The purpose of this follow-up study is 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 will be administered in this study. The exposure was the intervention (either RSVPreF3 vaccine or control) received by the study participants in the above-mentioned prior RSV MAT studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3,962
No intervention is administered in this extension study. Participants received the RSVPreF3 vaccine during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.
No intervention is administered in this extension study. Participants received any control (placebo, Tdap or influenza vaccine) during the prior 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) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of any control (placebo, Tdap or influenza vaccine).
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
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Tucson, Arizona, United States
GSK Investigational Site
Burbank, California, United States
GSK Investigational Site
Los Angeles, California, United States
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
Time frame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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
Time frame: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
Percentage of infant participants reporting infant AESIs from birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
Time frame: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination
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
Time frame: From birth up to Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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
Time frame: From Day 1 up to Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination
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
Time frame: From birth up to Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination
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GSK Investigational Site
Nampa, Idaho, United States
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Nampa, Idaho, United States
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Covington, Louisiana, United States
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Slidell, Louisiana, United States
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Detroit, Michigan, United States
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