Respiratory Syncytial Virus Infections
Conditions
Keywords
Pregnancy, RSVPreF3 vaccine, Safety, Follow-up study, Retrospective data, Prospective data
Brief summary
The purpose of this follow-up study was to describe the safety in subsequent pregnancies in participants who were previously administered the RSVPreF3 maternal vaccine or control during any prior RSV MAT study. 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.
Interventions
BIOLOGICALRSVPreF3 vaccine
No intervention was administered in this extension study. Participants received the RSVPreF3 vaccine during the prior RSV MAT studies (RSV MAT-001, RSV MAT-004, RSV MAT-010, RSV MAT-011, RSV MAT-009, RSV MAT-012 and RSV MAT-039) according to the vaccination schedule specific to each study. In all prior RSV MAT studies, participants received one dose of RSVPreF3 vaccine except in RSV MAT-011 study, where some participants received a second dose as well.
OTHERControl
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).
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Retrospective cohort Adult/Adolescent Participant: * Adult/Adolescent study participant from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine). * Study participant: * who has reached 2 years+2 months post vaccine/control prior to/at enrolment or * who has not reached 2 years+2 months post vaccine/control prior to/at enrolment but is a Woman of Nonchildbearing Potential (WONCBP) at study enrolment, or recipient of bilateral tubal ligation prior to study enrolment. * Study participant with any pregnancy conceived post vaccination/control, that has reached Day 42 post-delivery prior to/at enrollment. * Provide signed and dated informed consent form. * Be willing to comply with all study requirements and be available for the duration of the study. Infant Participant: * Participant live born as the result of a pregnancy followed in an adult/adolescent participant in this study. * Signed and dated informed consent form obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure. Prospective cohort Adult/Adolescent Participant: * Adult/adolescent study participant from any of the prior RSV MAT studies who have either received RSV MAT vaccine or control (placebo, Tdap or influenza vaccine). * Study participant: * who has not reached 2 years+2 months post vaccine/control prior to/at enrollment or * who has reached at least 2 years+2 months post vaccine/control but has an ongoing pregnancy (prior to Day 42 post-delivery) at enrollment. Participants who have reached 2 years post-vaccine/control before enrollment but are pregnant at enrollment will be enrolled and followed until Day 42 post-delivery for the pregnancy ongoing at enrollment. * Female participants of childbearing potential. * Provide signed and dated informed consent form. * Be willing to comply with all study procedures and be available for the duration of the study. Infant Participant: * Participant live born as the result of a pregnancy followed in an adolescent/adult participant in this study. * Participant's parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol. * Signed and dated informed consent form obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure.
Exclusion criteria
Adult/adolescent participant otherwise eligible for the prospective cohort: • Woman of Nonchildbearing Potential (WONCBP) at study enrollment, or recipient of bilateral tubal ligation prior to study enrollment, if she has not conceived a pregnancy post-vaccine/control and does not plan to use any additional measures to attempt to conceive a pregnancy (e.g., sterilization reversal or IVF). Infant participant: • Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From conception until Day 42 post-delivery of any 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; 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. |
| 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 | From conception until Day 42 post-delivery of any pregnancy conceived 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. |
| 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 | 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. |
| 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 | From Day 1 until Day 42 post-delivery of any 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. 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. |
| 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 | From Day 1 until Day 42 post-delivery of any 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. 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. |
| 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 | From Day 1 until Day 42 post-delivery of any pregnancy conceived 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. |
| 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 | From Day 1 until Day 42 post-delivery of any 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. 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. |
| 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 | From Day 1 until Day 42 post-delivery of any pregnancy conceived 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. |
| 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 | From Day 1 until Day 42 post-delivery of any 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. 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. |
| 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 | From Day 1 until Day 42 post-delivery of any pregnancy conceived 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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). |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican Republic, Finland, France, Germany, Honduras, India, Italy, New Zealand, Panama, Philippines, South Africa, South Korea, Spain, Taiwan, Thailand, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 0 to 1 years of age | 411 Participants |
| Age, Customized 18 to 24 years of age | 0 Participants |
| Age, Customized <18 years of age | 2 Participants |
| Age, Customized 25 to 34 years of age | 0 Participants |
| Age, Customized >=35 years of age | 0 Participants |
| Race/Ethnicity, Customized American Indian Or Alaska Native | 6 Participants |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Black Or African American | 9 Participants |
| Race/Ethnicity, Customized Multiple | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Not Reported | 7 Participants |
| Race/Ethnicity, Customized Unknown, Not Specified | 4 Participants |
| Race/Ethnicity, Customized White | 179 Participants |
| Sex: Female, Male Female | 657 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 296 | 0 / 152 | 1 / 275 | 0 / 136 |
| other Total, other adverse events | 145 / 296 | 65 / 152 | 76 / 275 | 42 / 136 |
| serious Total, serious adverse events | 60 / 296 | 37 / 152 | 39 / 275 | 17 / 136 |
Outcome results
None listed