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 Short title: A Phase 3 Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
- Conditions
- Respiratory Syncytial Virus (RSV)Virus disease10047438
- Registration Number
- NL-OMON52627
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 217
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
Maternal Participants
Participants are excluded from the study if any of the following criteria
apply:
Weight:
1. Pre-pregnancy body mass index (BMI) of >40 kg/m2. If pre-pregnancy BMI is
not available, the BMI at the time of the first obstetric visit during the
current pregnancy may be used.
Medical Conditions:
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 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.
Prior/Concomitant Therapy:
10. Participation in other studies invol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Babies<br /><br>- To evaluate the efficacy of RSVpreF in reducing the incidence of MA-LRTI due<br /><br>to RSV.<br /><br>- To evaluate the efficacy of RSVpreF in reducing the incidence of severe<br /><br>MA-LRTI due to RSV.<br /><br>- To describe the safety of RSVpreF.<br /><br><br /><br>Mothers<br /><br>- To describe the safety and tolerability of RSVpreF.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Babies<br /><br>- To evaluate the efficacy of RSVpreF in reducing the incidence of<br /><br>hospitalization due to RSV.<br /><br>- To evaluate the efficacy of RSVpreF in reducing the incidence of all-cause<br /><br>MA-LRTI due to RSV.</p><br>