Respiratory Syncytial Virus Infections
Conditions
Keywords
Respiratory Syncytial Virus Maternal vaccine, Safety, Reactogenicity, Immune response, High risk pregnant women, Teenage girls
Brief summary
The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.
Interventions
BIOLOGICALRSV MAT
Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
DRUGPlacebo
Single dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The study was unblinded to ensure the participant's safety.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Maternal participants * Participants who can and will comply with the requirements of the protocol. * Participants and LARs who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should either: * include consent for both the maternal participant's participation\* and participation of the infant after the infant's birth, or * include consent for the maternal participant's participation\* and expressed willingness to consider permitting the infant to take part after the infant's birth (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant's birth). * both mother and father should consent if local regulations / guidelines require it. * Pre-pregnancy Body Mass Index (based on participant's report) 18.5 to 39.9 kg/m\^2, inclusive. * Healthy adolescent pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention administration. OR * Pregnant women, 18 to 49 YOA, inclusive, at the time of study intervention administration with: * HIV infection AND/OR * Obstetric complications or risk factors during the current pregnancy, where the expectant management of the pregnancy is possible and without evidence of non-reassuring fetal status (only cases for which fetal heart rate can be ascertained) as follows: * Gestational diabetes, well-controlled on medications (with or without diet or exercise) * Gestational hypertension, well-controlled on diet or medications below 160/110 mmHg. * Pre-eclampsia without severe features (i.e. eclampsia, severe hypertension \[\>160/110 mmHg\], organ dysfunction, unstable or complicated by \[HELLP\] syndrome). * Fetal Growth Restriction in singleton pregnancies, with normal umbilical artery Doppler and estimated fetal weight 3 to 10th percentile for gestational age. * History of threatened preterm labor in the current pregnancy, with no cervical dilation greater than 2 cm or effacement exceeding 50%, and/or no progressive change in cervical dilation or effacement detected by serial examinations, when maternal participant is asymptomatic * Uncomplicated twin gestation. * Pregnant females at 24\^0/7 to 36\^0/7 weeks of gestation at the time of study intervention administration (Day 1), as established by: * Last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) (i.e. at or before 28 weeks of gestation). * First or second trimester U/S only, if LMP is unknown/uncertain. * Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable. The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) gestation age assessment tool * Participants who are willing to provide cord blood. * Willing to have their offspring followed-up after delivery for a period of 12 months. * Participants who do not plan to give their offspring for adoption or place the child in care. Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be enrolled if they meet all inclusion criteria and none of the
Exclusion criteria
. Infant participants * Live-born from the study pregnancy. * If required per local regulations / guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any infant study specific procedure. To comply with RTI surveillance and other protocol required procedures that begin immediately after birth: if written consent cannot be provided by the parent(s)/LAR(s) readily post-birth, verbal consent - if permitted per local regulation -- may be sought from the parent(s) / LAR(s) instead. Verbal consent should be documented in the source data by the investigator or delegate. The parent(s) / LAR(s) will provide additional, written informed consent by (or before) Visit 2-NB.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | At delivery or within 72 hours after birth | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). |
| Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery | From Day 1 up to 42 days post-delivery, an average of 2 months | An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | From Day 1 up to 42 days post-delivery, an average of 2 months | The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported. |
| Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | From Day 1 up to 42 days post-delivery, an average of 2 months | Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction. |
| Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | From Day 1 up to 42 days post-delivery, an average of 2 months | Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria: * Change in medication and/or medication dose. * Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication. |
| Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | From birth up to 42 days post-birth, an average of 2 months | Neonatal/infant AESIs included low birth weight (below \[\<\] 2500 grams), very low birth weight (\<1500 grams), extremely low birth weight (\<1000 grams), preterm birth (\<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above \[\>=\] 28 and \<37 weeks). |
| Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth | From birth up to 42 days post-birth, an average of 2 months | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. |
| RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth | At delivery or within 72 hours after birth | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). |
| Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth | From birth up to 42 days post-birth, an average of 2 months | A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. |
| Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth | From birth up to 42 days post-birth, an average of 2 months | An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth | From birth up to 180 days post-birth | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth | From birth up to 180 days post-birth | A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. |
| Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth | From birth up to 180 days post-birth | An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth | From birth up to 365 days post-birth | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth | From birth up to 365 days post-birth | A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. |
| Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth | From birth up to 365 days post-birth | An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1) | At pre-dosing (Day 1) | RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL). |
| RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery | At delivery | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. |
| RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1) | At pre-dosing (Day 1) | RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). |
| RSV-A Neutralizing Titers for Maternal Participants at Delivery | At delivery | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations | At delivery (for maternal participants) or within 72 hours after birth (for infant participants) | The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth \[if no cord blood could be obtained\]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery). |
| Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | From Day 1 to Day 7 included | Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters. |
| Percentage of Maternal Participants Reporting Any Solicited Systemic Events | From Day 1 to Day 7 included | Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever \[temperature equal to or above (\>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement\] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. |
| Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs) | From Day 1 to Day 30 included | An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery | From Day 1 up to 42 days post-delivery, an average of 2 months | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. |
| Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery | From Day 1 up to 42 days post-delivery, an average of 2 months | A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery | From Day 1 up to 180 days post-delivery | A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons. |
| Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery | From Day 1 up to 180 days post-delivery | An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | From Day 1 up to 180 days post-delivery | Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgement and the following criteria: * Change in medication and/or medication dose. * Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication. |
| Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery | From Day 1 up to 180 days post-delivery | RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection. |
| Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth | From birth up to 365 days post-birth | An RSV-associated LRTI is characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (\<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI meets the case definition of RSV-LRTI AND is additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. |
| Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth | From birth up to 365 days post-birth | RSV-associated hospitalization was defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization was defined as admission for observation or treatment based on the judgment of a health care provider. |
| RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing | At Day 31 post-dosing | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. |
| RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing | At Day 31 post-dosing | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | At pre-dosing (Day 1), Day 31 post-dosing and delivery | RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | At delivery or within 72 hours after birth | RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained). |
| RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth | At Day 43 post-birth | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. |
| RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth | At Day 121 post-birth | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. |
| RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth | At Day 181 post-birth | RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. |
| RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth | At Day 43 post-birth | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth | At Day 121 post-birth | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth | At Day 181 post-birth | RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth | At Day 43 post-birth | RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth | At Day 121 post-birth | RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth | At Day 181 post-birth | RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. |
| Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery | From Day 1 up to 180 days post-delivery | An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. |
Countries
Brazil, Canada, Finland, India, Italy, Panama, South Africa, Spain, United States
Participant flow
Pre-assignment details
Out of 384 participants who completed the informed consent process, 169 maternal participants were vaccinated, and 198 infants, including twins, were born to those exposed mothers (RSV\_MAT Group-Mother and Control Group-Mother). Therefore, 367 participants were considered exposed.
Participants by arm
| Arm | Count |
|---|---|
| RSV_MAT Group-Mother Maternal participants randomized to the RSV\_MAT Group received a single dose of the RSV MAT vaccine administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | 113 |
| Control Group-Mother Maternal participants randomized to the Control Group received a single dose of Placebo administered, between 24 and 36 weeks of gestation, at Day 1 in this study. | 56 |
| RSV_MAT Group-Infant This group consisted of infants born to mothers (from RSV\_MAT Group-Mother) who received a single dose of RSV MAT vaccine during pregnancy. | 132 |
| Control Group-Infant This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy. | 66 |
| Total | 367 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 3 | 2 | 3 |
| Overall Study | MIGRATED / MOVED FROM THE STUDY AREA | 1 | 1 | 2 | 1 |
| Overall Study | WITHDRAWAL BY SUBJECT, NOT DUE TO AN ADVERSE EVENT | 2 | 0 | 0 | 0 |
| Overall Study | WITHDRAWAL BY SUBJECT'S PARENT(S)/LAR(S) | 0 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | RSV_MAT Group-Mother | Control Group-Mother | RSV_MAT Group-Infant | Control Group-Infant | Total |
|---|---|---|---|---|---|
| Age, Customized 0 to 1 years of age | 0 Participants | 0 Participants | 132 Participants | 66 Participants | 198 Participants |
| Age, Customized 15 < 18 years of age | 13 Participants | 6 Participants | 0 Participants | 0 Participants | 19 Participants |
| Age, Customized 18 to 49 years of age | 100 Participants | 50 Participants | 0 Participants | 0 Participants | 150 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 4 Participants | 1 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 33 Participants | 18 Participants | 33 Participants | 18 Participants | 102 Participants |
| Race/Ethnicity, Customized Other, unspecified | 24 Participants | 13 Participants | 28 Participants | 13 Participants | 78 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 24 Participants | 67 Participants | 34 Participants | 177 Participants |
| Sex: Female, Male Female | 113 Participants | 56 Participants | 63 Participants | 29 Participants | 261 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 69 Participants | 37 Participants | 106 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 / 113 | 0 / 56 | 1 / 132 | 1 / 66 |
| other Total, other adverse events | 89 / 113 | 38 / 56 | 118 / 132 | 57 / 66 |
| serious Total, serious adverse events | 33 / 113 | 11 / 56 | 35 / 132 | 21 / 66 |
Outcome results
Primary
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth \[if no cord blood could be obtained\]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery).
Time frame: At delivery (for maternal participants) or within 72 hours after birth (for infant participants)
Population: Analysis was performed on all pairs of maternal participants (from Per Protocol Set Immunogenicity - Maternal) and their infants (from Per Protocol Set Immunogenicity - Infant) with available results for this outcome measure at the specified time points.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations | 1.33 Ratio |
| Control Group-Mother | Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations | 2.30 Ratio |
Primary
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Time frame: From birth up to 180 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth | 0 Participants |
| Control Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth | 0 Participants |
Primary
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Time frame: From birth up to 365 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth | 0 Participants |
| Control Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth | 0 Participants |
Primary
Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Time frame: From birth up to 42 days post-birth, an average of 2 months
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth | 0 Participants |
| Control Group-Mother | Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth | 0 Participants |
Primary
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery | 0 Participants |
| Control Group-Mother | Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery | 0 Participants |
Primary
Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Time frame: From birth up to 180 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth | 25.0 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth | 30.3 Percentage of participants |
Primary
Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Time frame: From birth up to 365 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth | 26.5 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth | 31.8 Percentage of participants |
Primary
Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Time frame: From birth up to 42 days post-birth, an average of 2 months
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth | 20.5 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth | 27.3 Percentage of participants |
Primary
Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: From birth up to 180 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth | 77.3 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth | 69.7 Percentage of participants |
Primary
Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: From birth up to 365 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth | 86.4 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth | 75.8 Percentage of participants |
Primary
Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: From birth up to 42 days post-birth, an average of 2 months
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth | 56.8 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth | 54.5 Percentage of participants |
Primary
Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth
Neonatal/infant AESIs included low birth weight (below \[\<\] 2500 grams), very low birth weight (\<1500 grams), extremely low birth weight (\<1000 grams), preterm birth (\<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above \[\>=\] 28 and \<37 weeks).
Time frame: From birth up to 42 days post-birth, an average of 2 months
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Extremely Low Birth Weight (<1000 grams) | 0 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Small For Gestational Age | 14.4 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Very Low Birth Weight (<1500 grams) | 2.3 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Congenital Anomalies With Internal Structural Defects | 3.0 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Preterm Birth (<37 Weeks Of Gestational Age) | 18.2 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Neonatal Death In A Preterm Live Birth (gestational age >=28 and <37 weeks) | 0.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Low Birth Weight (<2500 grams) | 16.7 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Neonatal Death In A Preterm Live Birth (gestational age >=28 and <37 weeks) | 1.5 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Low Birth Weight (<2500 grams) | 18.2 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Very Low Birth Weight (<1500 grams) | 1.5 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Extremely Low Birth Weight (<1000 grams) | 1.5 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Preterm Birth (<37 Weeks Of Gestational Age) | 19.7 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Small For Gestational Age | 27.3 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth | Congenital Anomalies With Internal Structural Defects | 0 Percentage of participants |
Primary
Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly
The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/legally acceptable representatives (LARs) completed the informed consent process and signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH NO CONGENITAL ANOMALIES | 86.4 Percentage of live births |
| RSV_MAT Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH ONLY MINOR CONGENITAL ANOMALY(IES) | 10.6 Percentage of live births |
| RSV_MAT Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH AT LEAST ONE MAJOR CONGENITAL ANOMALY | 3.0 Percentage of live births |
| Control Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH NO CONGENITAL ANOMALIES | 84.8 Percentage of live births |
| Control Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH ONLY MINOR CONGENITAL ANOMALY(IES) | 13.6 Percentage of live births |
| Control Group-Mother | Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly | LIVE BIRTH WITH AT LEAST ONE MAJOR CONGENITAL ANOMALY | 1.5 Percentage of live births |
Primary
Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery | 29.2 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery | 19.6 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Any Solicited Administration Site Events
Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters.
Time frame: From Day 1 to Day 7 included
Population: Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Erythema | 0.9 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Pain | 44.2 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Swelling | 0 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Erythema | 0 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Pain | 14.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Administration Site Events | Any Swelling | 1.9 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Any Solicited Systemic Events
Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever \[temperature equal to or above (\>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement\] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 to Day 7 included
Population: Analysis was performed on the Solicited Safety Set, which included all maternal participants who received 1 dose of a study intervention and who had solicited safety data available during the specified period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Abdominal pain | 20.4 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Nausea | 24.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Fatigue | 28.3 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Fever | 0 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Diarrhea | 20.4 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Vomiting | 8.0 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Headache | 39.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Vomiting | 20.4 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Abdominal pain | 16.7 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Diarrhea | 7.4 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Fatigue | 27.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Headache | 38.9 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Nausea | 20.4 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Solicited Systemic Events | Any Fever | 0 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 to Day 30 included
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs) | 34.5 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs) | 37.5 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery
An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery | 57.5 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery | 58.9 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery
Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Premature preterm rupture of membranes | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Pre-eclampsia with severe features including eclampsia | 4.4 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Provider-initiated preterm birth | 3.5 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Gestational hypertension | 0.9 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Pre-eclampsia | 4.4 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Fetal growth restriction | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Preterm labor | 8.0 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Fetal growth restriction | 3.6 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Preterm labor | 7.1 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Provider-initiated preterm birth | 5.4 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Premature preterm rupture of membranes | 5.4 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Pre-eclampsia | 3.6 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Pre-eclampsia with severe features including eclampsia | 0 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery | Gestational hypertension | 3.6 Percentage of participants |
Primary
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria: * Change in medication and/or medication dose. * Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Time frame: From Day 1 up to 42 days post-delivery, an average of 2 months
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | Change In Medication And/Or Medication Dose | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | Medically Attended Event In Relation To Pre-Existing Condition And/Or Obstetric Complication | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | SAE And/Or Hospitalization In Relation To Pre-Existing Condition And/Or Obstetric Complication | 1.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | Change In Medication And/Or Medication Dose | 1.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | Medically Attended Event In Relation To Pre-Existing Condition And/Or Obstetric Complication | 7.1 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery | SAE And/Or Hospitalization In Relation To Pre-Existing Condition And/Or Obstetric Complication | 3.6 Percentage of participants |
Primary
RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 72 hours after birth
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) have protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 9080.2 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 694.6 Titers |
Primary
RSV-A Neutralizing Titers for Maternal Participants at Delivery
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At delivery
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Delivery | 6240.3 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Delivery | 612.8 Titers |
Primary
RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1)
RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs).
Time frame: At pre-dosing (Day 1)
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing \[Day 1\]), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1) | 681.5 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1) | 752.4 Titers |
Primary
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 72 hours after birth
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth | 77625.1 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth | 9228 ELU/mL |
Primary
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Time frame: At delivery
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. delivery), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery | 70337.1 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery | 4421 ELU/mL |
Primary
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1)
RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL).
Time frame: At pre-dosing (Day 1)
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. pre-dosing \[Day 1\]), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1) | 4981.6 ELU/mL |
| Control Group-Mother | RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1) | 5981.7 ELU/mL |
Secondary
Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery
RSV-associated MA-RTI was defined as a medically attended visit for RTI symptoms and confirmed RSV infection.
Time frame: From Day 1 up to 180 days post-delivery
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery | 0 Participants |
| Control Group-Mother | Number of Maternal Participants Reporting RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTIs) From Day 1 up to 180 Days Post-delivery | 0 Participants |
Secondary
Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery
A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons.
Time frame: From Day 1 up to 180 days post-delivery
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV_MAT Group-Mother | Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery | 0 Participants |
| Control Group-Mother | Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 180 Days Post-delivery | 0 Participants |
Secondary
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth
RSV-associated hospitalization was defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization was defined as admission for observation or treatment based on the judgment of a health care provider.
Time frame: From birth up to 365 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth | 0.8 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Hospitalizations From Birth up to 365 Days Post-birth | 0 Percentage of participants |
Secondary
Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth
An RSV-associated LRTI is characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (\<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI meets the case definition of RSV-LRTI AND is additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious.
Time frame: From birth up to 365 days post-birth
Population: Analysis was performed on the Exposed Set - Infant, which included infants live-born to exposed maternal participants, whose parents/LARs completed the informed consent process and signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth | Any RSV-associated LRTIs | 0.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth | RSV-associated Severe LRTIs | 0 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth | Any RSV-associated LRTIs | 3.0 Percentage of participants |
| Control Group-Mother | Percentage of Infant Participants Reporting Medically Assessed, RSV-associated Lower Respiratory Tract Illness (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth up to 365 Days Post-birth | RSV-associated Severe LRTIs | 0 Percentage of participants |
Secondary
Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 up to 180 days post-delivery
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery | 29.2 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Any SAEs From Day 1 up to 180 Days Post-delivery | 19.6 Percentage of participants |
Secondary
Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery
An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.
Time frame: From Day 1 up to 180 days post-delivery
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery | 61.1 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting MAEs From Day 1 up to 180 Days Post-delivery | 60.7 Percentage of participants |
Secondary
Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery
Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgement and the following criteria: * Change in medication and/or medication dose. * Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication.
Time frame: From Day 1 up to 180 days post-delivery
Population: Analysis was performed on the Exposed Set - Maternal, which included all maternal participants who received 1 dose of a study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | Change In Medication And/Or Medication Dose | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | Medically Attended Event In Relation To Pre-Existing Condition And/Or Obstetric Complication | 1.8 Percentage of participants |
| RSV_MAT Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | SAE And/Or Hospitalization In Relation To Pre-Existing Condition And/Or Obstetric Complication | 1.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | Change In Medication And/Or Medication Dose | 1.8 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | Medically Attended Event In Relation To Pre-Existing Condition And/Or Obstetric Complication | 7.1 Percentage of participants |
| Control Group-Mother | Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 180 Days Post-delivery | SAE And/Or Hospitalization In Relation To Pre-Existing Condition And/Or Obstetric Complication | 3.6 Percentage of participants |
Secondary
RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 121 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth | 607.9 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 121 Post-birth | 94.1 Titers |
Secondary
RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 181 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth | 755 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 181 Post-birth | 115 Titers |
Secondary
RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 43 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth | 3203.8 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Infant Participants at Day 43 Post-birth | 240.5 Titers |
Secondary
RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing
RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 31 post-dosing
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing | 9959.7 Titers |
| Control Group-Mother | RSV-A Neutralizing Titers for Maternal Participants at Day 31 Post-dosing | 575.2 Titers |
Secondary
RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 121 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth | 622.7 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 121 Post-birth | 54.9 Titers |
Secondary
RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 181 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth | 327.9 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 181 Post-birth | 63 Titers |
Secondary
RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At Day 43 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth | 3012.8 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Day 43 Post-birth | 273.3 Titers |
Secondary
RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 72 hours after birth
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Infant, which included all infant participants in the Exposed set who had post-delivery/birth immunogenicity data available for the specified analysis at the specified time points, minus those who (a) were born less than 4 weeks post-maternal participant dosing and/ or (b) had protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 9145.5 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 779.7 Titers |
Secondary
RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery
RSV-B neutralizing titers were determined by neutralization assay and expressed as GMTs.
Time frame: At pre-dosing (Day 1), Day 31 post-dosing and delivery
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time points, minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Day 1 | 756.6 Titers |
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Day 31 | 9928.9 Titers |
| RSV_MAT Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Delivery | 6336.9 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Day 1 | 863.4 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Day 31 | 640.7 Titers |
| Control Group-Mother | RSV-B Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), Day 31 Post-dosing and Delivery | Delivery | 650.2 Titers |
Secondary
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Time frame: At Day 121 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 121 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth | 4365.1 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 121 Post-birth | 446.8 ELU/mL |
Secondary
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Time frame: At Day 181 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth. There was only one participant in the Control Group - Infant for whom blood sample was collected, hence the 95% confidence interval (CI) associated with geometric mean could not be calculated for single participant.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth | 2857.8 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 181 Post-birth | 241 ELU/mL |
Secondary
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Time frame: At Day 43 post-birth
Population: Analysis was performed on a sub-cohort from the Per Protocol Set Immunogenicity - Infant, which included the infant participants for whom blood samples were collected for the specified analysis at Day 43 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth | 29932.5 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Day 43 Post-birth | 1310 ELU/mL |
Secondary
RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing
RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL.
Time frame: At Day 31 post-dosing
Population: Analysis was performed on the Per Protocol Set Immunogenicity - Maternal, which included all maternal participants who received 1 dose of a study intervention and had immunogenicity data available for the specified analysis at the specified time point (i.e. Day 31 post-dosing), minus those participants with protocol deviations that lead to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV_MAT Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing | 113957.1 ELU/mL |
| Control Group-Mother | RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Day 31 Post-dosing | 5510.6 ELU/mL |