None listed
Conditions
Interventions
None listed
Sponsors
GSK Research and Development Limite
Eligibility
Inclusion criteria
Inclusion criteria: Adult study participant from RSV-MAT-011, RSV MAT-010, RSV MAT-009, RSV MAT-012 or RSV MAT-039 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
Exclusion criteria
Exclusion criteria: Adult participant otherwise eligible for the prospective cohort: Woman of Nonchildbearing Potential (WONCBP) as defined in Section 10.3.1.2 at study enrollment, or recipient of bilateral tubal ligation prior to study enrollment, if she has not conceived a pregnancy post-vaccine/control. Infant participant: Child in care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. % of maternal participants reporting pregnancy outcomes from Day 1 up to Day 42 post-delivery of the first pregnancy conceived post vaccination. 2. % 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 post-vaccination. 3. % of infant participants reporting infant AESIs from birth up to Day 42 post-birth of the first pregnancy conceived post vaccination.Timepoint: 1. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination 2. From Day 1 up to Day 42 post-delivery of the first pregnancy conceived post-vaccination 3. From birth up to Day 42 post-birth of the first pregnancy conceived post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. % of maternal participants reporting pregnancy outcomes from D1 up to D42 post-delivery of any pregnancy conceived post vaccination 2. % of maternal participants reporting pregnancy related AESIs from D1 up to D42 post-delivery of any pregnancy conceived post vaccination 3. % of infant participants reporting infant AESIs from birth up to D42 post-birth of any pregnancy conceived post vaccinationTimepoint: 1. From Day 1 up to Day 42 post-delivery of any pregnancy conceived post vaccination 2. From Day 1 up to Day 42 post-delivery of any pregnancy conceived post vaccination 3. From birth up to Day 42 post-birth of any pregnancy conceived post vaccination 4. Time Frame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived post vaccination. | — |
Countries
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican Republic, Finland, France, Germany, Honduras, India, Italy, Mexico, New Zealand, Panama, Philippines, Republic of Korea, South Africa, Spain, Taiwan, Thailand, United States of America
Contacts
Public ContactSwapnali Raut
GlaxoSmithKline Pharmaceuticals Limited
Outcome results
None listed