Respiratory Syncytial Virus InfectionsPhase 3NCT05705440
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 3 study testing RSVPreF3 vaccine in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 138 sites in 23 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSVPreF3 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,855 participants
- Where
- 138 sitesin 23 countries
- Study dates
- 7 Feb 2023to 15 Jan 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Show all 25Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
138 sites in 23 countries.
138 sites in 23 countries
United States27 sites
GSK Investigational Site
Albuquerque, New Mexico, 87107
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Biloxi, Mississippi, 39531
GSK Investigational Site
Burbank, California, 91506
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Detroit, Michigan, 48201
GSK Investigational Site
Englewood, Ohio, 45322
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Greenville, South Carolina, 29607
GSK Investigational Site
Hendersonville, Tennessee, 29708
GSK Investigational Site
Houston, Texas, 77008
GSK Investigational Site
Keller, Texas, 76012
GSK Investigational Site
Keller, Texas, 76028
GSK Investigational Site
Keller, Texas, 76051
GSK Investigational Site
Lampasas, Texas, 76550
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Nampa, Idaho, 83702
GSK Investigational Site
Norfolk, Virginia, 68701
GSK Investigational Site
Phoenix, Arizona, 85015
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Saginaw, Michigan, 48604
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Slidell, Louisiana, 70458
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Weatherford, Texas, 76086
Spain23 sites
GSK Investigational Site
Aravaca, 28023
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Bilbao, 48013
GSK Investigational Site
Boadilla Del Monte Madrid, 28660
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Getafe, 28905
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28041
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28222
GSK Investigational Site
Madrid, 28400
GSK Investigational Site
Málaga, 29004
GSK Investigational Site
Marbella, 29603
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Seville, 41014
GSK Investigational Site
TorrejOn Ardoz Madrid, 28850
GSK Investigational Site
Valencia, 46017
GSK Investigational Site
Valencia, 46020
GSK Investigational Site
Valencia, 46702
GSK Investigational Site
Valladolid, 47012
Canada15 sites
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Joliette, Quebec, J6E 6A9
GSK Investigational Site
Kingston, Ontario, K7L 2V7
GSK Investigational Site
London-Ontario, Ontario, N5W 6A2
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Montreal, Quebec, H9R 4S3
GSK Investigational Site
Montreal, Quebec, J7J 2K8
GSK Investigational Site
Québec, Quebec, G1V 4G2
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Sherbrooke, Quebec, J1L 0H8
GSK Investigational Site
Surrey, British Columbia, V3S 2N6
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2
GSK Investigational Site
Vancouver, British Columbia, V6Z 2T1
Finland11 sites
GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00290
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
India6 sites
GSK Investigational Site
Kolkata, 700017
GSK Investigational Site
Mangalore, 575001
GSK Investigational Site
Mysore, 570015
GSK Investigational Site
Nagpur, 441108
GSK Investigational Site
Pune, 411043
GSK Investigational Site
Vadu Budruk Pune, 412216
Brazil5 sites
GSK Investigational Site
Nova Iguaçu, 26030-380
GSK Investigational Site
Porto Alegre, 90035001
GSK Investigational Site
RibeirAo PretoSP, 14051-140
GSK Investigational Site
Santa Maria, 97105-900
GSK Investigational Site
São José do Rio Preto, 15090-000
Germany5 sites
GSK Investigational Site
Goch, 47574
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hanover, 30159
GSK Investigational Site
Mainz, 55116
GSK Investigational Site
Würzburg, 97070
Colombia4 sites
GSK Investigational Site
Barranquilla, 760002
GSK Investigational Site
Cali Colombia, 760042
GSK Investigational Site
Chía, 250001
GSK Investigational Site
Medellín, 050034
Italy4 sites
GSK Investigational Site
Bari, 70124
GSK Investigational Site
Messina, 98124
GSK Investigational Site
Milan, 20154
GSK Investigational Site
Prato, 59100
Panama4 sites
GSK Investigational Site
Panama City, 07079
GSK Investigational Site
Panama City, 0801
GSK Investigational Site
Panama City, 1001
GSK Investigational Site
Panama City, 7099
South Africa4 sites
GSK Investigational Site
Johannesburg, 2112
GSK Investigational Site
Pretoria, 0184
GSK Investigational Site
Soshanguve, 0152
GSK Investigational Site
Soweto Gauteng, 2013
Taiwan4 sites
GSK Investigational Site
Taichung, 40447
GSK Investigational Site
Taipei, 0105
GSK Investigational Site
Taipei, 10041
GSK Investigational Site
Taoyuan, 333
Australia3 sites
GSK Investigational Site
Clayton, Victoria, 3168
GSK Investigational Site
South Brisbane, Queensland, 4101
GSK Investigational Site
Southport, Queensland, 4215
Belgium3 sites
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Sint-Niklaas, 9100
France3 sites
GSK Investigational Site
Bordeaux, 33000
GSK Investigational Site
Bron, 69500
GSK Investigational Site
Paris, 75679
New Zealand3 sites
GSK Investigational Site
Grafton Auckland, 1010
GSK Investigational Site
Papatoetoe Auckland, 1701
GSK Investigational Site
Wellington, 6002
South Korea3 sites
GSK Investigational Site
Ansan, 425-707
GSK Investigational Site
Seoul, 08308
GSK Investigational Site
Seoul
Argentina2 sites
GSK Investigational Site
Buenos Aires, 1425
GSK Investigational Site
Córdoba, 5800
Bangladesh2 sites
GSK Investigational Site
Matlab
GSK Investigational Site
Sylhet, 3100
Honduras2 sites
GSK Investigational Site
Comayagua
GSK Investigational Site
San Pedro Sula, 21101
Philippines2 sites
GSK Investigational Site
Manila, 1000
GSK Investigational Site
Manila, 1008
Thailand2 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Chiang Mai, 50200
Dominican Republic1 site
GSK Investigational Site
Santo Domingo Este
About this study
Official title: 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSVPreF3 vaccine, Control
- Keywords
- Pregnancy, RSVPreF3 vaccine, Safety, Follow-up study, Retrospective data, Prospective data
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVPreF3 vaccineBiological
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.
ControlOther
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).
| Study group | Role | What they receive |
|---|---|---|
| RSV MAT Group - Mother | Other | 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. Receives: Biological: RSVPreF3 vaccine |
| Control Group - Mother | Other | 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. Receives: Other: Control |
| RSV MAT Group - Infant | No intervention | This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother. |
| Control Group - Infant | No intervention | This group consisted of infants live-born to maternal participants in the Control Group - Mother. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start7 Feb 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,855 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705440
- Sponsor's protocol ID
- 219510
- Other IDs
- 2022-003124-41
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2023
- Last updated
- 17 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/