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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 vaccine; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 3855
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • GSK Investigational Site
  • Córdoba, Argentina, 5800
    • GSK Investigational Site
• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • GSK Investigational Site
    • Southport, Queensland, Australia, 4215
      • GSK Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • GSK Investigational Site
• Bangladesh
  • Matlab, Bangladesh
    • GSK Investigational Site
  • Sylhet, Bangladesh, 3100
    • GSK Investigational Site
• Belgium
  • Ghent, Belgium, 9000
    • GSK Investigational Site
  • Leuven, Belgium, 3000
    • GSK Investigational Site
  • Sint-Niklaas, Belgium, 9100
    • GSK Investigational Site
• Brazil
  • Nova Iguaçu, Brazil, 26030-380
    • GSK Investigational Site
  • Porto Alegre, Brazil, 90035001
    • GSK Investigational Site
  • RibeirAo PretoSP, Brazil, 14051-140
    • GSK Investigational Site
  • Santa Maria, Brazil, 97105-900
    • GSK Investigational Site
  • São José do Rio Preto, Brazil, 15090-000
    • GSK Investigational Site
• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3S 2N6
      • GSK Investigational Site
    • Vancouver, British Columbia, Canada, V6Z 2T1
      • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
    • Truro, Nova Scotia, Canada, B2N 1L2
      • GSK Investigational Site
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • GSK Investigational Site
    • London-Ontario, Ontario, Canada, N5W 6A2
      • GSK Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M9W 4L6
      • GSK Investigational Site
  • Quebec
    • Joliette, Quebec, Canada, J6E 6A9
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H3T 1C5
      • GSK Investigational Site
    • Montreal, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Montreal, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1V 4G2
      • GSK Investigational Site
    • Québec, Quebec, Canada, G1W 4R4
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • GSK Investigational Site
• Colombia
  • Barranquilla, Colombia, 760002
    • GSK Investigational Site
  • Cali Colombia, Colombia, 760042
    • GSK Investigational Site
  • Chía, Colombia, 250001
    • GSK Investigational Site
  • Medellín, Colombia, 050034
    • GSK Investigational Site
• Dominican Republic
  • Santo Domingo Este, Dominican Republic
    • GSK Investigational Site
• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Helsinki, Finland, 00290
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Seinäjoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• France
  • Bordeaux, France, 33000
    • GSK Investigational Site
  • Bron, France, 69500
    • GSK Investigational Site
  • Paris, France, 75679
    • GSK Investigational Site
• Germany
  • Goch, Germany, 47574
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hanover, Germany, 30159
    • GSK Investigational Site
  • Mainz, Germany, 55116
    • GSK Investigational Site
  • Würzburg, Germany, 97070
    • GSK Investigational Site
• Honduras
  • Comayagua, Honduras
    • GSK Investigational Site
  • San Pedro Sula, Honduras, 21101
    • GSK Investigational Site
• India
  • Kolkata, India, 700017
    • GSK Investigational Site
  • Mangalore, India, 575001
    • GSK Investigational Site
  • Mysore, India, 570015
    • GSK Investigational Site
  • Nagpur, India, 441108
    • GSK Investigational Site
  • Pune, India, 411043
    • GSK Investigational Site
  • Vadu Budruk Pune, India, 412216
    • GSK Investigational Site
• Italy
  • Bari, Italy, 70124
    • GSK Investigational Site
  • Messina, Italy, 98124
    • GSK Investigational Site
  • Milan, Italy, 20154
    • GSK Investigational Site
  • Prato, Italy, 59100
    • GSK Investigational Site
• New Zealand
  • Grafton Auckland, New Zealand, 1010
    • GSK Investigational Site
  • Papatoetoe Auckland, New Zealand, 1701
    • GSK Investigational Site
  • Wellington, New Zealand, 6002
    • GSK Investigational Site
• Panama
  • Panama City, Panama, 1001
    • GSK Investigational Site
  • Panama City, Panama, 7099
    • GSK Investigational Site
  • Panama City, Panama, 07079
    • GSK Investigational Site
  • Panama City, Panama, 0801
    • GSK Investigational Site
• Philippines
  • Manila, Philippines, 1000
    • GSK Investigational Site
  • Manila, Philippines, 1008
    • GSK Investigational Site
• South Africa
  • Johannesburg, South Africa, 2112
    • GSK Investigational Site
  • Pretoria, South Africa, 0184
    • GSK Investigational Site
  • Soshanguve, South Africa, 0152
    • GSK Investigational Site
  • Soweto Gauteng, South Africa, 2013
    • GSK Investigational Site
• South Korea
  • Ansan, South Korea, 425-707
    • GSK Investigational Site
  • Seoul, South Korea, 08308
    • GSK Investigational Site
  • Seoul, South Korea
    • GSK Investigational Site
• Spain
  • Aravaca, Spain, 28023
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Bilbao, Spain, 48013
    • GSK Investigational Site
  • Boadilla Del Monte Madrid, Spain, 28660
    • GSK Investigational Site
  • Burgos, Spain, 09006
    • GSK Investigational Site
  • Getafe, Spain, 28905
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28006
    • GSK Investigational Site
  • Madrid, Spain, 28007
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Madrid, Spain, 28400
    • GSK Investigational Site
  • Marbella, Spain, 29603
    • GSK Investigational Site
  • Málaga, Spain, 29004
    • GSK Investigational Site
  • Santiago de Compostela, Spain, 15706
    • GSK Investigational Site
  • Seville, Spain, 41013
    • GSK Investigational Site
  • Seville, Spain, 41014
    • GSK Investigational Site
  • TorrejOn Ardoz Madrid, Spain, 28850
    • GSK Investigational Site
  • Valencia, Spain, 46017
    • GSK Investigational Site
  • Valencia, Spain, 46020
    • GSK Investigational Site
  • Valencia, Spain, 46702
    • GSK Investigational Site
  • Valladolid, Spain, 47012
    • GSK Investigational Site
• Taiwan
  • Taichung, Taiwan, 40447
    • GSK Investigational Site
  • Taipei, Taiwan, 10041
    • GSK Investigational Site
  • Taipei, Taiwan, 0105
    • GSK Investigational Site
  • Taoyuan District, Taiwan, 333
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • Chiang Mai, Thailand, 50200
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • GSK Investigational Site
    • Tucson, Arizona, United States, 85712
      • GSK Investigational Site
  • California
    • Burbank, California, United States, 91506
      • GSK Investigational Site
    • Los Angeles, California, United States, 90057
      • GSK Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 83686
      • GSK Investigational Site
    • Nampa, Idaho, United States, 83702
      • GSK Investigational Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • Slidell, Louisiana, United States, 70458
      • GSK Investigational Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • GSK Investigational Site
    • Saginaw, Michigan, United States, 48604
      • GSK Investigational Site
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87107
      • GSK Investigational Site
  • Ohio
    • Englewood, Ohio, United States, 45322
      • GSK Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • GSK Investigational Site
  • Tennessee
    • Hendersonville, Tennessee, United States, 29708
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77008
      • GSK Investigational Site
    • Keller, Texas, United States, 76012
      • GSK Investigational Site
    • Keller, Texas, United States, 76028
      • GSK Investigational Site
    • Keller, Texas, United States, 76051
      • GSK Investigational Site
    • Lampasas, Texas, United States, 76550
      • GSK Investigational Site
    • Plano, Texas, United States, 75093
      • GSK Investigational Site
    • Weatherford, Texas, United States, 76086
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 68701
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Biological: RSVPreF3 vaccine; No intervention was 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.
Other: 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.	Other: Control; No intervention was 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).
No Intervention: RSV MAT Group - Infant; This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother.
No Intervention: Control Group - Infant; This group consisted of infants live-born to maternal participants in the Control Group - Mother.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	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	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.	From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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; molar pregnancy; stillbirth with congenital anomaly and stillbirth with no apparent congenital anomaly. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, pregnancy outcomes were calculated based on the number of pregnancies observed from the maternal participants.	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	Assessed pregnancy-related AESIs were preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, gestational diabetes mellitus, gestational hypertension, pre-eclampsia with severe features including eclampsia, pre-eclampsia, fetal growth restriction and chorioamnionitis. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, pregnancy-related AESIs were calculated based on the number of pregnancies observed from the maternal participants.	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	Assessed AESIs were congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, low birth weight (>=1500 G and <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.	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	The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. The below presented data is read as follows: Yes = the respective risk factor was experienced by the maternal participant in the past and/or during pregnancy. No = the respective risk factor was not experienced by the maternal participant in the past and/or during pregnancy. With preterm birth event = the assessed pregnancy resulted in a preterm birth event. Without preterm birth event = the assessed pregnancy did not result in a preterm birth event. As pre-specified in the SAP, preterm birth event data stratified by selected risk factors was calculated based on the number of pregnancies observed from the maternal participants.	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	The age groups at vaccination assessed were <18 years, 18-24 years, 25-34 years and >=35 years. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by age group at vaccination was calculated based on the number of pregnancies observed from the maternal participants.	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	The pre-pregnancy body mass index (BMI) categories assessed were < 30 kilogram per square meter (kg/m^2), >=30 kg/m^2 and missing (no pre-pregnancy BMI data available). Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by pre-pregnancy BMI was calculated based on the number of pregnancies observed from the maternal participants.	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	The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by race was calculated based on the number of pregnancies observed from the maternal participants.	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	The multiple gestation pregnancies assessed were one gestation, two gestations and three gestations. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by multiple gestation pregnancy was calculated based on the number of pregnancies observed from the maternal participants.	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	The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa. Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by geographic region was calculated based on the number of pregnancies observed from the maternal participants.	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	The economic regions assessed were low and middle-income countries (LMIC) and high-income countries (HIC). Due to the character limit, further description is added here instead of Analysis population description field: As pre-specified in the SAP, preterm birth event data stratified by economic region was calculated based on the number of pregnancies observed from the maternal participants.	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	The selected risk factors assessed were prior preterm delivery, pregnancy complications, gestational diabetes mellitus, chorioamnionitis during pregnancy, hypertensive disorders of pregnancy, pre-existing hypertension, pre-existing diabetes, vaginal bleeding during pregnancy, polyhydramnios or oligohydramnios during pregnancy and fetal growth restriction. The below presented data is read as follows: Yes = the respective risk factor was experienced by the maternal participant in the past and/or during pregnancy. No = the respective risk factor was not experienced by the maternal participant in the past and/or during pregnancy. With preterm birth event = the assessed pregnancy resulted in a preterm birth event. Without preterm birth event = the assessed pregnancy did not result in a preterm birth event.	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	The age groups at vaccination assessed were <18 years, 18-24 years, 25-34 years and >=35 years.	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	The pre-pregnancy BMI categories assessed were < 30 kilogram per square meter (kg/m^2), >=30 kg/m^2 and missing (no pre-pregnancy BMI data available).	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	The races assessed were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, Multiple, Not reported and Unknown.	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	The multiple gestation pregnancies assessed were one gestation and two gestations.	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	The geographic regions assessed were Europe, Australasia, North America, Latin America and Africa.	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	The economic regions assessed were LMIC and HIC.	From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Pregnancy; Follow-up study; RSVPreF3 vaccine; Retrospective data; Prospective data
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 219510; 2022-003124-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No