Pregnancy related outcomes and events in maternal participants who were vaccinated against RSV or received control, and in their infants MedDRA version: 20.0 Level: PT Classification code 10070538 Term: Gestational hypertension System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 20.0 Level: PT Classification code 10036485 Term: Pre-eclampsia System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions MedDRA version: 25.0 Level: LLT C
Conditions
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the incidence of pregnancy outcomes, pregnancy related adverse events of special interest (AESIs) and infant AESIs during the first pregnancy conceived within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery.;Secondary Objective: • To describe the incidence of pregnancy outcomes, pregnancy related AESIs and infant AESIs during any pregnancy conceived within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to Day 42 post-delivery. • To describe the incidence of selected pregnancy outcomes, pregnancy related AESIs and infant AESIs by risk status and by selected risk factors for or causes of those events/outcomes during pregnancies conceived within 2 years post-vaccination in participants enrolled in RSV MAT studies (by study arm, those previously received RSVPreF3 and control) up to day 42 post-delivery. ;Primary end point(s): 1. Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 2. Percentage of maternal participants reporting pregnancy related adverse events of special interest (AESIs) from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination;Timepoint(s) of evaluation of this end point: 1. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 2. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 3. From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination 2. Percentage of maternal participants reporting pregnancy related AESIs from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination 3. Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination 4. Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination 5. Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination 6. Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination 7. Percentage of maternal participants reporting selected pregnancy outcomes stratified by selected risk factors of those outcomes, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 8. Percentage of maternal participants reporting pregnancy related AESIs stratified by selected risk factors of those events, from Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination 9. Percentage of infant participants reporting infant AESIs stratified by selected risk factors of those events, from birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination;Timepoint(s) of evaluation of this end point: 1, 2, 4, 5. From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vacci | — |
Countries
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican Republic, Finland, France, Germany, Honduras, India, Italy, Korea, Republic of, Mexico, New Zealand, Panama, Philippines, South Africa, Spain, Taiwan, Thailand, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed