EUCTR2022-003124-41-BE招募中1 期
A Phase 3b, non-randomized, open label, multi-country, cohort study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) during any pregnancy conceived post vaccination/control. - RSV MAT-015
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 4,187
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
- 性别
- Female
入选标准
- •Retrospective cohort
- •Adult/Adolescent Participant:
- •Adult/Adolescent study participant, from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
- •Study participant:
- •-who has reached 2 years+2 months post vaccine/control prior to/at enrolment or
- •-who has not reached 2 years+2 months post vaccine/control prior to/at enrolment but is a Woman of Nonchildbearing Potential (WONCBP) at study enrolment, or recipient of bilateral tubal ligation prior to study enrolment.
- •Study participant with any pregnancy conceived post vaccination/control, that has reached Day 42 post-delivery prior to/at enrollment.
- •Provide signed and dated informed consent form.
- •Be willing to comply with all study requirements and be available for the duration of the study.
- •Infant Participant:
- •Participant live born as the result of a pregnancy followed in an adult/adolescent participant in this study.
- •Signed and dated informed consent form obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
- •Prospective cohort
- •Adult/Adolescent Participant:
- •Adult/adolescent study participant from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine).
- •Study participant:
- •-who has not reached 2 years+2 months post vaccine/control prior to/at enrollment or
- •-who has reached at least 2 years+2 months post vaccine/control but has an ongoing pregnancy (prior to Day 42 post-delivery) at enrollment. Participants who have reached 2 years post-vaccine/control before enrollment but are pregnant at enrollment will be enrolled and followed until Day 42 post-delivery for the pregnancy ongoing at enrollment.
- •Female participants of childbearing potential
- •Provide signed and dated informed consent form.
- •Be willing to comply with all study procedures and be available for the duration of the study.
- •Infant Participant:
- •Participant live born as the result of a pregnancy followed in an adolescent/adult participant in this study
- •Participant’s parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol
- •Signed and dated informed consent form obtained from the participant’s parent(s)/LAR(s) prior to performance of any study-specific procedure.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Adult/adolescent participant otherwise eligible for the prospective cohort:
- •Woman of Nonchildbearing Potential (WONCBP) at study enrollment, or recipient of bilateral tubal ligation prior to study enrollment, if she has not conceived a pregnancy post-vaccine/control and does not plan to use any additional measures to attempt to conceive a pregnancy (e.g., sterilization reversal or IVF).
- •Infant participant:
- •Child in care
研究者
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