A follow-up study to describe the safety of study participants who received RSVPreF3 maternal vaccination (any dose) or controls from previous RSV MAT studies during any pregnancy conceived post vaccination/control
Trial overview
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
Timeframe: From conception 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 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
Timeframe: From conception until Day 42 post-delivery of the first 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 the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Timeframe: From birth until Day 42 post-birth 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 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
Timeframe: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Participation criteria
- Retrospective cohort
- Adult/Adolescent Participant:
- 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).
- 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
- 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
- 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.
Retrospective cohort Adult/Adolescent Participant:
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.
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.
- 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.
Adult/adolescent participant otherwise eligible for the prospective cohort:
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
To view plain language summaries on trialsummaries.com click here.