Respiratory Syncytial Virus Infections
Conditions
Brief summary
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study also evaluated the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. 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
One dose of RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm at Day 1.
DRUGPlacebo
One dose of placebo (lyophilized sucrose reconstituted with NaCl solution) administered intramuscularly in the non-dominant arm at Day 1.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Following the decision to stop enrollment and vaccination, the study/site staff and maternal participants no longer stayed blinded.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Maternal participants * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements. * Age 18 to 49 years, inclusive, at the time of study intervention. * Pre-pregnancy BMI 17.0 to 39.9 kg/m2, inclusive. * In good general maternal health as established by medical history and clinical examination before entering into the study. * Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome). * At 24\^0/7 to 34\^0/7 weeks of gestation at the time of study vaccination (Visit 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. * 1st or 2nd 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. * No fetal genetic abnormalities (based on genetic testing, if performed). * No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation. * Willing to provide cord blood. * Who do not plan to give their child for adoption. * Who plan to reside in the study area for at least one year after delivery. * Willing to have the infant followed-up after delivery for a period of 12 months. 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 study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.
Exclusion criteria
Maternal participants Medical conditions * History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine * Hypersensitivity to latex * Significant complications in the current pregnancy: * Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (\<140mmHg and \<90mmHg) through diet and/or antihypertensive medications * Gestational diabetes not controlled by medication, diet and/or exercise * Pre-eclampsia * Eclampsia * Intrauterine Growth Restriction/Fetal Growth Restriction * Placenta previa * Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation * Polyhydramnios * Oligohydramnios * Preterm labour or history of preterm labour in the current pregnancy * Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation * Cholestasis * Other pregnancy-related complications (per investigator's judgement) * Significant structural abnormalities of the uterus or cervix * History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions * Known HIV infection (as per serological tests performed during the current pregnancy) * Known or suspected HBV or HCV infection * Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex * Active infection with tuberculosis * Known or suspected impairment of the immune system * Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery * Lymphoproliferative disorder or malignancy within 5 years before study vaccination * Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study * Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care * Any condition which would increase the risks of study participation to the unborn infant Prior/Concomitant therapy * Prior receipt of an RSV vaccine in the current pregnancy * Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period : * For a drug, vaccine or medical device: from 29 days before the dose of study vaccine * For immunoglobulins: 3 months before the dose of study vaccine/product. The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery * Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except: * Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens, Hepatitis B vaccines, and COVID-19 vaccines all of which may be administered according to standard of care ≥15 days before or after study vaccination * Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery * Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to: * Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies * Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed * Corticosteroids administered for fetal lung maturation Prior/Concurrent clinical study experience \- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product Other exclusions * Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria * A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity * Consanguinity of maternal participant and her partner (second degree cousins or closer) * Any study personnel or their immediate dependants, family or household members Infant participants * Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product * Any condition which would increase the risks of study participation to the infant * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was 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 met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | From birth to Day 121 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | The number of infant participants with all-cause pneumonia is presented in this outcome measure. |
| Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery | From study intervention administration (Day 1) to Day 181 post-delivery | RSV-associated MA-RTI is defined as a medically attended visit for RTI symptoms and confirmed RSV infection. |
| RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | At Day 1 (before study intervention administration), at Day 31 and at delivery | RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs). |
| RSV-A Neutralizing Antibody 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). |
| RSV-A Neutralizing Antibody 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 Antibody 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 Antibody 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 MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery | At delivery | 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). |
| Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations | At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained) | The placental transfer ratio of RSV-MAT IgG-specific antibody concentration was determined from cord blood over that of the blood sample from mother at delivery. If no cord blood could be obtained, an infant blood sample was collected 72 hours after birth. |
| Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | From Day 1 to Day 7 included | Assessed solicited administration site events included erythema, pain and swelling at the injection site. 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. |
| Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | 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. |
| Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included | From Day 1 to Day 30 included | An unsolicited AE is 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. |
| Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery | From Day 1 to Day 181 post-delivery | An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination. |
| Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery | From Day 1 to Day 181 post-delivery | A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination. |
| Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery | From Day 1 to Day 181 post-delivery | All-cause MA-RTI occurred when the maternal participant visited a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing. At least one all-cause MA-RTI = occurrence of at least one all-cause MA-RTI regardless of intensity grade or relation to vaccination. |
| Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery | From Day 1 to Day 42 post-delivery, an average of 2 months | An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination. |
| Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | From Day 1 to Day 42 post-delivery, an average of 2 months | Assessed pregnancy outcomes included live birth with no congenital anomalies, live birth with minor congenital anomaly(ies), live birth with at least 1 major congenital anomaly, fetal death/still birth with no congenital anomalies, fetal death/still birth with at least 1 major congenital anomaly and unknown outcome (includes participants withdrawn before/at delivery with no available data of pregnancy outcomes). |
| Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | From Day 1 to Day 42 post-delivery, an average of 2 months | Pregnancy-related AESIs included chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, maternal death, premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth. |
| Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | From birth to Day 42 post-birth, an average of 2 months | Neonatal/infant AESIs included congenital anomalies with functional defects, congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, extremely low birth weight (\<1000 grams), low birth weight (\<2500 grams), very low birth weight (\<1500 grams), neonatal death in a preterm live birth (gestational age \>=28 and \<37 weeks), neonatal death in a term live birth (\>=37 weeks of gestational age), neonatal death in an extremely pre-term birth (gestational age \>=22 and \<28 weeks), preterm birth (\<37 weeks of gestational age), small for gestational age. |
| 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 (only if no cord blood sample could be obtained at delivery) | 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 (only if no cord blood sample could be obtained at delivery). |
| Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. |
| Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider. |
| Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth | From birth to Day 366 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. |
| Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. |
| Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | From birth to Day 181 post-birth | An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B. |
Countries
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican Republic, Finland, France, Honduras, India, Italy, Mexico, New Zealand, Panama, Philippines, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 11194 participants (5959 maternal participants and 5235 infants) completed the informed consent process, of which 5328 maternal participants were exposed to the study intervention, and 5235 infants were born to those exposed mothers (RSV MAT Group - Mother and Placebo Group - Mother). Therefore, 10563 participants started the study.
Participants by arm
| Arm | Count |
|---|---|
| RSV MAT Group - Mother Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study. | 3,557 |
| Placebo Group - Mother Maternal participants received a single dose of placebo administered at Day 1 in this study. | 1,771 |
| 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. | 3,494 |
| Placebo Group - Infant This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy. | 1,741 |
| Total | 10,563 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 3 | 21 | 4 |
| Overall Study | Lost to Follow-up | 74 | 45 | 119 | 80 |
| Overall Study | Migrated / moved from the study area | 32 | 22 | 41 | 21 |
| Overall Study | Other | 1 | 2 | 7 | 3 |
| Overall Study | Protocol Violation | 4 | 5 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 66 | 37 | 68 | 50 |
Baseline characteristics
| Characteristic | RSV MAT Group - Mother | Placebo Group - Mother | RSV MAT Group - Infant | Placebo Group - Infant | Total |
|---|---|---|---|---|---|
| Age, Customized 0 to 1 years of age | 0 Participants | 0 Participants | 3494 Participants | 1741 Participants | 5235 Participants |
| Age, Customized 18 to 34 years of age | 2866 Participants | 1408 Participants | 0 Participants | 0 Participants | 4274 Participants |
| Age, Customized 35 to 39 years of age | 581 Participants | 300 Participants | 0 Participants | 0 Participants | 881 Participants |
| Age, Customized 40 to 49 years of age | 110 Participants | 63 Participants | 0 Participants | 0 Participants | 173 Participants |
| Race/Ethnicity, Customized ASIAN | 663 Participants | 326 Participants | 641 Participants | 321 Participants | 1951 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 517 Participants | 251 Participants | 463 Participants | 234 Participants | 1465 Participants |
| Race/Ethnicity, Customized OTHER, DEIDENTIFIED | 23 Participants | 11 Participants | 26 Participants | 22 Participants | 82 Participants |
| Race/Ethnicity, Customized OTHER, UNSPECIFIED | 685 Participants | 345 Participants | 730 Participants | 348 Participants | 2108 Participants |
| Race/Ethnicity, Customized WHITE | 1669 Participants | 838 Participants | 1634 Participants | 816 Participants | 4957 Participants |
| Sex/Gender, Customized Female | 3557 Participants | 1771 Participants | 1739 Participants | 867 Participants | 7934 Participants |
| Sex/Gender, Customized Male | 0 Participants | 0 Participants | 1753 Participants | 873 Participants | 2626 Participants |
| Sex/Gender, Customized Other, Unspecified | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 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 | 2 / 3,557 | 1 / 1,771 | 20 / 3,494 | 4 / 1,741 |
| other Total, other adverse events | 2,561 / 3,557 | 1,175 / 1,771 | 2,615 / 3,494 | 1,293 / 1,741 |
| serious Total, serious adverse events | 827 / 3,557 | 395 / 1,771 | 731 / 3,494 | 371 / 1,741 |
Outcome results
Primary
Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | 19 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth | 4 Participants |
Primary
Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the 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 - Infant | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | 21 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth | 4 Participants |
Primary
Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth
An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the 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 - Infant | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | 2706 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth | 1330 Participants |
Primary
Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth
An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | 2321 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth | 1135 Participants |
Primary
Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth
An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the 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 - Infant | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | 731 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth | 371 Participants |
Primary
Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth
An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Exposed Set for infants, which included the infants live-born to exposed maternal participants, whose parents/legally acceptable representative(s) (LARs) completed the informed consent process and signed the informed consent form.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | 640 Participants |
| Placebo Group - Infant | Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth | 323 Participants |
Primary
Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth
An RSV-associated LRTI of any severity was 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 met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV-associated LRTIs of any severity | 16 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV-associated severe LRTIs | 8 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV-associated LRTIs of any severity | 24 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth | RSV-associated severe LRTIs | 14 Participants |
Secondary
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations
The placental transfer ratio of RSV-MAT IgG-specific antibody concentration was determined from cord blood over that of the blood sample from mother at delivery. If no cord blood could be obtained, an infant blood sample was collected 72 hours after birth.
Time frame: At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)
Population: The analysis was performed on all pairs of maternal participants (from Per Protocol -Immunogenicity set for maternal participants) and their infants (from Per Protocol - Immunogenicity set for infants) with available results for this outcome measure at the specified time points.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV MAT Group - Infant | Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations | 1.46 Ratio |
| Placebo Group - Infant | Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations | 1.39 Ratio |
Secondary
Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth
All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | 162 Participants |
| Placebo Group - Infant | Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth | 103 Participants |
Secondary
Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth
All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 \< 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | 30 Participants |
| Placebo Group - Infant | Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth | 22 Participants |
Secondary
Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth
The number of infant participants with all-cause pneumonia is presented in this outcome measure.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | 36 Participants |
| Placebo Group - Infant | Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth | 17 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV A | 6 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV B | 10 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV A | 8 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV B | 16 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
Time frame: From birth to Day 121 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | 9 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth | 15 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth | 67 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth | 43 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants which included all the infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV A | 2 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV B | 6 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV A | 3 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth | RSV B | 11 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
Time frame: From birth to Day 121 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | 6 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth | 9 Participants |
Secondary
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 \<95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by an SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth | 38 Participants |
| Placebo Group - Infant | Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth | 22 Participants |
Secondary
Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth
Neonatal/infant AESIs included congenital anomalies with functional defects, congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, extremely low birth weight (\<1000 grams), low birth weight (\<2500 grams), very low birth weight (\<1500 grams), neonatal death in a preterm live birth (gestational age \>=28 and \<37 weeks), neonatal death in a term live birth (\>=37 weeks of gestational age), neonatal death in an extremely pre-term birth (gestational age \>=22 and \<28 weeks), preterm birth (\<37 weeks of gestational age), small for gestational age.
Time frame: From birth to Day 42 post-birth, an average of 2 months
Population: The analysis was performed on the Exposed Set for infants, 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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Major External Structural Defects | 24 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In A Preterm Live Birth (Gestational Age >=28 and <37 Weeks) | 5 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Extremely Low Birth Weight (<1000 grams) | 3 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In A Term Live Birth (>= 37 Weeks Of Gestational Age) | 6 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Internal Structural Defects | 23 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In An Extremely Pre-Term Birth (Gestational Age >=22 and <28 Weeks) | 2 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Low Birth Weight (<2500 grams) | 196 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Preterm Birth (<37 Weeks Of Gestational Age) | 237 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Functional Defects | 5 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Small For Gestational Age | 253 Participants |
| RSV MAT Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Very Low Birth Weight (<1500 grams) | 5 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Small For Gestational Age | 161 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Major External Structural Defects | 14 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Functional Defects | 2 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Congenital Anomalies With Internal Structural Defects | 16 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Extremely Low Birth Weight (<1000 grams) | 0 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Low Birth Weight (<2500 grams) | 102 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Very Low Birth Weight (<1500 grams) | 0 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In A Preterm Live Birth (Gestational Age >=28 and <37 Weeks) | 0 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In A Term Live Birth (>= 37 Weeks Of Gestational Age) | 3 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Neonatal Death In An Extremely Pre-Term Birth (Gestational Age >=22 and <28 Weeks) | 0 Participants |
| Placebo Group - Infant | Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth | Preterm Birth (<37 Weeks Of Gestational Age) | 86 Participants |
Secondary
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth
RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.
Time frame: From birth to Day 181 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | 14 Participants |
| Placebo Group - Infant | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth | 14 Participants |
Secondary
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth
RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.
Time frame: From birth to Day 366 post-birth
Population: The analysis was performed on the Modified Full Analysis - Efficacy set for infants, which included all infant participants in the Exposed Set who were born after at least 4 weeks of their maternal participants vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth | 41 Participants |
| Placebo Group - Infant | Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth | 26 Participants |
Secondary
Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included
Assessed solicited administration site events included erythema, pain and swelling at the injection site. 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: The analysis was performed on the Solicited Safety set for maternal participants, which included all maternal participants who received the study intervention and who had solicited safety data available during the specified period (i.e. from Day 1 to Day 7 included).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Erythema | 133 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Pain | 1294 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Swelling | 96 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Erythema | 8 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Pain | 230 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included | Any Swelling | 8 Participants |
Secondary
Number of Maternal Participants With 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.
Time frame: From Day 1 to Day 7 included
Population: The analysis was performed on the Solicited Safety set for maternal participants, which included all maternal participants who received the study intervention and who had solicited safety data available during the specified period (i.e. from Day 1 to Day 7 included).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Fatigue | 1091 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Nausea | 599 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Diarrhea | 351 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Fever | 26 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Headache | 942 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Vomiting | 276 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Abdominal pain | 492 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Vomiting | 149 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Abdominal pain | 231 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Diarrhea | 180 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Fatigue | 479 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Headache | 442 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Nausea | 306 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included | Any Fever | 7 Participants |
Secondary
Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included
An unsolicited AE is 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: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included | 629 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included | 297 Participants |
Secondary
Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 to Day 181 post-delivery
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery | 6 Participants |
| Placebo Group - Infant | Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery | 3 Participants |
Secondary
Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery
All-cause MA-RTI occurred when the maternal participant visited a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing. At least one all-cause MA-RTI = occurrence of at least one all-cause MA-RTI regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 to Day 181 post-delivery
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery | 317 Participants |
| Placebo Group - Infant | Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery | 144 Participants |
Secondary
Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery
An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 to Day 42 post-delivery, an average of 2 months
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery | 1717 Participants |
| Placebo Group - Infant | Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery | 785 Participants |
Secondary
Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery
An SAE is 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. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
Time frame: From Day 1 to Day 181 post-delivery
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery | 827 Participants |
| Placebo Group - Infant | Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery | 395 Participants |
Secondary
Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery
Assessed pregnancy outcomes included live birth with no congenital anomalies, live birth with minor congenital anomaly(ies), live birth with at least 1 major congenital anomaly, fetal death/still birth with no congenital anomalies, fetal death/still birth with at least 1 major congenital anomaly and unknown outcome (includes participants withdrawn before/at delivery with no available data of pregnancy outcomes).
Time frame: From Day 1 to Day 42 post-delivery, an average of 2 months
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with no congenital anomalies | 3118 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with only minor congenital anomaly(ies) | 317 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with at least 1 major congenital anomaly | 61 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Fetal death/still birth with no congenital anomalies | 9 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Fetal death/still birth with at least 1 major congenital anomaly | 2 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Unknown outcome | 50 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Fetal death/still birth with at least 1 major congenital anomaly | 0 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with no congenital anomalies | 1555 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Fetal death/still birth with no congenital anomalies | 6 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with only minor congenital anomaly(ies) | 143 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Unknown outcome | 24 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery | Live birth with at least 1 major congenital anomaly | 43 Participants |
Secondary
Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery
Pregnancy-related AESIs included chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, maternal death, premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth.
Time frame: From Day 1 to Day 42 post-delivery, an average of 2 months
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Gestational Diabetes Mellitus | 42 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Pre-Eclampsia With Severe Features Including Eclampsia | 58 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Fetal Growth Restriction | 30 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Maternal Death | 2 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Gestational Hypertension | 85 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Premature Preterm Rupture Of Membranes | 53 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Chorioamnionitis | 30 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Preterm Labor | 141 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Pre-Eclampsia | 74 Participants |
| RSV MAT Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Provider-Initiated Preterm Birth | 54 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Provider-Initiated Preterm Birth | 16 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Chorioamnionitis | 14 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Fetal Growth Restriction | 26 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Gestational Diabetes Mellitus | 19 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Gestational Hypertension | 41 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Pre-Eclampsia | 36 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Pre-Eclampsia With Severe Features Including Eclampsia | 28 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Maternal Death | 1 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Premature Preterm Rupture Of Membranes | 20 Participants |
| Placebo Group - Infant | Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery | Preterm Labor | 57 Participants |
Secondary
Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery
RSV-associated MA-RTI is defined as a medically attended visit for RTI symptoms and confirmed RSV infection.
Time frame: From study intervention administration (Day 1) to Day 181 post-delivery
Population: The analysis was performed on the Exposed Set for maternal participants, which included all maternal participants who received the study intervention.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RSV MAT Group - Infant | Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery | 3 Participants |
| Placebo Group - Infant | Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery | 6 Participants |
Secondary
RSV-A Neutralizing Antibody 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: The analysis was performed on a sub-cohort from the Per Protocol - Immunogenicity set for infants, 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 - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 121 Post-birth | 682.4 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 121 Post-birth | 74.8 Titers |
Secondary
RSV-A Neutralizing Antibody 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: The analysis was performed on a sub-cohort from the Per Protocol - Immunogenicity set for infants, which included the infant participants for whom blood samples were collected for the specified analysis at Day 181 post-birth.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV MAT Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 181 Post-birth | 506.0 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 181 Post-birth | 133.7 Titers |
Secondary
RSV-A Neutralizing Antibody 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: The analysis was performed on a sub-cohort from the Per Protocol - Immunogenicity set for infants, 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 - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 43 Post-birth | 4042.1 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Day 43 Post-birth | 311.3 Titers |
Secondary
RSV-A Neutralizing Antibody 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: The analysis was performed on the Per Protocol - Immunogenicity set for infants, 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 (i.e. at delivery or within 72 hours after birth), minus those who (a) were born less than 4 weeks post- maternal participant vaccination and/ or (b) had protocol deviations that led to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV MAT Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 9466.2 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Infant Participants at Delivery or Within 72 Hours After Birth | 725.9 Titers |
Secondary
RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery
RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs).
Time frame: At Day 1 (before study intervention administration), at Day 31 and at delivery
Population: The analysis was performed on the Per Protocol - Immunogenicity set for maternal participants, which included all maternal participants who received the study intervention to which they were randomized and had post-vaccination immunogenicity data available for the specified analysis at each of the specified time points (i.e. Day 1, Day 31, delivery) minus those participants with protocol deviations that led to exclusion.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RSV MAT Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Day 1 | 637.2 Titers |
| RSV MAT Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Day 31 | 9196.9 Titers |
| RSV MAT Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Delivery | 5703.1 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Day 1 | 594.9 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Day 31 | 673.5 Titers |
| Placebo Group - Infant | RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery | Delivery | 657.7 Titers |
Secondary
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 (only if no cord blood sample could be obtained at delivery).
Time frame: At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)
Population: The analysis was performed on the Per Protocol - Immunogenicity set for infants, 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 (i.e. at delivery or within 72 hours after birth), minus those who (a) were born less than 4 weeks post-maternal participant vaccination and/ or (b) had protocol deviations that led to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV MAT Group - Infant | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth | 94365 ELU/mL |
| Placebo Group - Infant | RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth | 6610 ELU/mL |
Secondary
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery
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 delivery
Population: The analysis was performed on the Per Protocol - Immunogenicity set for maternal participants, which included all maternal participants who received the study intervention to which they were randomized and had post-vaccination immunogenicity data available for the specified analysis at the specified time point (i.e. delivery) minus those participants with protocol deviations that led to exclusion.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RSV MAT Group - Infant | RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery | 62880 ELU/mL |
| Placebo Group - Infant | RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery | 5600 ELU/mL |