424316
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Maternal Participants:
- Healthy women 18 to 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 an ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed, based on the investigator's judgment.
- 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.
-Infant Participants:
o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy. | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. | ||||||
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 (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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: This is a double-blinded, placebo-controlled study. Primary Purpose: Prevention
| ||||||
Condition ICMJE | Respiratory Tract Infection | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 6900 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 31, 2023 | ||||||
Estimated Primary Completion Date | August 31, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria - Maternal Participants:
Inclusion Criteria -Infant Participants:
Exclusion Criteria - Maternal Participants:
Exclusion Criteria -Infant Participants: o Infant who is a direct descendant (eg, child or grandchild) of the study personnel. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years to 49 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
| ||||||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Netherlands, New Zealand, South Africa, Spain, Taiwan, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04424316 | ||||||
Other Study ID Numbers ICMJE | C3671008 2019-002943-85 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |