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
概览
- 阶段
- 3 期
- 干预措施
- RSV MAT Group - Infant
- 疾病 / 适应症
- Respiratory Syncytial Virus Infections
- 发起方
- GlaxoSmithKline
- 入组人数
- 3855
- 试验地点
- 138
- 主要终点
- Number of Maternal Participants With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study.
The study participants enrolled in this follow-up study received RSVPreF3 maternal vaccination (any dose) or controls during the following prior RSV MAT studies: RSV MAT-001 (NCT03674177), RSV MAT-004 (NCT04126213), RSV MAT-010 (NCT05045144), RSV MAT-011 (NCT04138056), RSV MAT-009 (NCT04605159), RSV MAT-012 (NCT04980391) and RSV MAT-039 (NCT05169905).
No intervention was administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the abovementioned prior RSV MAT studies.
研究者
入排标准
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:
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.
研究组 & 干预措施
RSV MAT Group - Infant
This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.
Control Group - Infant
This group consisted of infants live-born to maternal participants in the Control Group - Mother.
RSV MAT Group - Mother
Maternal participants who received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
干预措施: RSVPreF3 vaccine
Control Group - Mother
Maternal participants who received any control (placebo, Tdap or influenza vaccine) during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-009, RSV MAT-010, RSV MAT-011, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study.
干预措施: Control
结局指标
主要结局
Number of Maternal Participants With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
时间窗: From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Assessed pregnancy outcomes were live infant with no apparent congenital anomaly; spontaneous abortion with no apparent congenital anomaly; ectopic pregnancy; elective termination with no apparent congenital anomaly; live infant with congenital anomaly, and stillbirth with congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.
Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Conception Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
时间窗: From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Assessed pregnancy-related AESIs were chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, premature preterm ruptures of membranes, preterm labor and provider-initiated preterm birth. Due to the character limit, further description is added here instead of Analysis population description field: 1 participant in the Control group - Mother was excluded from this outcome's analysis as the gestational age was not provided and hence conception date, which is required for this outcome measure, could not be calculated.
Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies
时间窗: From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Assessed AESIs were congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, low birth weight \[greater than or equal to (\>=) 1500 grams (G) and below (\<) 2500 G\], very low birth weight (\>=1000 G and \<1500 G), neonatal death in a term live birth (\>=37 weeks of gestational age), preterm birth (\<37 weeks of gestational age) and small for gestational age.
次要结局
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Age Group at Vaccination, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Pregnancy Outcomes From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Pregnancy-related AESIs From Conception Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Infant Participants With AESIs From Birth Until Day 42 Post-birth of Any Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Selected Risk Factors, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Age Group at Vaccination, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Pre-pregnancy BMI, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Race, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Economic Region, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Multiple Gestation Pregnancy, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Geographic Region, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Pregnancies With Preterm Birth Event Data Stratified by Economic Region, From Day 1 Until Day 42 Post-delivery of Any Pregnancy Conceived by Maternal Participants Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Selected Risk Factors, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Pre-pregnancy BMI Group, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Race, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Multiple Gestation Pregnancy, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)
- Number of Maternal Participants With Preterm Birth Event Data Stratified by Geographic Region, From Day 1 Until Day 42 Post-delivery of the First Pregnancy Conceived Within 2 Years Post-vaccination Received in Prior RSV MAT Studies(From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies)