A Phase 2 interventional study of RSV MAT 60 µg and RSV MAT 120 µg in Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 32 sites in 9 countries. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-13.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.
293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.
This study's enrollment of 534 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.
Browse Respiratory Syncytial Virus Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Maternal subjects
Subjects 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 (consistent with local regulations / guidelines) either:
At 28\^0/7 to 33\^6/7 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).
* If LMP and U/S do not correlate, default to U/S gestational age assessment. The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunisation safety Assessment in pregnancy gestation age assessment tool
Infant subjects
Exclusion Criteria:
Maternal subjects
Medical conditions
Significant complications in the current pregnancy such as:
Prior/Concomitant therapy
Administration of immune-modifying therapy within 6 months before the study vaccine/product dose, or planned administration through delivery. This includes but is not limited to:
Prior/Concomitant clinical study experience
Other exclusions
Infant subjects
Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.
Biological: RSV MAT 60 µg
Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.
Biological: RSV MAT 120 µg
Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Drug: Placebo
This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Time frame: During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Percentage of Maternal Subjects With Any Solicited Systemic Events
Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever \[temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
Time frame: During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'WBC decrease Below (B) - Within (D8)' = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.
Time frame: At Day 8
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'AST increase Below (B) - Within (D8)' = AST increase in subjects with below normal values at baseline and within normal values at Day 8.
Time frame: At Day 8
Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Time frame: From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Pregnancy Outcomes
Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).
Time frame: From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Pregnancy-related AESIs were: Non-Reassuring Fetal Status, Hypertensive Disorders of Pregnancy (HDP), Oligohydramnios, Pathways to Preterm Birth (PPB), Chorioamnionitis, Fetal Growth Restriction, Gestational Liver Disease (GLD), Postpartum Haemorrhage and Gestational Diabetes Mellitus.
Time frame: From Day 1 to Day 43 post-delivery
Percentage of Infant Subjects With Neonatal AESIs
Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).
Time frame: From birth to Day 43 post-birth
Percentage of Infant Subjects With Any SAEs
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From birth to Day 43 post-birth
Percentage of Infant Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Time frame: From birth to Day 43 post-birth
Percentage of Infant Subjects With Any MAEs
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From birth to Day 43 post-birth
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.
Time frame: At Day 1 (before vaccination), Day 31 and at delivery
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
Time frame: At Day 1 (before vaccination), Day 31 and at delivery
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 3 days after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 3 days after birth
Geometric Mean Ratio 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 blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA.
Time frame: At delivery (for maternal subjects) or within 3 days after birth (for infants)
Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From Day 1 to Day 181 post-delivery
Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From Day 1 to Day 181 post-delivery
Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Time frame: From Day 1 to Day 181 post-delivery
Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From birth to Month 12 post-birth
Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
Time frame: From birth to Month 12 post-birth
Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Time frame: From birth to Month 12 post-birth
Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.
Time frame: From delivery to Day 181 post-delivery
Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (\<) 95% or respiratory rate increase and a confirmed RSV infection.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Severe LRTI
A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 93% or lower chest wall in-drawing and a confirmed RSV infection.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Very Severe LRTI
A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.
Time frame: From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Hospitalisation
An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
Time frame: From birth to Day 181 post-birth
RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Time frame: At Day 43 post-delivery
RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 43 post-delivery
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-delivery
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Time frame: At Day 43 after birth
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Time frame: At Day 121 after birth
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
Time frame: At Day 181 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 43 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 121 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 181 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
Time frame: At delivery or within 3 days after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 43 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 121 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
Time frame: At Day 181 after birth
| Milestone | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|---|---|---|
| Started | 70 | 75 | 68 | 67 | 73 | 66 |
| Completed | 58 | 70 | 59 | 54 | 67 | 55 |
| Not completed | 12 | 5 | 9 | 13 | 6 | 11 |
| Withdrew: Lost to follow-up | 9 | 1 | 5 | 10 | 4 | 7 |
| Withdrew: Withdrawal by subject | 3 | 2 | 1 | 1 | 1 | 1 |
| Withdrew: Other | 0 | 0 | 2 | 2 | 0 | 1 |
| Withdrew: Migrated / moved from the study area | 0 | 2 | 1 | 0 | 1 | 2 |
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Any Pain | 57.1 (44.7 to 68.9) | 52 (40.2 to 63.7) | 15.2 (7.5 to 26.1) |
| Any Erythema | 1.4 (0 to 7.7) | 6.7 (2.2 to 14.9) | 0 (0 to 5.4) |
| Any Swelling | 4.3 (0.9 to 12) | 4 (0.8 to 11.2) | 0 (0 to 5.4) |
Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever \[temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Any Fatigue | 40 (28.5 to 52.4) | 34.7 (24 to 46.5) | 25.8 (15.8 to 38) |
| Any Headache | 34.3 (23.3 to 46.6) | 28 (18.2 to 39.6) | 19.7 (10.9 to 31.3) |
| Any Nausea | 25.7 (16 to 37.6) | 22.7 (13.8 to 33.8) | 13.6 (6.4 to 24.3) |
| Any Vomiting | 7.1 (2.4 to 15.9) | 9.3 (3.8 to 18.3) | 4.5 (0.9 to 12.7) |
| Any Diarrhea | 14.3 (7.1 to 24.7) | 17.3 (9.6 to 27.8) | 13.6 (6.4 to 24.3) |
| Any Abdominal pain | 12.9 (6.1 to 23) | 22.7 (13.8 to 33.8) | 9.1 (3.4 to 18.7) |
| Any Fever | 0 (0 to 5.1) | 0 (0 to 4.8) | 0 (0 to 5.4) |
Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'WBC decrease Below (B) - Within (D8)' = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.
| Participants | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| EOS Increase Below (B)-Below (D8) | 6 | 5 | 2 |
| EOS Increase Below (B)-Within (D8) | 6 | 2 | 4 |
| EOS Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| EOS Increase Below (B)-Unknown (D8) | 0 | 0 | 1 |
| EOS Increase Within (B)-Below (D8) | 2 | 5 | 2 |
| EOS Increase Within (B)-Within (D8) | 53 | 58 | 56 |
| EOS Increase Within (B)-Above (D8) | 0 | 0 | 0 |
| EOS Increase Within (B)-Unknown (D8) | 2 | 3 | 1 |
| EOS Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| EOS Increase Above (B)-Within (D8) | 0 | 1 | 0 |
| EOS Increase Above (B)-Above (D8) | 1 | 1 | 0 |
| EOS Increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| EOS Increase Unknown(B)-Below (D8) | 0 | 0 | 0 |
| EOS Increase Unknown (B)-Within (D8) | 0 | 0 | 2 |
| EOS Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| EOS Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| ERY Decrease Below (B)-Below (D8) | 24 | 35 | 23 |
| ERY Decrease Below (B)-Within (D8) | 4 | 2 | 5 |
| ERY Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| ERY Decrease Below (B)-Unknown (D8) | 1 | 2 | 2 |
| ERY Decrease Within (B)-Below (D8) | 6 | 2 | 7 |
| ERY Decrease Within (B)-Within (D8) | 34 | 34 | 29 |
| ERY Decrease Within (B)-Above (D8) | 0 | 0 | 0 |
| ERY Decrease Within(B)-Unknown (D8) | 1 | 0 | 0 |
| ERY Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| ERY Decrease Above (B)-Within (D8) | 0 | 0 | 0 |
| ERY Decrease Above (B)-Above (D8) | 0 | 0 | 0 |
| ERY Decrease Above (B)-Unknown (D8) | 0 | 0 | 0 |
| ERY Decrease Unknown (B)-Below (D8) | 0 | 0 | 2 |
| ERY Decrease Unknown (B)-Within (D8) | 0 | 0 | 0 |
| ERY Decrease Unknown (B)-Above (D8) | 0 | 0 | 0 |
| ERY Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| ERY Increase Below (B)-Below (D8) | 24 | 35 | 23 |
| ERY Increase Below (B)-Within (D8) | 4 | 2 | 5 |
| ERY Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| ERY Increase Below (B)-Unknown (D8) | 1 | 2 | 2 |
| ERY Increase Within (B)-Below (D8) | 6 | 2 | 7 |
| ERY Increase Within (B)-Within (D8) | 34 | 34 | 29 |
| ERY Increase Within (B)-Above (D8) | 0 | 0 | 0 |
| ERY Increase Within (B)-Unknown (D8) | 1 | 0 | 0 |
| ERY Increase Above-Below (D8) | 0 | 0 | 0 |
| ERY Increase Above (B)-Within (D8) | 0 | 0 | 0 |
| ERY Increase Above (B)-Above (D8) | 0 | 0 | 0 |
| ERY Increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| ERY Increase Unknown (B)-Below (D8) | 0 | 0 | 2 |
| ERY Increase Unknown (B)-Within (D8) | 0 | 0 | 0 |
| ERY Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| ERY Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| HEM Decrease Below (B)-Below (D8) | 25 | 26 | 24 |
| HEM Decrease Below (B)-Within (D8) | 2 | 3 | 2 |
| HEM Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| HEM Decrease Below (B)-Unknown (D8) | 1 | 1 | 1 |
| HEM Decrease Within (B)-Below (D8) | 7 | 9 | 7 |
| HEM Decrease Within (B)- Within (D8) | 34 | 35 | 31 |
| HEM Decrease Within (B)-Above (D8) | 0 | 0 | 0 |
| HEM Decrease Within (B)-Unknown (D8) | 1 | 1 | 1 |
| HEM Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| HEM Decrease Above (B)-Within (D8) | 0 | 0 | 0 |
| HEM Decrease Above (B)-Above (D8) | 0 | 0 | 0 |
| HEM Decrease Above (B)-Unknown (D8) | 0 | 0 | 0 |
| HEM Decrease Unknown (B)-Below (D8) | 0 | 0 | 2 |
| HEM Decrease Unknown (B)-Within (D8) | 0 | 0 | 0 |
| HEM Decrease Unknown (B)-Above (D8) | 0 | 0 | 0 |
| HEM Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| HEM Increase Below (B)-Below (D8) | 25 | 26 | 24 |
| HEM Increase Below (B)-Within (D8) | 2 | 3 | 2 |
| HEM Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| HEM Increase Below (B)-Unknown (D8) | 1 | 1 | 1 |
| HEM Increase Within (B)-Below (D8) | 7 | 9 | 7 |
| HEM Increase Within (B)-Within (D8) | 34 | 35 | 31 |
| HEM Increase Within (B)-Above (D8) | 0 | 0 | 0 |
| HEM Increase Within (B)-Unknown (D8) | 1 | 1 | 1 |
| HEM Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| HEM Increase Above (B)-Within (D8) | 0 | 0 | 0 |
| HEM Increase Above (B)-Above (D8) | 0 | 0 | 0 |
| HEM Increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| HEM Increase Unknown (B)-Below (D8) | 0 | 0 | 2 |
| HEM Increase Unknown (B)-Within (D8) | 0 | 0 | 0 |
| HEM Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| HEM Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Decrease Below (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Decrease Below (B)-Within (D8) | 0 | 0 | 1 |
| LYMP Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Decrease Below (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Decrease Within (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Decrease Within (B)-Within (D8) | 68 | 72 | 63 |
| LYMP Decrease Within (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Decrease Within (B)-Unknown (D8) | 2 | 3 | 2 |
| LYMP Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Decrease Above (B)-Within (D8) | 0 | 0 | 0 |
| LYMP Decrease Above (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Decrease Above (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Decrease Unknown (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Decrease Unknown (B)-Within (D8) | 0 | 0 | 2 |
| LYMP Decrease Unknown (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Increase Below (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Increase Below (B)-Within (D8) | 0 | 0 | 1 |
| LYMP Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Increase Below (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Increase Within (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Increase Within (B)-Within (D8) | 68 | 72 | 63 |
| LYMP Increase Within (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Increase Within (B)-Unknown (D8) | 2 | 3 | 2 |
| LYMP Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Increase Above (B)-Within (D8) | 0 | 0 | 0 |
| LYMP Increase Above (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| LYMP Increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| LYMP Increase Unknown (B)-Within (D8) | 0 | 0 | 2 |
| LYMP Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| LYMP Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| MCV Decrease Below (B)-Below (D8) | 2 | 1 | 1 |
| MCV Decrease Below (B)-Within (D8) | 0 | 0 | 0 |
| MCV Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| MCV Decrease Below (B)-Unknown (D8) | 0 | 0 | 0 |
| MCV Decrease Within (B)-Below (D8) | 0 | 0 | 1 |
| MCV Decrease Within (B)-Within (D8) | 62 | 66 | 57 |
| MCV Decrease Within (B)-Above (D8) | 2 | 2 | 1 |
| MCV Decrease Within (B)-Unknown (D8) | 2 | 1 | 2 |
| MCV Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| MCV Decrease Above (B)-Within (D8) | 0 | 2 | 1 |
| MCV Decrease Above (B)-Above (D8) | 2 | 2 | 3 |
| MCV Decrease Above (B)-Unknown (D8) | 0 | 1 | 0 |
| MCV Decrease Unknown (B)-Below (D8) | 0 | 0 | 0 |
| MCV Decrease Unknown (B)-Within (D8) | 0 | 0 | 2 |
| MCV Decrease Unknown (B)-Above (D8) | 0 | 0 | 0 |
| MCV Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| MCV Increase Below (B)-Below (D8) | 2 | 1 | 1 |
| MCV Increase Below (B)-Within (D8) | 0 | 0 | 0 |
| MCV Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| MCV Increase Below (B)- Unknown (D8) | 0 | 0 | 0 |
| MCV Increase Within (B)-Below (D8) | 0 | 0 | 1 |
| MCV Increase Within (B)-Within (D8) | 62 | 66 | 57 |
| MCV Increase Within (B)-Above (D8) | 2 | 2 | 1 |
| MCV Increase Within (B)-Unknown (D8) | 2 | 1 | 2 |
| MCV Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| MCV Increase Above (B)-Within (D8) | 0 | 2 | 1 |
| MCV Increase Above (B)-Above (D8) | 2 | 2 | 3 |
| MCV Increase Above (B)-Unknown (D8) | 0 | 1 | 0 |
| MCV Increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| MCV Increase Unknown (B)-Within (D8) | 0 | 0 | 2 |
| MCV Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| MCV Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| NEU Decrease Below (B)-Below (D8) | 0 | 0 | 0 |
| NEU Decrease Below (B)-Within (D8) | 0 | 0 | 0 |
| NEU Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| NEU Decrease Below (B)-Unknown (D8) | 0 | 0 | 0 |
| NEU Decrease Within (B)-Below (D8) | 0 | 0 | 0 |
| NEU Decrease Within (B)-Within (D8) | 42 | 46 | 41 |
| NEU Decrease Within (B)-Above (D8) | 8 | 9 | 9 |
| NEU Decrease Within (B)-Unknown (D8) | 0 | 2 | 1 |
| NEU Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| NEU Decrease Above (B)-Within (D8) | 5 | 5 | 6 |
| NEU Decrease Above (B)-Above (D8) | 13 | 12 | 8 |
| NEU Decrease Above (B)-Unknown (D8) | 2 | 1 | 1 |
| NEU Decrease Unknown (B)-Below (D8) | 0 | 0 | 0 |
| NEU Decrease Unknown (B)-Within (D8) | 0 | 0 | 1 |
| NEU Decrease Unknown (B)-Above (D8) | 0 | 0 | 1 |
| NEU Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Decrease Below (B)-Below (D8) | 0 | 0 | 0 |
| PLA Decrease Below (B)-Within (D8) | 1 | 1 | 0 |
| PLA Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| PLA Decrease Below (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Decrease Within (B)-Below (D8) | 0 | 0 | 0 |
| PLA Decrease Within (B)-Within (D8) | 67 | 72 | 63 |
| PLA Decrease Within (B)-Above (D8) | 0 | 0 | 0 |
| PLA Decrease Within (B)-Unknown (D8) | 2 | 2 | 2 |
| PLA Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| PLA Decrease Above (B)-Within (D8) | 0 | 0 | 1 |
| PLA Decrease Above (B)- Above (D8) | 0 | 0 | 0 |
| PLA Decrease Above (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Decrease Unknown (B)-Below (D8) | 0 | 0 | 0 |
| PLA Decrease Unknown (B)-Within (D8) | 0 | 0 | 2 |
| PLA Decrease Unknown (B)-Above (D8) | 0 | 0 | 0 |
| PLA Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Increase Below (B)-Below (D8) | 0 | 0 | 0 |
| PLA Increase Below (B)-Within (D8) | 1 | 1 | 0 |
| PLA Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| PLA Increase, Below (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Increase Within (B)-Below (D8) | 0 | 0 | 0 |
| PLA Increase Within (B)-Within (D8) | 67 | 72 | 63 |
| PLA Increase Within (B)-Above (D8) | 0 | 0 | 0 |
| PLA Increase Within (B)-Unknown (D8) | 2 | 2 | 2 |
| PLA Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| PLA Increase Above (B)-Within (D8) | 0 | 0 | 1 |
| PLA Increase Above (B)-Above (D8) | 0 | 0 | 0 |
| PLA Increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| PLA Increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| PLA Increase Unknown (B)-Within (D8) | 0 | 0 | 2 |
| PLA Increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| PLA Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| WBC Decrease Below (B)-Below (D8) | 0 | 0 | 0 |
| WBC Decrease Below (B)-Within (D8) | 0 | 0 | 0 |
| WBC Decrease Below (B)-Above (D8) | 0 | 0 | 0 |
| WBC Decrease Below (B)-Unknown (D8) | 0 | 0 | 0 |
| WBC Decrease Within (B)-Below (D8) | 0 | 0 | 0 |
| WBC Decrease Within (B)-Within (D8) | 46 | 48 | 46 |
| WBC Decrease Within (B)-Above (D8) | 5 | 8 | 5 |
| WBC Decrease Within (B)-Unknown (D8) | 1 | 1 | 2 |
| WBC Decrease Above (B)-Below (D8) | 0 | 0 | 0 |
| WBC Decrease Above (B)-Within (D8) | 3 | 5 | 3 |
| WBC Decrease Above (B)-Above (D8) | 14 | 12 | 10 |
| WBC Decrease Above (B)-Unknown (D8) | 1 | 1 | 0 |
| WBC Decrease Unknown (B)-Below (D8) | 0 | 0 | 0 |
| WBC Decrease Unknown (B)-Within (D8) | 0 | 0 | 1 |
| WBC Decrease Unknown (B)-Above (D8) | 0 | 0 | 1 |
| WBC Decrease Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| WBC Increase Below (B)-Below (D8) | 0 | 0 | 0 |
| WBC Increase Below (B)-Within (D8) | 0 | 0 | 0 |
| WBC Increase Below (B)-Above (D8) | 0 | 0 | 0 |
| WBC Increase Below (B)-Unknown (D8) | 0 | 0 | 0 |
| WBC Increase Within (B)-Below (D8) | 0 | 0 | 0 |
| WBC Increase Within (B)-Within (D8) | 46 | 48 | 46 |
| WBC Increase Within (B)- Above (D8) | 5 | 8 | 5 |
| WBC Increase Within (B)-Unknown (D8) | 1 | 1 | 2 |
| WBC Increase Above (B)-Below (D8) | 0 | 0 | 0 |
| WBC Increase Above (B)-Within (D8) | 3 | 5 | 3 |
| WBC Increase Above (B)-Above (D8) | 14 | 12 | 10 |
| WBC Increase Above (B)- Unknown (D8) | 1 | 1 | 0 |
| WBC Increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| WBC Increase Unknown (B)-Within (D8) | 0 | 0 | 1 |
| WBC Increase Unknown (B)-Above (D8) | 0 | 0 | 1 |
| WBC Increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'AST increase Below (B) - Within (D8)' = AST increase in subjects with below normal values at baseline and within normal values at Day 8.
| Participants | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| ALT increase Below (B)-Below (D8) | 0 | 0 | 0 |
| ALT increase Below (B)- Within (D8) | 0 | 0 | 0 |
| ALT increase Below (B)- Above (D8) | 0 | 0 | 0 |
| ALT increase Below (B)-Unknown (D8) | 0 | 0 | 0 |
| ALT increase Within (B)- Below (D8) | 0 | 0 | 0 |
| ALT increase Within (B)-Within (D8) | 64 | 69 | 65 |
| ALT increase Within (B)- Above (D8) | 1 | 0 | 0 |
| ALT increase Within (B)-Unknown (D8) | 2 | 3 | 1 |
| ALT increase Above (B)- Below (D8) | 0 | 0 | 0 |
| ALT increase Above (B)- Within (D8) | 1 | 2 | 0 |
| ALT increase Above (B)- Above (D8) | 1 | 1 | 0 |
| ALT increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| ALT increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| ALT increase Unknown (B)-Within (D8) | 1 | 0 | 2 |
| ALT increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| ALT increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| AST increase Below (B)-Below (D8) | 0 | 0 | 0 |
| AST increase Below (B)- Within (D8) | 0 | 0 | 0 |
| AST increase Below (B)- Above (D8) | 0 | 0 | 0 |
| AST increase Below (B)-Unknown (D8) | 0 | 0 | 0 |
| AST increase Within (B)- Below (D8) | 0 | 0 | 0 |
| AST increase Within (B)-Within (D8) | 67 | 71 | 65 |
| AST increase Within (B)- Above (D8) | 0 | 1 | 0 |
| AST increase Within (B)-Unknown (D8) | 1 | 2 | 1 |
| AST increase Above (B)- Below (D8) | 0 | 0 | 0 |
| AST increase Above (B)-Within (D8) | 0 | 1 | 0 |
| AST increase Above (B)-Above (D8) | 1 | 0 | 0 |
| AST increase Above (B)-Unknown (D8) | 0 | 0 | 0 |
| AST increase Unknown (B)-Below (D8) | 0 | 0 | 0 |
| AST increase Unknown (B)-Within (D8) | 1 | 0 | 2 |
| AST increase Unknown (B)-Above (D8) | 0 | 0 | 0 |
| AST increase Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| Creatinine Below (B)-Below (D8) | 16 | 18 | 18 |
| Creatinine Below (B)-Within (D8) | 6 | 9 | 4 |
| Creatinine Below (B)-Above (D8) | 0 | 0 | 0 |
| Creatinine Below (B)- Unknown (D8) | 0 | 0 | 1 |
| Creatinine Within (B)-Below (D8) | 2 | 4 | 6 |
| Creatinine Within (B)-Within (D8) | 45 | 42 | 37 |
| Creatinine Within (B)-Above (D8) | 0 | 0 | 0 |
| Creatinine Within (B)-Unknown (D8) | 1 | 2 | 0 |
| Creatinine Above (B)-Below (D8) | 0 | 0 | 0 |
| Creatinine Above (B)-Within (D8) | 0 | 0 | 0 |
| Creatinine Above (B)-Above (D8) | 0 | 0 | 0 |
| Creatinine Above (B)-Unknown (D8) | 0 | 0 | 0 |
| Creatinine Unknown (B)-Below (D8) | 0 | 0 | 1 |
| Creatinine Unknown (B)-Within (D8) | 0 | 0 | 1 |
| Creatinine Unknown (B)-Above (D8) | 0 | 0 | 0 |
| Creatinine Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
| URN Below (B)-Below (D8) | 13 | 15 | 13 |
| URN Below (B)-Within (D8) | 6 | 4 | 3 |
| URN Below (B)-Above (D8) | 0 | 0 | 0 |
| URN Below (B)-Unknown (D8) | 0 | 1 | 1 |
| URN Within (B)-Below (D8) | 5 | 4 | 9 |
| URN Within (B)-Within (D8) | 45 | 49 | 39 |
| URN Within (B)-Above (D8) | 0 | 0 | 0 |
| URN Within (B)-Unknown (D8) | 1 | 1 | 0 |
| URN Above (B)-Below (D8) | 0 | 0 | 0 |
| URN Above (B)-Within (D8) | 0 | 0 | 0 |
| URN Above (B)-Above (D8) | 0 | 0 | 0 |
| URN Above (B)-Unknown (D8) | 0 | 0 | 0 |
| URN Unknown (B)-Below (D8) | 0 | 0 | 0 |
| URN Unknown (B)-Within (D8) | 0 | 1 | 3 |
| URN Unknown (B)-Above (D8) | 0 | 0 | 0 |
| URN Unknown (B)-Unknown (D8) | 0 | 0 | 0 |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs) | 30 (19.6 to 42.1) | 33.3 (22.9 to 45.2) | 33.8 (22.8 to 46.3) |
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs) | 22.9 (13.7 to 34.4) | 26.7 (17.1 to 38.1) | 22.1 (12.9 to 33.8) |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With AEs Leading to Study Withdrawal | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With Any Medically Attended AEs (MAE) | 41.4 (29.8 to 53.8) | 48 (36.3 to 59.8) | 42.6 (30.7 to 55.2) |
Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Live birth with no congenital anomalies | 84.3 (73.6 to 91.9) | 81.3 (70.7 to 89.4) | 80.9 (69.5 to 89.4) |
| Live birth with congenital anomalies | 12.9 (6.1 to 23) | 16 (8.6 to 26.3) | 16.2 (8.4 to 27.1) |
| Fetal death/still birth with no CA- Antepartum | 0 (0 to 5.1) | 0 (0 to 4.8) | 1.5 (0 to 7.9) |
| Unknown | 2.9 (0.3 to 9.9) | 2.7 (0.3 to 9.3) | 1.5 (0 to 7.9) |
Pregnancy-related AESIs were: Non-Reassuring Fetal Status, Hypertensive Disorders of Pregnancy (HDP), Oligohydramnios, Pathways to Preterm Birth (PPB), Chorioamnionitis, Fetal Growth Restriction, Gestational Liver Disease (GLD), Postpartum Haemorrhage and Gestational Diabetes Mellitus.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Non-Reassuring Fetal Status | 8.6 (3.2 to 17.7) | 12 (5.6 to 21.6) | 11.8 (5.2 to 21.9) |
| HDP-Gestational Hypertension | 4.3 (0.9 to 12) | 2.7 (0.3 to 9.3) | 1.5 (0 to 7.9) |
| HDP-Pre-Eclampsia | 5.7 (1.6 to 14) | 2.7 (0.3 to 9.3) | 0 (0 to 5.3) |
| Oligohydramnios | 4.3 (0.9 to 12) | 2.7 (0.3 to 9.3) | 1.5 (0 to 7.9) |
| PPB-Preterm Labor | 0 (0 to 5.1) | 2.7 (0.3 to 9.3) | 2.9 (0.4 to 10.2) |
| PPB-Preterm Rupture Of Membranes | 1.4 (0 to 7.7) | 0 (0 to 4.8) | 1.5 (0 to 7.9) |
| PPB-Provider-Initiated Preterm Birth | 0 (0 to 5.1) | 1.3 (0 to 7.2) | 0 (0 to 5.3) |
| Chorioamnionitis | 2.9 (0.3 to 9.9) | 2.7 (0.3 to 9.3) | 1.5 (0 to 7.9) |
| Fetal Growth Restriction | 1.4 (0 to 7.7) | 2.7 (0.3 to 9.3) | 0 (0 to 5.3) |
| GLD-Intrahepatic Cholestasis Of Pregnancy | 2.9 (0.3 to 9.9) | 1.3 (0 to 7.2) | 0 (0 to 5.3) |
| Postpartum Haemorrhage | 1.4 (0 to 7.7) | 0 (0 to 4.8) | 1.5 (0 to 7.9) |
| Gestational Diabetes Mellitus | 1.4 (0 to 7.7) | 0 (0 to 4.8) | 0 (0 to 5.3) |
Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Respiratory Distress In The Neonate | 6 (1.7 to 14.6) | 6.8 (2.3 to 15.3) | 6.1 (1.7 to 14.8) |
| Macrosomia | 3 (0.4 to 10.4) | 2.7 (0.3 to 9.5) | 7.6 (2.5 to 16.8) |
| Low Birth Weight | 1.5 (0 to 8) | 5.5 (1.5 to 13.4) | 3 (0.4 to 10.5) |
| Small For Gestational Age | 3 (0.4 to 10.4) | 4.1 (0.9 to 11.5) | 3 (0.4 to 10.5) |
| Preterm Birth | 1.5 (0 to 8) | 4.1 (0.9 to 11.5) | 3 (0.4 to 10.5) |
| Large For Gestational Age | 3 (0.4 to 10.4) | 0 (0 to 4.9) | 4.5 (0.9 to 12.7) |
| NIBSI: Bacterial/Fungal/Viral | 0 (0 to 5.4) | 1.4 (0 to 7.4) | 1.5 (0 to 8.2) |
| NIBSI: Bacterial/Fungal/Viral Meningitis | 0 (0 to 5.4) | 1.4 (0 to 7.4) | 0 (0 to 5.4) |
| NIBSI: Respiratory Bacterial/Fungal/Viral Infection | 0 (0 to 5.4) | 0 (0 to 4.9) | 1.5 (0 to 8.2) |
| CA- Major External Structural Defects | 0 (0 to 5.4) | 2.7 (0.3 to 9.5) | 0 (0 to 5.4) |
| CA- Functional Defects | 0 (0 to 5.4) | 1.4 (0 to 7.4) | 0 (0 to 5.4) |
| CA- Internal Structural Defects | 0 (0 to 5.4) | 1.4 (0 to 7.4) | 0 (0 to 5.4) |
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any SAEs | 22.4 (13.1 to 34.2) | 27.4 (17.6 to 39.1) | 28.8 (18.3 to 41.3) |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With AEs Leading to Study Withdrawal | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any MAEs | 25.4 (15.5 to 37.5) | 35.6 (24.7 to 47.7) | 30.3 (19.6 to 42.9) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.
| EU/mL | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Day 1 | 5681 (4851 to 6653) | 5837 (4962 to 6865) | 6147 (5224 to 7234) |
| Day 31 | 80986 (66746 to 98263) | 105138 (93657 to 118025) | 6597 (5252 to 8288) |
| Delivery | 59395 (50742 to 69524) | 59715 (51417 to 69352) | 5555 (4568 to 6755) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
| Titers | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Day 1 | 671.8 (544.1 to 829.4) | 694.7 (565.8 to 852.9) | 735.6 (586.7 to 922.1) |
| Day 31 | 9534.2 (7758.5 to 11716.3) | 10781.2 (9150 to 12703.2) | 799.1 (622.2 to 1026.2) |
| Delivery | 6162.1 (4981.2 to 7623) | 6661 (5490.7 to 8080.7) | 761.1 (612.1 to 946.3) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
| EU/mL | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects | 91606.9 (76414.1 to 109820.3) | 114529.8 (100023.3 to 131140.1) | 9272.3 (7669.8 to 11209.5) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects | 8414.7 (6813.4 to 10392.5) | 10262.5 (8709.9 to 12091.9) | 1244.7 (981.3 to 1578.8) |
The placental transfer ratio of IgG specific antibody concentration was determined from cord blood (or blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA.
| Ratio | RSV MAT 60 Group | RSV MAT 120 Group | Control Group |
|---|---|---|---|
| Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations | 1.62 (1.44 to 1.82) | 1.9 (1.75 to 2.06) | 1.6 (1.47 to 1.75) |
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery | 22.9 (13.7 to 34.4) | 28 (18.2 to 39.6) | 22.1 (12.9 to 33.8) |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery | 47.1 (35.1 to 59.4) | 53.3 (41.4 to 64.9) | 47.1 (34.8 to 59.6) |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth | 25.4 (15.5 to 37.5) | 28.8 (18.8 to 40.6) | 30.3 (19.6 to 42.9) |
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth | 40.3 (28.5 to 53) | 52.1 (40 to 63.9) | 39.4 (27.6 to 52.2) |
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth | 25.4 (15.5 to 37.5) | 28.8 (18.8 to 40.6) | 31.8 (20.9 to 44.4) |
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth | 0 (0 to 0) | 0 (0 to 0) | 0 (0 to 0) |
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth | 43.3 (31.2 to 56) | 57.5 (45.4 to 69) | 43.9 (31.7 to 56.7) |
A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.
| Percentage of maternal subjects | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI) | 0 (0 to 5.1) | 0 (0 to 4.8) | 0 (0 to 5.3) |
An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (\<) 95% or respiratory rate increase and a confirmed RSV infection.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI) | 0 (0 to 5.4) | 0 (0 to 4.9) | 0 (0 to 5.4) |
A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 93% or lower chest wall in-drawing and a confirmed RSV infection.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With RSV-associated Severe LRTI | 0 (0 to 5.4) | 0 (0 to 4.9) | 0 (0 to 5.4) |
A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 \< 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With RSV-associated Very Severe LRTI | 0 (0 to 5.4) | 0 (0 to 4.9) | 0 (0 to 5.4) |
An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
| Percentage of infant subjects | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| Percentage of Infant Subjects With RSV-associated Hospitalisation | 0 (0 to 5.4) | 0 (0 to 4.9) | 0 (0 to 5.4) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
| EU/mL | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery | 61925 (51966 to 73792) | 62871 (53878 to 73364) | 8350 (6723 to 10372) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery | 6451.3 (4842.4 to 8594.6) | 6290.7 (5000.6 to 7913.7) | 943.6 (733.4 to 1213.9) |
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother |
|---|---|---|---|
| Day 1 | 1066.3 (833.7 to 1363.9) | 1144.7 (933.1 to 1404.4) | 969.5 (790.5 to 1188.9) |
| Day 31 | 13766.2 (10692.6 to 17723.2) | 15849.4 (13101 to 19174.4) | 1065.8 (846.5 to 1341.8) |
| Delivery | 8983.1 (7079.7 to 11398.1) | 13335.6 (10507 to 16925.8) | 1190.7 (922.8 to 1536.5) |
| Day 43 post-delivery | 12297.7 (9464.3 to 15979.4) | 10027.2 (8033.2 to 12516.2) | 1473.8 (1111.1 to 1954.8) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
| EU/mL | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth | 30194.5 (18677.2 to 48813.8) | 39378.2 (33586.7 to 46168.4) | 2576.1 (1566.4 to 4236.5) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
| EU/mL | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth | 4292.9 (3263 to 5648) | 4656.9 (3539.4 to 6127.4) | 445.5 (291.4 to 681) |
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
| EU/mL | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth | 1224.1 (815.1 to 1838.4) | 1433.5 (1116.7 to 1840.1) | 179.6 (97.7 to 330.3) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth | 3384.2 (2200.1 to 5205.5) | 3509.6 (2525.2 to 4877.6) | 613.3 (298.6 to 1259.8) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth | 762.3 (458.3 to 1268.2) | 890.9 (648.5 to 1224) | 91.2 (56.8 to 146.5) |
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth | 278.4 (146 to 530.9) | 324.8 (194.6 to 542.3) | 47.8 (23.8 to 96) |
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth | 13585.6 (10453.9 to 17655.4) | 18955 (15694.7 to 22892.6) | 1656.8 (1320.3 to 2079) |
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth | 5932.1 (2562.6 to 13731.7) | 6905.5 (4373.3 to 10903.8) | 548.2 (292.1 to 1028.8) |
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth | 1119 (705.3 to 1775.4) | 1367 (950.5 to 1965.9) | 141.6 (82 to 244.6) |
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
| Titers | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|
| RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth | 459.8 (245.9 to 859.7) | 574 (368.9 to 893.3) | 68.8 (27.1 to 174.7) |
Collected over For maternal groups, administration site and systemic events were collected during the 7-day follow-up period after vaccination and unsolicited adverse events during the 30-day follow-up period after vaccination. Serious adverse events were collected from Day 1 up to Month 6 post-Delivery in mothers and from Birth up to 12 months in infants.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RSV MAT 60 Group-Mother | 0/70 (0%) | 16/70 (22.9%) | 56/70 (80%) |
| RSV MAT 120 Group-Mother | 0/75 (0%) | 21/75 (28%) | 66/75 (88%) |
| Control Group-Mother | 0/68 (0%) | 15/68 (22.1%) | 47/68 (69.1%) |
| RSV MAT 60 Group-Infant | 0/67 (0%) | 17/67 (25.4%) | — |
| RSV MAT 120 Group-Infant | 0/73 (0%) | 21/73 (28.8%) | — |
| Control Group-Infant | 0/66 (0%) | 21/66 (31.8%) | — |
| Event | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|---|---|---|
| Foetal distress syndromePregnancy, puerperium and perinatal conditions | 2/70 | 9/75 | 6/68 | 0/67 | 0/73 | 0/66 |
| Congenital naevusCongenital, familial and genetic disorders | 0/70 | 0/75 | 0/68 | 4/67 | 3/73 | 4/66 |
| Neonatal respiratory distressRespiratory, thoracic and mediastinal disorders | 0/70 | 0/75 | 0/68 | 2/67 | 2/73 | 4/66 |
| Ankyloglossia congenitalCongenital, familial and genetic disorders | 0/70 | 0/75 | 0/68 | 0/67 | 2/73 | 3/66 |
| Prolonged labourPregnancy, puerperium and perinatal conditions | 0/70 | 2/75 | 3/68 | 0/67 | 0/73 | 0/66 |
| Pre-eclampsiaPregnancy, puerperium and perinatal conditions | 3/70 | 2/75 | 0/68 | 0/67 | 0/73 | 0/66 |
| Premature babyPregnancy, puerperium and perinatal conditions | 0/70 | 0/75 | 0/68 | 1/67 | 3/73 | 1/66 |
| Foetal growth restrictionPregnancy, puerperium and perinatal conditions | 1/70 | 3/75 | 0/68 | 0/67 | 0/73 | 0/66 |
| Jaundice neonatalPregnancy, puerperium and perinatal conditions | 0/70 | 0/75 | 0/68 | 1/67 | 1/73 | 2/66 |
| MaculeSkin and subcutaneous tissue disorders | 0/70 | 0/75 | 0/68 | 2/67 | 0/73 | 1/66 |
| Event | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant |
|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 40/70 | 39/75 | 10/68 | — | — | — |
| FatigueGeneral disorders | 28/70 | 26/75 | 17/68 | — | — | — |
| HeadacheNervous system disorders | 25/70 | 21/75 | 14/68 | — | — | — |
| NauseaGastrointestinal disorders | 18/70 | 17/75 | 9/68 | — | — | — |
| Abdominal painGastrointestinal disorders | 9/70 | 17/75 | 7/68 | — | — | — |
| DiarrhoeaGastrointestinal disorders | 11/70 | 13/75 | 9/68 | — | — | — |
| VomitingGastrointestinal disorders | 5/70 | 7/75 | 4/68 | — | — | — |
| Injection site erythemaGeneral disorders | 1/70 | 5/75 | 0/68 | — | — | — |
| NasopharyngitisInfections and infestations | 0/70 | 1/75 | 4/68 | — | — | — |
| Injection site swellingGeneral disorders | 3/70 | 3/75 | 0/68 | — | — | — |
| Age, Customized(Participants) | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant | Total |
|---|---|---|---|---|---|---|---|
| 0 to 1 years | 0 | 0 | 0 | 67 | 73 | 66 | 206 |
| 18 < 35 years | 59 | 62 | 56 | 0 | 0 | 0 | 177 |
| >= 35 years | 11 | 13 | 12 | 0 | 0 | 0 | 36 |
| Sex: Female, Male(Participants) | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant | Total |
|---|---|---|---|---|---|---|---|
| Female | 70 | 75 | 68 | 28 | 30 | 37 | 308 |
| Male | 0 | 0 | 0 | 39 | 43 | 29 | 111 |
| Race/Ethnicity, Customized(Participants) | RSV MAT 60 Group-Mother | RSV MAT 120 Group-Mother | Control Group-Mother | RSV MAT 60 Group-Infant | RSV MAT 120 Group-Infant | Control Group-Infant | Total |
|---|---|---|---|---|---|---|---|
| AMERICAN INDIAN OR ALASKA NATIVE | 0 | 2 | 0 | 0 | 1 | 0 | 3 |
| ASIAN | 0 | 0 | 2 | 0 | 0 | 1 | 3 |
| BLACK OR AFRICAN AMERICAN | 12 | 12 | 13 | 12 | 9 | 9 | 67 |
| NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 3 | 1 | 0 | 3 | 2 | 1 | 10 |
| OTHER | 10 | 10 | 7 | 10 | 11 | 8 | 56 |
| UNKNOWN | 0 | 2 | 1 | 0 | 1 | 1 | 5 |
| WHITE | 45 | 48 | 45 | 42 | 49 | 46 | 275 |
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Supporting information: Study protocol, Sap, Icf, Csr
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Respiratory Syncytial Virus Infections→
GlaxoSmithKline