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Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT04126213
Collaborator
(none)
534
Enrollment
32
Locations
6
Arms
18.3
Actual Duration (Months)
16.7
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: RSV MAT 60 µg
  • Biological: RSV MAT 120 µg
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
534 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Data was collected in an observer-blind manner. The laboratory in charge of the sample testing was blinded to the intervention assignment, codes were used to link the subject and study (without any link to the intervention attributed to the subject) to each sample. Investigators remained blinded to each subject's assigned study intervention until the second analysis. After the second analysis, the study was not considered observer blind as the investigator brochure was updated to include safety information presented by treatment group. This led to inadvertent unblinding of investigators and site staff to some subjects' treatment assignments. The subjects themselves remained blinded throughout their participation in the study.
Primary Purpose:
Prevention
Official Title:
A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers
Actual Study Start Date :
Nov 5, 2019
Actual Primary Completion Date :
Jul 23, 2020
Actual Study Completion Date :
May 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: RSV MAT 60 Group-Mother

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
One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Experimental: RSV MAT 120 Group-Mother

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
One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Placebo Comparator: Control Group-Mother

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
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
No Intervention: RSV MAT 60 Group-Infant

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.
No Intervention: RSV MAT 120 Group-Infant

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.
No Intervention: Control Group-Infant

This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Maternal Subjects With Any Solicited Administration Site Events [During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)]

    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.

  2. Percentage of Maternal Subjects With Any Solicited Systemic Events [During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)]

    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.

  3. Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges [At Day 8]

    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.

  4. Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges [At Day 8]

    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.

  5. Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs) [During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)]

    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.

  6. Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs) [From Day 1 to Day 43 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.

  7. Percentage of Maternal Subjects With AEs Leading to Study Withdrawal [From Day 1 to Day 43 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.

  8. Percentage of Maternal Subjects With Any Medically Attended AEs (MAE) [From Day 1 to Day 43 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.

  9. Percentage of Maternal Subjects With Pregnancy Outcomes [From Day 1 to Day 43 post-delivery]

    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).

  10. Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs) [From Day 1 to Day 43 post-delivery]

    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.

  11. Percentage of Infant Subjects With Neonatal AESIs [From birth to Day 43 post-birth]

    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).

  12. Percentage of Infant Subjects With Any SAEs [From birth to Day 43 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, 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.

  13. Percentage of Infant Subjects With AEs Leading to Study Withdrawal [From birth to Day 43 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.

  14. Percentage of Infant Subjects With Any MAEs [From birth to Day 43 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.

  15. RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects [At Day 1 (before vaccination), Day 31 and at delivery]

    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.

  16. RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects [At Day 1 (before vaccination), Day 31 and at delivery]

    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.

  17. RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects [At delivery or within 3 days after birth]

    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).

  18. RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects [At delivery or within 3 days after birth]

    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).

  19. Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations [At delivery (for maternal subjects) or within 3 days after birth (for infants)]

    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.

Secondary Outcome Measures

  1. Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery [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.

  2. Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery [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.

  3. Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery [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.

  4. Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth [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.

  5. Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth [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.

  6. Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth [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.

  7. Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth [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.

  8. Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth [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.

  9. Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth [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.

  10. Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI) [From delivery to Day 181 post-delivery]

    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.

  11. Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI) [From birth to Day 181 post-birth]

    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.

  12. Percentage of Infant Subjects With RSV-associated Severe LRTI [From birth to Day 181 post-birth]

    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.

  13. Percentage of Infant Subjects With RSV-associated Very Severe LRTI [From birth to Day 181 post-birth]

    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.

  14. Percentage of Infant Subjects With RSV-associated Hospitalisation [From birth to Day 181 post-birth]

    An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.

  15. RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery [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.

  16. RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery [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.

  17. RSV-B Neutralizing Antibody GMTs in Maternal Subjects [At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-delivery]

    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.

  18. RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth [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.

  19. RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth [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.

  20. RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth [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.

  21. RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth [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.

  22. RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth [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.

  23. RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth [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.

  24. RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth [At delivery or within 3 days 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. 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).

  25. RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth [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.

  26. RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth [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.

  27. RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Maternal subjects

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

  • 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:

  • include consent for both the maternal subject's participation and participation of the infant after the infant's birth, or

  • include consent for the maternal subject's participation and expressed willingness to consider permitting the infant to take part after the infant's birth.

  • Both mother and father should consent if local regulations/guidelines require it.

  • Age 18 to 40 years, inclusive, when informed consent is given.

  • Pre-pregnancy BMI 18.5 to 34.9, inclusive

  • Healthy as established by medical history and clinical examination before entering into the study.

  • At 280/7 to 336/7 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

  • Subject satisfying screening requirements

  • Singleton pregnancy

  • HIV negative, as assessed by local standard of care serologic tests conducted during the current pregnancy and before enrolment (Visit 1).

  • No fetal genetic abnormalities.

  • No significant congenital malformations, as assessed by level 2 ultrasound (also known as a fetal anomaly ultrasound scan or fetal morphology assessment) conducted after 18 weeks of gestation

  • Willing to provide cord blood

  • Willing to have the infant followed-up after delivery for a period of 12 months

  • Does not plan after delivery to give the infant for adoption or place the infant in care Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be enrolled if they meet all inclusion criteria and none of the exclusion criteria.

Infant subjects

  • Live-born from the study pregnancy.

  • 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 legally authorized representative, as applicable by local law, before performing any study specific procedure.

Exclusion Criteria:

Maternal subjects

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 such as:

  • Gestational hypertension at ≥20 weeks of gestation in the absence of proteinuria in a woman with a previously normal blood pressure

  • Gestational diabetes which is not controlled by diet and exercise

  • Pre-eclampsia

  • Eclampsia during current pregnancy

  • Intrauterine growth restriction

  • Placenta previa

  • Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that in the opinion of Investigator can impair the maternal-fetal circulation

  • Polyhydramnios

  • Oligohydramnios

  • Cervical suture in place

  • Preterm labour or history of preterm labour in the current pregnancy

  • Ongoing medical intervention to prevent preterm delivery or medical treatment for suspected preterm delivery

  • Cholestasis

  • Other pregnancy-related complications that in the Investigator's judgement would preclude participation of the subjects in an investigational vaccine trial or might pose risk to the subject due to participation in the study

  • Significant structural abnormalities of the uterus or cervix

  • History of prior stillbirth or neonatal death

  • History of preterm birth

  • History of ≥2 spontaneous abortions

  • Known or suspected HBV or HCV infection, based on medical history and clinical presentation

  • Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex, based on medical history and clinical presentation

  • Active infection with tuberculosis, based on medical history and clinical presentation

  • Known or suspected impairment of the immune system or autoimmune disorder (based on medical history and physical examination; no laboratory testing required)

  • Lymphoproliferative disorder or malignancy within 5 years before vaccination (excluding effectively treated non-melanoma skin cancer)

  • Any clinically significant grade 1 hematological and/or biochemical laboratory abnormalities identified at screening, which are clinically significant for pregnant women in the second and third trimester

  • Grade ≥ 2 hematological and/or biochemical laboratory abnormalities identified at screening being clinically significant for pregnant women in the second and third trimester

  • Acute or chronic clinically significant conditions, that might pose additional risk to the subject due to participation in the study

  • Any conditions that, may interfere with subject'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 a COVID-19 vaccine.

  • Prior receipt of an RSV vaccine

  • Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period beginning 29 days before the dose of study vaccine/product or planned use during the study period

  • Planned administration/administration of any vaccine within 29 days before study vaccine administration and through Day 43 post-delivery, except seasonal influenza vaccines and dTpa/Tdap or tetanus, which may be administered according to standard of care ≥ 15 days before or after study vaccination

  • Administration of immunoglobulins, blood products or plasma derivatives within 3 months before study vaccination or planned administration through Visit 5

  • 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:

  • Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies;

  • Prednisone, ≥ 5 mg/day or equivalent for ≥ 14 days. Topical, steroids are allowed. Inhaled steroids are allowed if ≤ 500µg/day of beclomethasone or fluticasone, or ≤ 800µg/day of budesonide.

Prior/Concomitant clinical study experience

  • Previous participation in a clinical trial of an RSV vaccine

  • Concurrently participating in another clinical study, in which the subject 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 the presence of two or more abuse criteria

  • A local condition that precludes injection of the study drug or precludes assessment of local reactogenicity

  • Consanguinity of maternal subject and her partner (second degree cousins or closer)

  • Any study personnel or their immediate dependants, family, or household members

Infant subjects

  • Concurrently participating in another clinical study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product

  • Child in care

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Phoenix Arizona United States 85015
2 GSK Investigational Site Huntington Park California United States 90255
3 GSK Investigational Site Los Angeles California United States 90057
4 GSK Investigational Site Nampa Idaho United States 83687
5 GSK Investigational Site Metairie Louisiana United States 70006
6 GSK Investigational Site Gulfport Mississippi United States 39503
7 GSK Investigational Site Saint Louis Missouri United States 63141
8 GSK Investigational Site Albuquerque New Mexico United States 87102
9 GSK Investigational Site Johnson City New York United States 13790
10 GSK Investigational Site Englewood Ohio United States 45322
11 GSK Investigational Site Beaumont Texas United States 77702
12 GSK Investigational Site Fort Worth Texas United States 76104
13 GSK Investigational Site Plano Texas United States 75093
14 GSK Investigational Site South Brisbane Queensland Australia 4101
15 GSK Investigational Site Melbourne Victoria Australia 3168
16 GSK Investigational Site Halifax Nova Scotia Canada B3K 6R8
17 GSK Investigational Site Québec Canada G1V 4G2
18 GSK Investigational Site Helsinki Finland 00290
19 GSK Investigational Site Clermont Ferrand France 63100
20 GSK Investigational Site Saint Etienne Cedex 02 France 42055
21 GSK Investigational Site Auckland New Zealand 1010
22 GSK Investigational Site Wellington New Zealand 6021
23 GSK Investigational Site Panama City Panama 32401
24 GSK Investigational Site Panama Panama 0801
25 GSK Investigational Site Soweto Gauteng South Africa 2013
26 GSK Investigational Site Malaga Andalucia Spain 29004
27 GSK Investigational Site Barcelona Spain 08035
28 GSK Investigational Site Burgos Spain 09006
29 GSK Investigational Site Madrid Spain 28041
30 GSK Investigational Site Madrid Spain 28046
31 GSK Investigational Site Majadahonda (Madrid) Spain 28222
32 GSK Investigational Site Marbella Spain 29600

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04126213
Other Study ID Numbers:
  • 209544
  • 2019-001991-12
First Posted:
Oct 15, 2019
Last Update Posted:
Dec 13, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Out of 534 participants who signed the informed consent 213 maternal subjects were vaccinated, and 206 infants were born to those exposed mothers. Therefore, a total of 419 are considered exposed.
Arm/Group Title 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
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end. 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.
Period Title: Overall Study
STARTED 70 75 68 67 73 66
COMPLETED 58 70 59 54 67 55
NOT COMPLETED 12 5 9 13 6 11

Baseline Characteristics

Arm/Group Title 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
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end. 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. Total of all reporting groups
Overall Participants 70 75 68 67 73 66 419
Age, Customized (Count of Participants)
0 to 1 years
0
0%
0
0%
0
0%
67
100%
73
100%
66
100%
206
49.2%
18 < 35 years
59
84.3%
62
82.7%
56
82.4%
0
0%
0
0%
0
0%
177
42.2%
>= 35 years
11
15.7%
13
17.3%
12
17.6%
0
0%
0
0%
0
0%
36
8.6%
Sex: Female, Male (Count of Participants)
Female
70
100%
75
100%
68
100%
28
41.8%
30
41.1%
37
56.1%
308
73.5%
Male
0
0%
0
0%
0
0%
39
58.2%
43
58.9%
29
43.9%
111
26.5%
Race/Ethnicity, Customized (Count of Participants)
AMERICAN INDIAN OR ALASKA NATIVE
0
0%
2
2.7%
0
0%
0
0%
1
1.4%
0
0%
3
0.7%
ASIAN
0
0%
0
0%
2
2.9%
0
0%
0
0%
1
1.5%
3
0.7%
BLACK OR AFRICAN AMERICAN
12
17.1%
12
16%
13
19.1%
12
17.9%
9
12.3%
9
13.6%
67
16%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
3
4.3%
1
1.3%
0
0%
3
4.5%
2
2.7%
1
1.5%
10
2.4%
OTHER
10
14.3%
10
13.3%
7
10.3%
10
14.9%
11
15.1%
8
12.1%
56
13.4%
UNKNOWN
0
0%
2
2.7%
1
1.5%
0
0%
1
1.4%
1
1.5%
5
1.2%
WHITE
45
64.3%
48
64%
45
66.2%
42
62.7%
49
67.1%
46
69.7%
275
65.6%

Outcome Measures

1. Primary Outcome
Title Percentage of Maternal Subjects With Any Solicited Administration Site Events
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Solicited Safety Set (SSS), which included all the maternal subjects who received at least 1 dose of the study intervention and who had solicited safety data.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 66
Any Pain
57.1
52
15.2
Any Erythema
1.4
6.7
0
Any Swelling
4.3
4
0
2. Primary Outcome
Title Percentage of Maternal Subjects With Any Solicited Systemic Events
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the SSS, which included all the maternal subjects who received at least 1 dose of the study intervention and who had solicited safety data.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 66
Any Fatigue
40
34.7
25.8
Any Headache
34.3
28
19.7
Any Nausea
25.7
22.7
13.6
Any Vomiting
7.1
9.3
4.5
Any Diarrhea
14.3
17.3
13.6
Any Abdominal pain
12.9
22.7
9.1
Any Fever
0
0
0
3. Primary Outcome
Title Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Exposed Set-Maternal (ESM), which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
EOS Increase Below (B)-Below (D8)
6
8.6%
5
6.7%
2
2.9%
EOS Increase Below (B)-Within (D8)
6
8.6%
2
2.7%
4
5.9%
EOS Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
EOS Increase Below (B)-Unknown (D8)
0
0%
0
0%
1
1.5%
EOS Increase Within (B)-Below (D8)
2
2.9%
5
6.7%
2
2.9%
EOS Increase Within (B)-Within (D8)
53
75.7%
58
77.3%
56
82.4%
EOS Increase Within (B)-Above (D8)
0
0%
0
0%
0
0%
EOS Increase Within (B)-Unknown (D8)
2
2.9%
3
4%
1
1.5%
EOS Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
EOS Increase Above (B)-Within (D8)
0
0%
1
1.3%
0
0%
EOS Increase Above (B)-Above (D8)
1
1.4%
1
1.3%
0
0%
EOS Increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
EOS Increase Unknown(B)-Below (D8)
0
0%
0
0%
0
0%
EOS Increase Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
EOS Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
EOS Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
ERY Decrease Below (B)-Below (D8)
24
34.3%
35
46.7%
23
33.8%
ERY Decrease Below (B)-Within (D8)
4
5.7%
2
2.7%
5
7.4%
ERY Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Decrease Below (B)-Unknown (D8)
1
1.4%
2
2.7%
2
2.9%
ERY Decrease Within (B)-Below (D8)
6
8.6%
2
2.7%
7
10.3%
ERY Decrease Within (B)-Within (D8)
34
48.6%
34
45.3%
29
42.6%
ERY Decrease Within (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Decrease Within(B)-Unknown (D8)
1
1.4%
0
0%
0
0%
ERY Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
ERY Decrease Above (B)-Within (D8)
0
0%
0
0%
0
0%
ERY Decrease Above (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Decrease Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
ERY Decrease Unknown (B)-Below (D8)
0
0%
0
0%
2
2.9%
ERY Decrease Unknown (B)-Within (D8)
0
0%
0
0%
0
0%
ERY Decrease Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
ERY Increase Below (B)-Below (D8)
24
34.3%
35
46.7%
23
33.8%
ERY Increase Below (B)-Within (D8)
4
5.7%
2
2.7%
5
7.4%
ERY Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Increase Below (B)-Unknown (D8)
1
1.4%
2
2.7%
2
2.9%
ERY Increase Within (B)-Below (D8)
6
8.6%
2
2.7%
7
10.3%
ERY Increase Within (B)-Within (D8)
34
48.6%
34
45.3%
29
42.6%
ERY Increase Within (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Increase Within (B)-Unknown (D8)
1
1.4%
0
0%
0
0%
ERY Increase Above-Below (D8)
0
0%
0
0%
0
0%
ERY Increase Above (B)-Within (D8)
0
0%
0
0%
0
0%
ERY Increase Above (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
ERY Increase Unknown (B)-Below (D8)
0
0%
0
0%
2
2.9%
ERY Increase Unknown (B)-Within (D8)
0
0%
0
0%
0
0%
ERY Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
ERY Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
HEM Decrease Below (B)-Below (D8)
25
35.7%
26
34.7%
24
35.3%
HEM Decrease Below (B)-Within (D8)
2
2.9%
3
4%
2
2.9%
HEM Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Decrease Below (B)-Unknown (D8)
1
1.4%
1
1.3%
1
1.5%
HEM Decrease Within (B)-Below (D8)
7
10%
9
12%
7
10.3%
HEM Decrease Within (B)- Within (D8)
34
48.6%
35
46.7%
31
45.6%
HEM Decrease Within (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Decrease Within (B)-Unknown (D8)
1
1.4%
1
1.3%
1
1.5%
HEM Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
HEM Decrease Above (B)-Within (D8)
0
0%
0
0%
0
0%
HEM Decrease Above (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Decrease Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
HEM Decrease Unknown (B)-Below (D8)
0
0%
0
0%
2
2.9%
HEM Decrease Unknown (B)-Within (D8)
0
0%
0
0%
0
0%
HEM Decrease Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
HEM Increase Below (B)-Below (D8)
25
35.7%
26
34.7%
24
35.3%
HEM Increase Below (B)-Within (D8)
2
2.9%
3
4%
2
2.9%
HEM Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Increase Below (B)-Unknown (D8)
1
1.4%
1
1.3%
1
1.5%
HEM Increase Within (B)-Below (D8)
7
10%
9
12%
7
10.3%
HEM Increase Within (B)-Within (D8)
34
48.6%
35
46.7%
31
45.6%
HEM Increase Within (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Increase Within (B)-Unknown (D8)
1
1.4%
1
1.3%
1
1.5%
HEM Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
HEM Increase Above (B)-Within (D8)
0
0%
0
0%
0
0%
HEM Increase Above (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
HEM Increase Unknown (B)-Below (D8)
0
0%
0
0%
2
2.9%
HEM Increase Unknown (B)-Within (D8)
0
0%
0
0%
0
0%
HEM Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
HEM Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Decrease Below (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Decrease Below (B)-Within (D8)
0
0%
0
0%
1
1.5%
LYMP Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Decrease Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Decrease Within (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Decrease Within (B)-Within (D8)
68
97.1%
72
96%
63
92.6%
LYMP Decrease Within (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Decrease Within (B)-Unknown (D8)
2
2.9%
3
4%
2
2.9%
LYMP Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Decrease Above (B)-Within (D8)
0
0%
0
0%
0
0%
LYMP Decrease Above (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Decrease Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Decrease Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Decrease Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
LYMP Decrease Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Increase Below (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Increase Below (B)-Within (D8)
0
0%
0
0%
1
1.5%
LYMP Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Increase Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Increase Within (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Increase Within (B)-Within (D8)
68
97.1%
72
96%
63
92.6%
LYMP Increase Within (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Increase Within (B)-Unknown (D8)
2
2.9%
3
4%
2
2.9%
LYMP Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Increase Above (B)-Within (D8)
0
0%
0
0%
0
0%
LYMP Increase Above (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
LYMP Increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
LYMP Increase Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
LYMP Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
LYMP Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
MCV Decrease Below (B)-Below (D8)
2
2.9%
1
1.3%
1
1.5%
MCV Decrease Below (B)-Within (D8)
0
0%
0
0%
0
0%
MCV Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
MCV Decrease Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
MCV Decrease Within (B)-Below (D8)
0
0%
0
0%
1
1.5%
MCV Decrease Within (B)-Within (D8)
62
88.6%
66
88%
57
83.8%
MCV Decrease Within (B)-Above (D8)
2
2.9%
2
2.7%
1
1.5%
MCV Decrease Within (B)-Unknown (D8)
2
2.9%
1
1.3%
2
2.9%
MCV Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
MCV Decrease Above (B)-Within (D8)
0
0%
2
2.7%
1
1.5%
MCV Decrease Above (B)-Above (D8)
2
2.9%
2
2.7%
3
4.4%
MCV Decrease Above (B)-Unknown (D8)
0
0%
1
1.3%
0
0%
MCV Decrease Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
MCV Decrease Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
MCV Decrease Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
MCV Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
MCV Increase Below (B)-Below (D8)
2
2.9%
1
1.3%
1
1.5%
MCV Increase Below (B)-Within (D8)
0
0%
0
0%
0
0%
MCV Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
MCV Increase Below (B)- Unknown (D8)
0
0%
0
0%
0
0%
MCV Increase Within (B)-Below (D8)
0
0%
0
0%
1
1.5%
MCV Increase Within (B)-Within (D8)
62
88.6%
66
88%
57
83.8%
MCV Increase Within (B)-Above (D8)
2
2.9%
2
2.7%
1
1.5%
MCV Increase Within (B)-Unknown (D8)
2
2.9%
1
1.3%
2
2.9%
MCV Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
MCV Increase Above (B)-Within (D8)
0
0%
2
2.7%
1
1.5%
MCV Increase Above (B)-Above (D8)
2
2.9%
2
2.7%
3
4.4%
MCV Increase Above (B)-Unknown (D8)
0
0%
1
1.3%
0
0%
MCV Increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
MCV Increase Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
MCV Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
MCV Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
NEU Decrease Below (B)-Below (D8)
0
0%
0
0%
0
0%
NEU Decrease Below (B)-Within (D8)
0
0%
0
0%
0
0%
NEU Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
NEU Decrease Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
NEU Decrease Within (B)-Below (D8)
0
0%
0
0%
0
0%
NEU Decrease Within (B)-Within (D8)
42
60%
46
61.3%
41
60.3%
NEU Decrease Within (B)-Above (D8)
8
11.4%
9
12%
9
13.2%
NEU Decrease Within (B)-Unknown (D8)
0
0%
2
2.7%
1
1.5%
NEU Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
NEU Decrease Above (B)-Within (D8)
5
7.1%
5
6.7%
6
8.8%
NEU Decrease Above (B)-Above (D8)
13
18.6%
12
16%
8
11.8%
NEU Decrease Above (B)-Unknown (D8)
2
2.9%
1
1.3%
1
1.5%
NEU Decrease Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
NEU Decrease Unknown (B)-Within (D8)
0
0%
0
0%
1
1.5%
NEU Decrease Unknown (B)-Above (D8)
0
0%
0
0%
1
1.5%
NEU Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Decrease Below (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Decrease Below (B)-Within (D8)
1
1.4%
1
1.3%
0
0%
PLA Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Decrease Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Decrease Within (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Decrease Within (B)-Within (D8)
67
95.7%
72
96%
63
92.6%
PLA Decrease Within (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Decrease Within (B)-Unknown (D8)
2
2.9%
2
2.7%
2
2.9%
PLA Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Decrease Above (B)-Within (D8)
0
0%
0
0%
1
1.5%
PLA Decrease Above (B)- Above (D8)
0
0%
0
0%
0
0%
PLA Decrease Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Decrease Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Decrease Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
PLA Decrease Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Increase Below (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Increase Below (B)-Within (D8)
1
1.4%
1
1.3%
0
0%
PLA Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Increase, Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Increase Within (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Increase Within (B)-Within (D8)
67
95.7%
72
96%
63
92.6%
PLA Increase Within (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Increase Within (B)-Unknown (D8)
2
2.9%
2
2.7%
2
2.9%
PLA Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Increase Above (B)-Within (D8)
0
0%
0
0%
1
1.5%
PLA Increase Above (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
PLA Increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
PLA Increase Unknown (B)-Within (D8)
0
0%
0
0%
2
2.9%
PLA Increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
PLA Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
WBC Decrease Below (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Decrease Below (B)-Within (D8)
0
0%
0
0%
0
0%
WBC Decrease Below (B)-Above (D8)
0
0%
0
0%
0
0%
WBC Decrease Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
WBC Decrease Within (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Decrease Within (B)-Within (D8)
46
65.7%
48
64%
46
67.6%
WBC Decrease Within (B)-Above (D8)
5
7.1%
8
10.7%
5
7.4%
WBC Decrease Within (B)-Unknown (D8)
1
1.4%
1
1.3%
2
2.9%
WBC Decrease Above (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Decrease Above (B)-Within (D8)
3
4.3%
5
6.7%
3
4.4%
WBC Decrease Above (B)-Above (D8)
14
20%
12
16%
10
14.7%
WBC Decrease Above (B)-Unknown (D8)
1
1.4%
1
1.3%
0
0%
WBC Decrease Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Decrease Unknown (B)-Within (D8)
0
0%
0
0%
1
1.5%
WBC Decrease Unknown (B)-Above (D8)
0
0%
0
0%
1
1.5%
WBC Decrease Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
WBC Increase Below (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Increase Below (B)-Within (D8)
0
0%
0
0%
0
0%
WBC Increase Below (B)-Above (D8)
0
0%
0
0%
0
0%
WBC Increase Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
WBC Increase Within (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Increase Within (B)-Within (D8)
46
65.7%
48
64%
46
67.6%
WBC Increase Within (B)- Above (D8)
5
7.1%
8
10.7%
5
7.4%
WBC Increase Within (B)-Unknown (D8)
1
1.4%
1
1.3%
2
2.9%
WBC Increase Above (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Increase Above (B)-Within (D8)
3
4.3%
5
6.7%
3
4.4%
WBC Increase Above (B)-Above (D8)
14
20%
12
16%
10
14.7%
WBC Increase Above (B)- Unknown (D8)
1
1.4%
1
1.3%
0
0%
WBC Increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
WBC Increase Unknown (B)-Within (D8)
0
0%
0
0%
1
1.5%
WBC Increase Unknown (B)-Above (D8)
0
0%
0
0%
1
1.5%
WBC Increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
4. Primary Outcome
Title Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
ALT increase Below (B)-Below (D8)
0
0%
0
0%
0
0%
ALT increase Below (B)- Within (D8)
0
0%
0
0%
0
0%
ALT increase Below (B)- Above (D8)
0
0%
0
0%
0
0%
ALT increase Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
ALT increase Within (B)- Below (D8)
0
0%
0
0%
0
0%
ALT increase Within (B)-Within (D8)
64
91.4%
69
92%
65
95.6%
ALT increase Within (B)- Above (D8)
1
1.4%
0
0%
0
0%
ALT increase Within (B)-Unknown (D8)
2
2.9%
3
4%
1
1.5%
ALT increase Above (B)- Below (D8)
0
0%
0
0%
0
0%
ALT increase Above (B)- Within (D8)
1
1.4%
2
2.7%
0
0%
ALT increase Above (B)- Above (D8)
1
1.4%
1
1.3%
0
0%
ALT increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
ALT increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
ALT increase Unknown (B)-Within (D8)
1
1.4%
0
0%
2
2.9%
ALT increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
ALT increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
AST increase Below (B)-Below (D8)
0
0%
0
0%
0
0%
AST increase Below (B)- Within (D8)
0
0%
0
0%
0
0%
AST increase Below (B)- Above (D8)
0
0%
0
0%
0
0%
AST increase Below (B)-Unknown (D8)
0
0%
0
0%
0
0%
AST increase Within (B)- Below (D8)
0
0%
0
0%
0
0%
AST increase Within (B)-Within (D8)
67
95.7%
71
94.7%
65
95.6%
AST increase Within (B)- Above (D8)
0
0%
1
1.3%
0
0%
AST increase Within (B)-Unknown (D8)
1
1.4%
2
2.7%
1
1.5%
AST increase Above (B)- Below (D8)
0
0%
0
0%
0
0%
AST increase Above (B)-Within (D8)
0
0%
1
1.3%
0
0%
AST increase Above (B)-Above (D8)
1
1.4%
0
0%
0
0%
AST increase Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
AST increase Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
AST increase Unknown (B)-Within (D8)
1
1.4%
0
0%
2
2.9%
AST increase Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
AST increase Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
Creatinine Below (B)-Below (D8)
16
22.9%
18
24%
18
26.5%
Creatinine Below (B)-Within (D8)
6
8.6%
9
12%
4
5.9%
Creatinine Below (B)-Above (D8)
0
0%
0
0%
0
0%
Creatinine Below (B)- Unknown (D8)
0
0%
0
0%
1
1.5%
Creatinine Within (B)-Below (D8)
2
2.9%
4
5.3%
6
8.8%
Creatinine Within (B)-Within (D8)
45
64.3%
42
56%
37
54.4%
Creatinine Within (B)-Above (D8)
0
0%
0
0%
0
0%
Creatinine Within (B)-Unknown (D8)
1
1.4%
2
2.7%
0
0%
Creatinine Above (B)-Below (D8)
0
0%
0
0%
0
0%
Creatinine Above (B)-Within (D8)
0
0%
0
0%
0
0%
Creatinine Above (B)-Above (D8)
0
0%
0
0%
0
0%
Creatinine Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
Creatinine Unknown (B)-Below (D8)
0
0%
0
0%
1
1.5%
Creatinine Unknown (B)-Within (D8)
0
0%
0
0%
1
1.5%
Creatinine Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
Creatinine Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
URN Below (B)-Below (D8)
13
18.6%
15
20%
13
19.1%
URN Below (B)-Within (D8)
6
8.6%
4
5.3%
3
4.4%
URN Below (B)-Above (D8)
0
0%
0
0%
0
0%
URN Below (B)-Unknown (D8)
0
0%
1
1.3%
1
1.5%
URN Within (B)-Below (D8)
5
7.1%
4
5.3%
9
13.2%
URN Within (B)-Within (D8)
45
64.3%
49
65.3%
39
57.4%
URN Within (B)-Above (D8)
0
0%
0
0%
0
0%
URN Within (B)-Unknown (D8)
1
1.4%
1
1.3%
0
0%
URN Above (B)-Below (D8)
0
0%
0
0%
0
0%
URN Above (B)-Within (D8)
0
0%
0
0%
0
0%
URN Above (B)-Above (D8)
0
0%
0
0%
0
0%
URN Above (B)-Unknown (D8)
0
0%
0
0%
0
0%
URN Unknown (B)-Below (D8)
0
0%
0
0%
0
0%
URN Unknown (B)-Within (D8)
0
0%
1
1.3%
3
4.4%
URN Unknown (B)-Above (D8)
0
0%
0
0%
0
0%
URN Unknown (B)-Unknown (D8)
0
0%
0
0%
0
0%
5. Primary Outcome
Title Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Unsolicited Safety Set-Maternal, which included maternal subjects who received at least 1 dose of the study intervention (ESM) that reported unsolicited AEs/reported not having unsolicited AEs.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
30
33.3
33.8
6. Primary Outcome
Title Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
22.9
26.7
22.1
7. Primary Outcome
Title Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
0
0
0
8. Primary Outcome
Title Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
41.4
48
42.6
9. Primary Outcome
Title Percentage of Maternal Subjects With Pregnancy Outcomes
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Live birth with no congenital anomalies
84.3
81.3
80.9
Live birth with congenital anomalies
12.9
16
16.2
Fetal death/still birth with no CA- Antepartum
0
0
1.5
Unknown
2.9
2.7
1.5
10. Primary Outcome
Title Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Non-Reassuring Fetal Status
8.6
12
11.8
HDP-Gestational Hypertension
4.3
2.7
1.5
HDP-Pre-Eclampsia
5.7
2.7
0
Oligohydramnios
4.3
2.7
1.5
PPB-Preterm Labor
0
2.7
2.9
PPB-Preterm Rupture Of Membranes
1.4
0
1.5
PPB-Provider-Initiated Preterm Birth
0
1.3
0
Chorioamnionitis
2.9
2.7
1.5
Fetal Growth Restriction
1.4
2.7
0
GLD-Intrahepatic Cholestasis Of Pregnancy
2.9
1.3
0
Postpartum Haemorrhage
1.4
0
1.5
Gestational Diabetes Mellitus
1.4
0
0
11. Primary Outcome
Title Percentage of Infant Subjects With Neonatal AESIs
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Exposed Set-Infant (ESI), which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Respiratory Distress In The Neonate
6
6.8
6.1
Macrosomia
3
2.7
7.6
Low Birth Weight
1.5
5.5
3
Small For Gestational Age
3
4.1
3
Preterm Birth
1.5
4.1
3
Large For Gestational Age
3
0
4.5
NIBSI: Bacterial/Fungal/Viral
0
1.4
1.5
NIBSI: Bacterial/Fungal/Viral Meningitis
0
1.4
0
NIBSI: Respiratory Bacterial/Fungal/Viral Infection
0
0
1.5
CA- Major External Structural Defects
0
2.7
0
CA- Functional Defects
0
1.4
0
CA- Internal Structural Defects
0
1.4
0
12. Primary Outcome
Title Percentage of Infant Subjects With Any SAEs
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
22.4
27.4
28.8
13. Primary Outcome
Title Percentage of Infant Subjects With AEs Leading to Study Withdrawal
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
14. Primary Outcome
Title Percentage of Infant Subjects With Any MAEs
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
25.4
35.6
30.3
15. Primary Outcome
Title RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Per Protocol Set-Maternal (PPSM) for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 68 72 68
Day 1
5681
5837
6147
Day 31
80986
105138
6597
Delivery
59395
59715
5555
16. Primary Outcome
Title RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 68 73 68
Day 1
671.8
694.7
735.6
Day 31
9534.2
10781.2
799.1
Delivery
6162.1
6661
761.1
17. Primary Outcome
Title RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Per Protocol Set-Infants (PPSI), which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post-maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 59 64 60
Geometric Mean (95% Confidence Interval) [EU/mL]
91606.9
114529.8
9272.3
18. Primary Outcome
Title RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the PPSI, which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post-maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 60 64 61
Geometric Mean (95% Confidence Interval) [Titers]
8414.7
10262.5
1244.7
19. Primary Outcome
Title Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
Description 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)

Outcome Measure Data

Analysis Population Description
The analysis was performed on all pairs of maternal subjects (from PPSM) and their infants (from PPSI) with available results for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group RSV MAT 120 Group Control Group
Arm/Group Description This group consisted of pairs of maternal subjects from RSV MAT 60- Mother Group and infant subjects from RSV MAT 60-Infants Group. This group consisted of pairs of maternal subjects from RSV MAT 120- Mother Group and infant subjects from RSV MAT 120-Infants Group. This group consisted of pairs of maternal subjects from Control- Mother Group and infant subjects from Control-Infants Group.
Measure Participants 59 63 58
Geometric Mean (95% Confidence Interval) [Ratio]
1.62
1.9
1.6
20. Secondary Outcome
Title Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
22.9
28
22.1
21. Secondary Outcome
Title Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
47.1
53.3
47.1
22. Secondary Outcome
Title Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
0
0
0
23. Secondary Outcome
Title Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
25.4
28.8
30.3
24. Secondary Outcome
Title Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
25. Secondary Outcome
Title Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
40.3
52.1
39.4
26. Secondary Outcome
Title Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
25.4
28.8
31.8
27. Secondary Outcome
Title Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
28. Secondary Outcome
Title Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
43.3
57.5
43.9
29. Secondary Outcome
Title Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 70 75 68
Number (95% Confidence Interval) [Percentage of maternal subjects]
0
0
0
30. Secondary Outcome
Title Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
31. Secondary Outcome
Title Percentage of Infant Subjects With RSV-associated Severe LRTI
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
32. Secondary Outcome
Title Percentage of Infant Subjects With RSV-associated Very Severe LRTI
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
33. Secondary Outcome
Title Percentage of Infant Subjects With RSV-associated Hospitalisation
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the ESI, which included all the infants live-born to exposed maternal subjects, whose parents/LARs completed the informed consent process and signed the informed consent form.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 67 73 66
Number (95% Confidence Interval) [Percentage of infant subjects]
0
0
0
34. Secondary Outcome
Title RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 53 59 50
Geometric Mean (95% Confidence Interval) [EU/mL]
61925
62871
8350
35. Secondary Outcome
Title RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 53 58 50
Geometric Mean (95% Confidence Interval) [Titers]
6451.3
6290.7
943.6
36. Secondary Outcome
Title RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the PPSM for immunogenicity which included all the maternal subjects who received at least 1 dose of the study intervention to which they were randomized and have post-vaccination data minus those subjects with protocol deviations that lead to exclusion.
Arm/Group Title RSV MAT 60 Group-Mother RSV MAT 120 Group-Mother Control Group-Mother
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.
Measure Participants 67 73 68
Day 1
1066.3
1144.7
969.5
Day 31
13766.2
15849.4
1065.8
Delivery
8983.1
13335.6
1190.7
Day 43 post-delivery
12297.7
10027.2
1473.8
37. Secondary Outcome
Title RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 13 15 11
Geometric Mean (95% Confidence Interval) [EU/mL]
30194.5
39378.2
2576.1
38. Secondary Outcome
Title RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 17 19 10
Geometric Mean (95% Confidence Interval) [EU/mL]
4292.9
4656.9
445.5
39. Secondary Outcome
Title RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 11 19 11
Geometric Mean (95% Confidence Interval) [EU/mL]
1224.1
1433.5
179.6
40. Secondary Outcome
Title RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 13 15 11
Geometric Mean (95% Confidence Interval) [Titers]
3384.2
3509.6
613.3
41. Secondary Outcome
Title RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 17 19 10
Geometric Mean (95% Confidence Interval) [Titers]
762.3
890.9
91.2
42. Secondary Outcome
Title RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 11 20 12
Geometric Mean (95% Confidence Interval) [Titers]
278.4
324.8
47.8
43. Secondary Outcome
Title RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on the Per Protocol Set-Infants (PPSI), which included all infant subjects in the ESI who have post-delivery/birth immunogenicity data minus those who (a) were born less than 4 weeks post- maternal subject vaccination and/ or (b) have protocol deviations that lead to exclusion and for whom blood samples were collected at relevant time points.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 58 64 60
Geometric Mean (95% Confidence Interval) [Titers]
13585.6
18955
1656.8
44. Secondary Outcome
Title RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 13 15 11
Geometric Mean (95% Confidence Interval) [Titers]
5932.1
6905.5
548.2
45. Secondary Outcome
Title RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 17 19 10
Geometric Mean (95% Confidence Interval) [Titers]
1119
1367
141.6
46. Secondary Outcome
Title RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Description 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

Outcome Measure Data

Analysis Population Description
The analysis was performed on a subcohort (subcohort V2-New borns) from PPSI, for the subjects who provided sample for this outcome measure at the specified time point.
Arm/Group Title RSV MAT 60 Group-Infant RSV MAT 120 Group-Infant Control Group-Infant
Arm/Group Description 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.
Measure Participants 11 20 12
Geometric Mean (95% Confidence Interval) [Titers]
459.8
574
68.8

Adverse Events

Time Frame 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.
Adverse Event Reporting Description Infants born to vaccinated mothers were only monitored for AESIs and MAEs. These results are presented in the outcome measures section. Post vaccination solicited and unsolicited AEs were not collected for infants, as they were not vaccinated in the study.
Arm/Group Title 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
Arm/Group Description 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. 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. Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end. 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.
All Cause Mortality
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/70 (0%) 0/75 (0%) 0/68 (0%) 0/67 (0%) 0/73 (0%) 0/66 (0%)
Serious Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 16/70 (22.9%) 21/75 (28%) 15/68 (22.1%) 17/67 (25.4%) 21/73 (28.8%) 21/66 (31.8%)
Blood and lymphatic system disorders
Anaemia neonatal 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Cardiac disorders
Cardiomegaly 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Congenital, familial and genetic disorders
Congenital naevus 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 4/67 (6%) 4 3/73 (4.1%) 3 4/66 (6.1%) 4
Ankyloglossia congenital 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 2/73 (2.7%) 2 3/66 (4.5%) 3
Cryptorchism 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 1/66 (1.5%) 1
Hypospadias 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 2/73 (2.7%) 2 0/66 (0%) 0
Birth mark 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Congenital acrochordon 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Congenital arterial malformation 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Congenital foot malformation 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Congenital pneumonia 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Congenital skin dimples 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Congenital viral hepatitis 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Hooded prepuce 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Naevus flammeus 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Patent ductus arteriosus 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Phimosis 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Polydactyly 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Preauricular cyst 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Supernumerary nipple 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Ventricular septal defect 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Eye disorders
Dacryostenosis acquired 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Gastrointestinal disorders
Umbilical hernia 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 2/73 (2.7%) 2 0/66 (0%) 0
Constipation 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Inguinal hernia 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Meconium ileus 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
General disorders
Cyst 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Hepatobiliary disorders
Cholestasis of pregnancy 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Hyperbilirubinaemia 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Hyperbilirubinaemia neonatal 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Neonatal cholestasis 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Infections and infestations
Amniotic cavity infection 1/70 (1.4%) 1 2/75 (2.7%) 2 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Mastitis 1/70 (1.4%) 1 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Breast abscess 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Influenza 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Neonatal pneumonia 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Pyelonephritis 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Bacterial sepsis 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Meningitis viral 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Sepsis neonatal 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Urinary tract infection 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Injury, poisoning and procedural complications
Post lumbar puncture syndrome 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Road traffic accident 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Investigations
Cardiac murmur 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Infantile haemangioma 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Nervous system disorders
Bell's palsy 1/70 (1.4%) 1 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome 2/70 (2.9%) 2 9/75 (12%) 9 6/68 (8.8%) 6 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Pre-eclampsia 3/70 (4.3%) 3 2/75 (2.7%) 2 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Prolonged labour 0/70 (0%) 0 2/75 (2.7%) 2 3/68 (4.4%) 3 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Foetal growth restriction 1/70 (1.4%) 1 3/75 (4%) 3 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Oligohydramnios 2/70 (2.9%) 2 1/75 (1.3%) 1 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Gestational hypertension 2/70 (2.9%) 2 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Premature labour 0/70 (0%) 0 1/75 (1.3%) 1 2/68 (2.9%) 2 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Obstructed labour 0/70 (0%) 0 1/75 (1.3%) 1 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Premature delivery 0/70 (0%) 0 2/75 (2.7%) 2 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Preterm premature rupture of membranes 1/70 (1.4%) 1 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Arrested labour 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Breech presentation 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Foetal cardiac disorder 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Prolonged rupture of membranes 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Stillbirth 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Umbilical cord compression 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Premature baby 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 3/73 (4.1%) 3 1/66 (1.5%) 1
Jaundice neonatal 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 1/73 (1.4%) 1 2/66 (3%) 2
Low birth weight baby 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Renal and urinary disorders
Pelvi-ureteric obstruction 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 2/67 (3%) 2 2/73 (2.7%) 2 4/66 (6.1%) 4
Meconium aspiration syndrome 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 1/73 (1.4%) 1 0/66 (0%) 0
Choking 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Neonatal aspiration 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Neonatal respiratory depression 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Neonatal respiratory distress syndrome 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Neonatal respiratory failure 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 1/73 (1.4%) 1 0/66 (0%) 0
Tachypnoea 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Transient tachypnoea of the newborn 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 1/67 (1.5%) 1 0/73 (0%) 0 0/66 (0%) 0
Skin and subcutaneous tissue disorders
Macule 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 2/67 (3%) 3 0/73 (0%) 0 1/66 (1.5%) 1
Skin discolouration 0/70 (0%) 0 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 1/66 (1.5%) 1
Vascular disorders
Hypertension 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/67 (0%) 0 0/73 (0%) 0 0/66 (0%) 0
Other (Not Including Serious) Adverse Events
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 56/70 (80%) 66/75 (88%) 47/68 (69.1%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Blood and lymphatic system disorders
Anaemia of pregnancy 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Eye disorders
Vision blurred 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Gastrointestinal disorders
Nausea 18/70 (25.7%) 18 17/75 (22.7%) 17 9/68 (13.2%) 9 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Abdominal pain 9/70 (12.9%) 9 17/75 (22.7%) 18 7/68 (10.3%) 9 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Diarrhoea 11/70 (15.7%) 11 13/75 (17.3%) 13 9/68 (13.2%) 9 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Vomiting 5/70 (7.1%) 5 7/75 (9.3%) 7 4/68 (5.9%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Abdominal discomfort 0/70 (0%) 0 1/75 (1.3%) 1 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Abdominal pain lower 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Abdominal pain upper 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Constipation 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Dyspepsia 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Gastrointestinal disorder 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Mouth cyst 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Teething 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Toothache 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
General disorders
Injection site pain 40/70 (57.1%) 40 39/75 (52%) 39 10/68 (14.7%) 10 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Fatigue 28/70 (40%) 28 26/75 (34.7%) 28 17/68 (25%) 17 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Injection site erythema 1/70 (1.4%) 1 5/75 (6.7%) 5 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Injection site swelling 3/70 (4.3%) 3 3/75 (4%) 3 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Oedema peripheral 2/70 (2.9%) 2 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Influenza like illness 1/70 (1.4%) 1 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Asthenia 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Feeling hot 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Induration 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Injection site irritation 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Malaise 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Swelling 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Hepatobiliary disorders
Cholestasis of pregnancy 1/70 (1.4%) 1 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Immune system disorders
Seasonal allergy 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Infections and infestations
Nasopharyngitis 0/70 (0%) 0 1/75 (1.3%) 1 4/68 (5.9%) 4 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Urinary tract infection 2/70 (2.9%) 2 1/75 (1.3%) 1 2/68 (2.9%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Influenza 0/70 (0%) 0 3/75 (4%) 3 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Upper respiratory tract infection 0/70 (0%) 0 2/75 (2.7%) 2 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Acute sinusitis 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Asymptomatic bacteriuria 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Beta haemolytic streptococcal infection 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Fungal infection 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Hordeolum 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Respiratory tract infection 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Tooth abscess 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Injury, poisoning and procedural complications
Fall 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Musculoskeletal and connective tissue disorders
Back pain 1/70 (1.4%) 1 3/75 (4%) 3 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Pain in extremity 1/70 (1.4%) 1 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Arthralgia 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Groin pain 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Ligament pain 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Nervous system disorders
Headache 25/70 (35.7%) 25 21/75 (28%) 23 14/68 (20.6%) 14 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Dizziness 2/70 (2.9%) 2 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Migraine 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia 1/70 (1.4%) 1 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Uterine contractions during pregnancy 0/70 (0%) 0 2/75 (2.7%) 2 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Gestational diabetes 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Psychiatric disorders
Insomnia 0/70 (0%) 0 1/75 (1.3%) 1 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Depression 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Renal and urinary disorders
Glycosuria 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Nephrolithiasis 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Reproductive system and breast disorders
Vaginal haemorrhage 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Vulvovaginal discomfort 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain 1/70 (1.4%) 1 3/75 (4%) 3 2/68 (2.9%) 2 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Cough 1/70 (1.4%) 1 1/75 (1.3%) 1 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Nasal congestion 1/70 (1.4%) 1 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Asthma 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Asthmatic crisis 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Respiratory disorder 1/70 (1.4%) 1 0/75 (0%) 0 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Rhinorrhoea 0/70 (0%) 0 0/75 (0%) 0 1/68 (1.5%) 1 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Sinus congestion 0/70 (0%) 0 1/75 (1.3%) 2 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0
Skin and subcutaneous tissue disorders
Rash 0/70 (0%) 0 1/75 (1.3%) 1 0/68 (0%) 0 0/0 (NaN) 0 0/0 (NaN) 0 0/0 (NaN) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT04126213
Other Study ID Numbers:
  • 209544
  • 2019-001991-12
First Posted:
Oct 15, 2019
Last Update Posted:
Dec 13, 2021
Last Verified:
Nov 1, 2021