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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003124-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVPreF3 vaccine | Biological | 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. |
| 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. |
| 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. |
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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:
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:
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mobile | Alabama | 36608 | United States | ||
| GSK Investigational Site |
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/
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.
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.
Of the 475 maternal participants included in the Maternal FAS, only those maternal participants who conceived within 2 years post-vaccination in prior RSV MAT studies (448) and 411 infants born to these maternal participants were considered for all analyses in this study.
A total of 3855 participants (3398 maternal participants and 457 infants) completed the informed consent process, of which 475 maternal participants with pregnancy conceived within and beyond 2 years post-vaccination in prior RSV MAT studies and 438 infants born those maternal participants with post-birth data available were included in the current study's Maternal Full Analysis Set (FAS) and Infant FAS respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group - Mother |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2023 | Jan 15, 2026 |
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| Control | Other | 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). |
|
| From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
| 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 |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| GSK Investigational Site | Tucson | Arizona | 85712 | United States |
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| GSK Investigational Site | Surrey | British Columbia | V3S 2N6 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2T1 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3K 6R8 | Canada |
| GSK Investigational Site | Truro | Nova Scotia | B2N 1L2 | Canada |
| GSK Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
| GSK Investigational Site | London-Ontario | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Joliette | Quebec | J6E 6A9 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3T 1C5 | Canada |
| GSK Investigational Site | Montreal | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Montreal | Quebec | J7J 2K8 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4G2 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Sherbrooke | Quebec | J1L 0H8 | Canada |
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| GSK Investigational Site | Cali Colombia | 760042 | Colombia |
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| GSK Investigational Site | Santo Domingo Este | Dominican Republic |
| GSK Investigational Site | Espoo | 02230 | Finland |
| GSK Investigational Site | Helsinki | 00100 | Finland |
| GSK Investigational Site | Helsinki | 00290 | Finland |
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| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
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| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Bron | 69500 | France |
| GSK Investigational Site | Paris | 75679 | France |
| GSK Investigational Site | Goch | 47574 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Hanover | 30159 | Germany |
| GSK Investigational Site | Mainz | 55116 | Germany |
| GSK Investigational Site | Würzburg | 97070 | Germany |
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| GSK Investigational Site | San Pedro Sula | 21101 | Honduras |
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| GSK Investigational Site | Mangalore | 575001 | India |
| GSK Investigational Site | Mysore | 570015 | India |
| GSK Investigational Site | Nagpur | 441108 | India |
| GSK Investigational Site | Pune | 411043 | India |
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| GSK Investigational Site | Madrid | 28222 | Spain |
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| GSK Investigational Site | Taichung | 40447 | Taiwan |
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| GSK Investigational Site | Taoyuan | 333 | Taiwan |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
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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. |
| FG002 | RSV MAT Group - Infant | This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother. |
| FG003 | Control Group - Infant | This group consisted of infants live-born to maternal participants in the Control Group - Mother. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | RSV MAT Group - Infant | This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother. |
| BG003 | Control Group - Infant | This group consisted of infants live-born to maternal participants in the Control Group - Mother. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Descriptive summaries of age are presented for the maternal participants (age at the time of vaccination in prior RSV MAT studies) included in the RSV MAT Group - Mother and Control Group - Mother and for the infants included in the RSV MAT Group - Infant and Control Group - Infant. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy outcomes data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Primary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy-related AESIs data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From conception until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Primary | 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. | Analysis was performed on the Full Analysis Set (first pregnancy) - Infant, which included all infant participants born to maternal participants from the first study pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with post-birth AESIs data available for the specified analysis during the specified period. | Posted | Count of Participants | Participants | From birth until Day 42 post-birth of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy outcomes data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pregnancy-related AESIs data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From conception until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis Set (any pregnancy) - Infant, which included all infant participants born to maternal participants from any study pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies and with post-birth AESIs data available for the specified analysis during the specified period. | Posted | Count of Participants | Participants | From birth until Day 42 post-birth of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by selected risk factors) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by age group) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by pre-pregnancy BMI) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by race) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by multiple gestation pregnancy) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by geographic region) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (any pregnancy) - Maternal, which included any pregnancies that had an outcome of live birth and were conceived by the maternal participants within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by economic region) data available for the specified analysis during the specified period of any pregnancy. | Posted | Count of Units | Pregnancies | From Day 1 until Day 42 post-delivery of any pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies | Pregnancies | Pregnancies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth event (stratified by selected risk factors) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by age group at vaccination) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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). | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by pre-pregnancy BMI group) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by race) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth event (stratified by multiple gestation pregnancy) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with pre-term birth event (stratified by geographic region) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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| Secondary | 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. | Analysis was performed on the Full Analysis set (first pregnancy) - Maternal, which included all maternal participants with first pregnancy that had an outcome of live birth and was conceived within 2 years post-vaccination received in prior RSV MAT studies and with preterm birth event (stratified by economic region) data available for the specified analysis during the specified period of the first pregnancy. | Posted | Count of Participants | Participants | From Day 1 until Day 42 post-delivery of the first pregnancy conceived within 2 years post-vaccination received in prior RSV MAT studies |
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Maternal groups: All-cause mortality, AESIs, and SAEs: From conception to Day 42 post-delivery of any pregnancy. Infant groups: All-cause mortality, AESIs, and SAEs: From birth to Day 42 post-birth of any pregnancy.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 296 | 60 | 296 | 145 | 296 |
| EG001 | 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. | 0 | 152 | 37 | 152 | 65 | 152 |
| EG002 | RSV MAT Group - Infant | This group consisted of infants live-born to maternal participants in the RSV MAT Group - Mother. | 1 | 275 | 39 | 275 | 76 | 275 |
| EG003 | Control Group - Infant | This group consisted of infants live-born to maternal participants in the Control Group - Mother. | 0 | 136 | 17 | 136 | 42 | 136 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
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| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
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| Bradycardia foetal | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
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| Foetal heart rate deceleration abnormality | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
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| Aorta hypoplasia | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Congenital abdominal hernia | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Congenital hydronephrosis | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Congenital megaureter | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Congenital syphilis | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Constricted ear deformity | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| DiGeorge's syndrome | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Ebstein's anomaly | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Microcephaly | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Penoscrotal fusion | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Polycystic liver disease | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Polydactyly | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Tethered oral tissue | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Tuberous sclerosis complex | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
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| Death neonatal | General disorders | MedDRA v 27.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA v 27.1 | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
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| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
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| ABO incompatibility | Immune system disorders | MedDRA v 27.1 | Systematic Assessment |
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| Amniotic cavity infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Bartholin's abscess | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Enterovirus infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Genitourinary tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Neonatal pneumonia | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Puerperal pyrexia | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Sepsis neonatal | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
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| Medical observation | Investigations | MedDRA v 27.1 | Systematic Assessment |
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| Weight gain poor | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
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| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 27.1 | Systematic Assessment |
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| Encephalopathy neonatal | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
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| Paresis | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Anembryonic gestation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Asynclitic presentation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Brow presentation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Foetal disorder | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
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| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Prolonged rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Superimposed pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Term baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine hypertonus | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Neonatal asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Neonatal pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Neonatal respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Labour induction | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Medically induced preterm birth | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Antiphospholipid syndrome | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Bradycardia foetal | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Foetal heart rate deceleration abnormality | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Congenital choroid plexus cyst | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Glucose-6-phosphate dehydrogenase deficiency | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Single umbilical artery | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Tethered oral tissue | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Thalassaemia alpha | Congenital, familial and genetic disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Thyroid dysfunction in pregnancy | Endocrine disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dyschezia | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Palatal oedema | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vomiting projectile | Gastrointestinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Disturbance of thermoregulation of newborn | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Macrosomia | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Cholestasis of pregnancy | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia neonatal | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| ABO incompatibility | Immune system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Rhesus incompatibility | Immune system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abscess oral | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Amniotic cavity infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Bacterial disease carrier | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Bacterial vulvovaginitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Genital herpes | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Gonorrhoea | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Obstetric infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Puerperal pyrexia | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v 27.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Electric shock | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Genital injury | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Perineal injury | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA v 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Foetal heart rate indeterminate | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Streptococcus test positive | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Poor feeding infant | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Axillary mass | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Ligament pain | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 27.1 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 27.1 | Systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Abnormal cord insertion | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Afterbirth pain | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Caput succedaneum | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Complication of delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Delayed delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Foetal malpresentation | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Gestational hyperthyroidism | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Labour pain | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Maternal pre-pregnancy obesity | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Morning sickness | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Prolonged rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Shoulder dystocia | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine atony | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | MedDRA v 27.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Fear of pregnancy | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Perinatal depression | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Postpartum anxiety | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Genital ulceration | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pelvic organ prolapse | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Shortened cervix | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Uterine pain | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Varicose veins vulval | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Irregular breathing | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Neonatal respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Caesarean section | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Female sterilisation | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Medically induced preterm birth | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Salpingectomy | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Sterilisation | Surgical and medical procedures | MedDRA v 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v 27.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v 27.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2025 | Jan 15, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| <18 years of age |
|
| 18 to 24 years of age |
|
| 25 to 34 years of age |
|
| >=35 years of age |
|
| Male |
|
| Asian |
|
| Black Or African American |
|
| Multiple |
|
| Native Hawaiian Or Other Pacific Islander |
|
| Not Reported |
|
| Unknown, Not Specified |
|
| White |
|
| Ectopic pregnancy |
|
| Elective termination with no apparent congenital anomaly |
|
| Live infant with congenital anomaly |
|
| Stillbirth with congenital anomaly |
|
| OG001 | 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. |
|
|
|
|
| OG001 |
| 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. |
|
|
| 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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. |
| OG001 | 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. |
|
|
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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
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. |
|
|
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. |
|
|
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.
| OG001 | 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. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|
| No: With preterm birth event |
|
| No: Without preterm birth event |
|