A 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
- Conditions
- Prevention of medically attended Respiratory Syncytial Virus-associated lower respiratory tract illness (LRTI) in infants by active immunization of pregnant womenMedDRA version: 21.1Level: LLTClassification code 10066742Term: Respiratory syncytial virus infection prophylaxisSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2019-002943-85-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10000
Maternal Participants
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. 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.
a. First-trimester data available (data obtained at =13 6/7 weeks):
•The date of the first day of the reported LMP may be used to establish the GA if corroborated by a first-trimester ultrasound examination.
•If there is a discrepancy of >5 days between the LMP-determined GA and an ultrasound result at =8 6/7 weeks OR the LMP is uncertain/unknown, then the GA should be determined using the first-trimester ultrasound result.
•If there is a discrepancy of >7 days between the LMP-determined GA and an ultrasound result at 9 0/7 to 13 6/7 weeks OR the LMP is uncertain/unknown, then the GA should be determined using the first-trimester ultrasound result.
b. Second-trimester data available (data obtained at 14 0/7 to 27 6/7 weeks):
•The date of the first day of the reported LMP may be used to establish the GA if corroborated by a second-trimester ultrasound result.
•If there is a discrepancy of >7 days between the LMP-determined GA and the ultrasound result at 14 0/7 to 15 6/7 weeks OR if the LMP is uncertain/unknown, then the GA should be determined using the second-trimester ultrasound result.
•If there is a discrepancy of >10 days between the LMP-determined GA and the ultrasound result at 16 0/7 to 21 6/7 weeks OR if the LMP is uncertain/unknown, then the GA should be determined using the second-trimester ultrasound result.
•If there is a discrepancy of >14 days between the LMP-determined GA and the ultrasound result at 22 0/7 to 27 6/7 weeks OR if the LMP is uncertain/unknown, then the GA should be determined using the second-trimester ultrasound result.
Type of Participant and Disease Characteristics
2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Receiving prenatal standard of care based on country requirements.
4. Had a fetal anomaly ultrasound examination performed at =18 weeks of pregnancy with no significant fetal abnormalities observed.
5. Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
6. Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
7. Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
8. Expected to be available for the duration of the study and can be contacted by telephone during study participation.
9. Participant is willing to give informed consent for her infant to participate in the study.
Informed Consent
10. Capable of giving signed informed consent as described in Appendix 1, 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 thumb-printed 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
1. Evidence of a signed and dated ICD si
Maternal Participants
Participants are excluded from the study if any of the following criteria apply
1. 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
2. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
3. 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
4. Current pregnancy resulting from in vitro fertilization. Participants known to have used clomiphene citrate and/or letrozole with or without intrauterine insemination (IUI) are permitted
5. 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
6. 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
•Prior preterm delivery =34 weeks' gestation
•Prior stillbirth or neonatal death
•Previous infant with a known genetic disorder or significant congenital anomaly
7. 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)
8. 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
9. 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
10. Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation
11. 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. Pe
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method