CTRI/2021/10/037383进行中（未招募）3 期
A Phase III, double-blind, randomized, placebocontrolledstudy to evaluate the safety,reactogenicity and immune response of a singleintramuscular dose of unadjuvanted RSV Maternalvaccine, in high risk pregnant women aged 15 to 49years and infants born to the vaccinated mothers.
GlaxoSmithKline Biologicals SA GSK0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •Maternal participants
- •Maternal participants must satisfy ALL the following criteria at study entry:
- •1.Participants who, in the opinion of the investigator, can and will comply with the
- •requirements of the protocol (e.g. completion of diaries, return for follow-up visits).
- •2.Participants and legally acceptable representatives (LARs) who give written or
- •witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should (consistent with local regulations / guidelines) either:
- •â?? include consent for both the maternal participantâ??s participation and
- •participation of the infant after the infantâ??s birth, or
- •â?? include consent for the maternal participantâ??s participation and expressed
- •willingness to consider permitting the infant to take part after the infantâ??s birth
- •(if local regulations/guidelines require parent(s) to provide an additional informed consent after the infantâ??s birth).
- •Written informed consent obtained from parents/LARs and written informed assent
- •obtained from the maternal participant if she is less than legal age, or written
- •informed consent obtained from the participant if the participant has achieved legal
- •age. The legal age is determined according to local regulations in each participating
- •In case the legal age is achieved during the conduct of the study, an additional
- •written informed consent from the maternal participant should be obtained at the
- •time of the legal age.
- •â?? both mother and father should consent if local regulations / guidelines require it.
- •3.Pre-pregnancy Body Mass Index (BMI) (based on participantâ??s report) 18.5 to 39.9
- •kg/m2, inclusive.
- •4. Healthy (as established by medical history and clinical examination) adolescent
- •pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention
- •administration.
- •5. Pregnant women, 18 to 49 YOA, inclusive, at the time of study intervention administration with:
- •- HIV infection (as confirmed by local standard of care serologic tests)
- •â?? Obstetric complications or risk factors during the current pregnancy, where the expectant management of the pregnancy is possible and without evidence of non-reassuring fetal status (only cases for which fetal heart rate can be
- •ascertained) as follows:
- •â?? Gestational diabetes, well-controlled on medications (with or without diet or
- •exercise): i.e. when normoglycemia is maintained (fasting or preprandial
- •blood glucose values <95 mg/dL [5.3 mmol/L], and/or postprandial blood
- •glucose concentration <140 mg/dL [7.8 mmol/L] at 1 hour and/or
- •postprandial blood glucose concentration: <120 mg/dL [6.7 mmol/L] at 2
- •- Gestational hypertension, well-controlled on diet or medications below 160/110 mmHg
- •- Pre-eclampsia without severe features (i.e. eclampsia, severe hypertension [ >160/110 mmHg], organ dysfunction, unstable or complicated by
- •Hemolysis, Elevated Liver enzymes, and Low Platelets [HELLP] syndrome).
- •- Fetal Growth Restriction in singleton pregnancies, with normal umbilical artery (UA) Doppler and estimated fetal weight 3 to 10th percentile for ge
排除标准
- •Maternal participants
- •1.Medical conditions
- •-History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
- •-Hypersensitivity to latex.
- •-Any pre-existing medical conditions or obstetric complications in the current pregnancy that, based on the investigators clinical judgment, are poorly controlled and or with clinical evidence of a non-reassuring fetal status and or are likely to result in delivery within 7 days after study intervention administration and or when the timing of planned delivery is within 7 days after study intervention administration and or acute conditions requiring immediate medical attention for maternal stabilization and or treatment.
- •-A multiple pregnancy with 3 or more fetuses.
- •-Complicated twin gestation (e.g twin to twin transfusion syndrome or fetal growth
- •restriction).
- •-Placenta Accreta Spectrum, including placenta increta, percreta, and accreta.
- •-Fetal structural defects or genetic abnormalities that affect (or are likely to affect) fetal health or survival during the first year of life.
- •-Known or suspected impairment of the immune system or immunodeficiency syndrome other than HIV.
- •-Lymphoproliferative disorder or malignancy within 5 years before study dose administration (excluding effectively treated non-melanoma skin cancer).
- •-Any illness of the mother or conditions of the fetus that, in the investigators judgment, may substantially interfere with the maternal participants ability to comply with study procedures, or could increase the risks to the mother or the fetus, or could preclude the evaluation of the participants data.
- •-Any other clinical condition that, in the opinion of the investigator, might pose
- •additional risk to the participant due to participation in the study, as determined by
- •medical history, physical examination or laboratory screening tests.
- •-Women with any diagnosis, condition, treatment, or other factor that, in the opinion of the investigator, has the potential to affect or confound assessments of immunogenicity or safety
- •-Any conditions which, in the investigators opinion, would increase the risks of study participation to the unborn infant.
- •2. Prior/Concomitant therapy
- •- Prior receipt of an RSV maternal vaccine.
- •- Use of any investigational or non-registered product (drug, vaccine or medical
- •device) other than the study intervention(s) during the period beginning-
- •â?? For a drug, vaccine or medical device - 29 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
- •â?? For immunoglobulins - 90 days before the dose of study intervention(s), or their
- •planned use during the study period.
- •The exception to this is investigational products (drugs or vaccines or immunoglobulins) administered in the setting of a pandemic. Administration in this case should respect the same period outlined above prior to study intervention administration, but may be allowed following delivery.
- •-Planned administration or administration of a vaccine not foreseen by the study
- •protocol in the period starting 29 days before the study Day 1 and ending at delivery,
- •with the exception of seasonal influenza vaccines, tetanus vaccines, dTpa or Tdap â?? alone vaccines, dTpa or Tdap vaccines that also contain other antigens
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