跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NL-OMON52627
NL-OMON52627已完成3 期

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. - 9002/0610 (C3671008)

Pfizer0 个研究点目标入组 217 人开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
217
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
12 至 64（—）

入选标准

  • •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
  • •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
  • 另有 1 项未显示

排除标准

  • •Maternal Participants
  • •Participants are excluded from the study if any of the following criteria
  • •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
  • •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
  • •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
  • •Prior preterm delivery <=34 weeks' gestation.
  • •Prior stillbirth or neonatal death.
  • •Previous infant with a known genetic disorder or significant congenital
  • •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.
  • 另有 2 项未显示

研究者

发起方
Pfizer

相似试验

已完成
3 期
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.Respiratory Tract Infection
JPRN-jRCT2031200167Kawai Norisuke6,900
已完成
不适用
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF ARQ 197 PLUS ERLOTINIB VERSUS PLACEBO PLUS ERLOTINIB IN PREVIOUSLY TREATED SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC, NON-SQUAMOUS, NON-SMALL-CELL LUNG CANCER (NSCLC)
PER-025-11DAIICHI SANKYO PHARMA DEVELOPMENT,11
进行中（未招募）
1 期
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 PREGNANCYPrevention 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: 100000004865
EUCTR2019-002943-85-DKPfizer Inc10,000
进行中（未招募）
1 期
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
EUCTR2019-002943-85-NLPfizer Inc., 235 East 42nd Street, New York, NY 100176,900
未知
不适用
A PHASE III, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-TITRATION STUDY TO ASSESS THE EFFICACY, SAFETY AND PHARMACOKINETICS OF INTRAVENOUS CONIVAPTAN (VAPRISOL®) IN PEDIATRIC SUBJECTS WITH EUVOLEMIC OR HYPERVOLEMIC HYPONATREMIA
PER-027-12Astellas Pharma Global Development, Inc. (APGD-US),