Study of Safety, Reactogenicity and Immunogenicity of Gla... | NCT04126213 | Trialant
NCT04126213
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Dec 13, 2021Actual
Enrollment
534Actual
Phase
Phase 2
Conditions
Respiratory Syncytial Virus Infections
Interventions
RSV MAT 60 µg
RSV MAT 120 µg
Placebo
Countries
United States
Australia
Canada
Finland
France
New Zealand
Panama
South Africa
Spain
Protocol Section
Identification Module
NCT ID
NCT04126213
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
209544
Secondary IDs
ID
Type
Description
Link
2019-001991-12
EudraCT Number
Brief Title
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
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
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Nov 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 5, 2019Actual
Primary Completion Date
Jul 23, 2020Actual
Completion Date
May 14, 2021Actual
First Submitted Date
Oct 11, 2019
First Submission Date that Met QC Criteria
Oct 11, 2019
First Posted Date
Oct 15, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Nov 12, 2021
Results First Submitted that Met QC Criteria
Nov 12, 2021
Results First Posted Date
Dec 13, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 16, 2021
Certification/Extension First Submitted that Passed QC Review
Apr 16, 2021
Certification/Extension First Posted Date
Apr 19, 2021Actual
Last Update Submitted Date
Nov 12, 2021
Last Update Posted Date
Dec 13, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Virus Infections
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
534Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
RSV MAT 60 Group-Mother
Experimental
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
RSV MAT 120 Group-Mother
Experimental
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
Control Group-Mother
Placebo Comparator
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
RSV MAT 60 Group-Infant
No Intervention
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.
RSV MAT 120 Group-Infant
No Intervention
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSV MAT 60 µg
Biological
One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
RSV MAT 60 Group-Mother
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Percentage of Maternal Subjects With Any Solicited Systemic Events
Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever [temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'WBC decrease Below (B) - Within (D8)' = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.
At Day 8
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'AST increase Below (B) - Within (D8)' = AST increase in subjects with below normal values at baseline and within normal values at Day 8.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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 28^0/7 to 33^6/7 weeks of gestation at the time of study vaccination (Visit 1), as established by last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S).
* If LMP and U/S do not correlate, default to U/S gestational age assessment. The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunisation safety Assessment in pregnancy gestation age assessment tool
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
Bebia Z, Reyes O, Jeanfreau R, Kantele A, De Leon RG, Sanchez MG, Banooni P, Gardener GJ, Rasero JLB, Pardilla MBE, Langley JM, Di Leo CM, Botelho-Nevers E, Buttery J, Laurichesse H, Madhi SA, Garcia AM, Stanley T, Barjat T, Griffith R, Castrejon-Alba MM, de Heusch M, Dieussaert I, Hercor M, Lese P, Qian H, Tullio AN, Henry O. Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. J Infect Dis. 2023 Aug 11;228(3):299-310. doi: 10.1093/infdis/jiad024.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
RSV MAT 120 Group-Mother
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 30, 2020
Nov 12, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
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.
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
RSV MAT 120 µg
Biological
One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
RSV MAT 120 Group-Mother
Placebo
Drug
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Control Group-Mother
At Day 8
Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Pregnancy Outcomes
Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).
From Day 1 to Day 43 post-delivery
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).
From birth to Day 43 post-birth
Percentage of Infant Subjects With Any SAEs
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From birth to Day 43 post-birth
Percentage of Infant Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
From birth to Day 43 post-birth
Percentage of Infant Subjects With Any MAEs
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade.
From birth to Day 43 post-birth
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.
At Day 1 (before vaccination), Day 31 and at delivery
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
At Day 1 (before vaccination), Day 31 and at delivery
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
At delivery or within 3 days after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
At delivery or within 3 days after birth
Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
The placental transfer ratio of IgG specific antibody concentration was determined from cord blood (or blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA.
At delivery (for maternal subjects) or within 3 days after birth (for infants)
From Day 1 to Day 181 post-delivery
Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From Day 1 to Day 181 post-delivery
Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
From Day 1 to Day 181 post-delivery
Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From birth to Day 181 post-birth
Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
From birth to Day 181 post-birth
Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From birth to Day 181 post-birth
Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From birth to Month 12 post-birth
Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
From birth to Month 12 post-birth
Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
From birth to Month 12 post-birth
Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.
From delivery to Day 181 post-delivery
Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (<) 95% or respiratory rate increase and a confirmed RSV infection.
From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Severe LRTI
A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 93% or lower chest wall in-drawing and a confirmed RSV infection.
From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Very Severe LRTI
A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.
From birth to Day 181 post-birth
Percentage of Infant Subjects With RSV-associated Hospitalisation
An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
From birth to Day 181 post-birth
RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
At Day 43 post-delivery
RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 43 post-delivery
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-delivery
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
At Day 43 after birth
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
At Day 121 after birth
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
At Day 181 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 43 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 121 after birth
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 181 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
At delivery or within 3 days after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 43 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
At Day 121 after birth
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
FG002
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.
FG003
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.
FG004
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.
FG005
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
FG00070 subjects
FG00175 subjects
FG00268 subjects
FG00367 subjects
FG00473 subjects
FG00566 subjects
COMPLETED
FG00058 subjects
FG00170 subjects
FG00259 subjects
FG00354 subjects
FG00467 subjects
FG00555 subjects
NOT COMPLETED
FG00012 subjects
FG0015 subjects
FG0029 subjects
FG00313 subjects
FG0046 subjects
FG00511 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0009 subjects
FG0011 subjects
FG0025 subjects
FG00310 subjects
FG0044 subjects
FG0057 subjects
Withdrawal by Subject
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
MIGRATED / MOVED FROM THE STUDY AREA
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00070
BG00175
BG00268
BG00367
BG00473
BG00566
BG006419
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
0 to 1 years
Title
Measurements
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00070
BG00175
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
BG0000
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Maternal Subjects With Any Solicited Administration Site Events
Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
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.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Units
Counts
Participants
OG00070
OG00175
OG00266
Title
Denominators
Categories
Any Pain
Title
Measurements
OG00057.1(44.7 to 68.9)
OG00152(40.2 to 63.7)
OG00215.2(7.5 to 26.1)
Any Erythema
Primary
Percentage of Maternal Subjects With Any Solicited Systemic Events
Assessed solicited systemic events were fatigue, headache, nausea, vomiting, diarrhea, abdominal pain and fever [temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.
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.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
During the 7-day follow-up period after vaccination (i.e. day of vaccination and 6 subsequent days)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Primary
Number of Maternal Subjects With Any Haematological Laboratory Abnormalities at Day 8 by Baseline Ranges
Hematological parameters assessed were Eosinophils (EOS), Erythrocytes (ERY), Hematocrit (HEM), Lymphocytes (LYMP), Mean Corpuscular Volume (MCV), Neutrophils (NEU), Platelets (PLA), and White Blood Cells (WBC) count. The increase and/or decrease of these parameters were evaluated at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'WBC decrease Below (B) - Within (D8)' = WBC decrease in subjects with below normal values at baseline and within normal values at Day 8.
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.
Posted
Count of Participants
Participants
At Day 8
ID
Title
Description
OG000
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.
OG001
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.
Primary
Number of Maternal Subjects With Any Biochemical Laboratory Abnormalities at Day 8 by Baseline Ranges
Biochemical parameters assessed were Alanine Amino-Transferase (ALT), Aspartate Amino-Transferase (AST), Creatinine (CRE) and Urea nitrogen (URN). The increase was evaluated only for AST and ALT parameters at Day 8. Abnormal laboratory values refer to range indicator at Day 8 (D8) categorized as Missing, Below, Within and Above normal values and compared to the baseline (B) range indicator of the same parameter, at Screening (up to 15 days before vaccination) i.e. Missing, Below, Within and Above. E.g. 'AST increase Below (B) - Within (D8)' = AST increase in subjects with below normal values at baseline and within normal values at Day 8.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
At Day 8
ID
Title
Description
OG000
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.
OG001
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.
OG002
Primary
Percentage of Maternal Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE is any AE reported in addition to those solicited during the clinical study and that was spontaneously communicated by a maternal subject. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
During 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
ID
Title
Description
OG000
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.
OG001
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.
Primary
Percentage of Maternal Subjects With Any Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
Primary
Percentage of Maternal Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Primary
Percentage of Maternal Subjects With Any Medically Attended AEs (MAE)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
Primary
Percentage of Maternal Subjects With Pregnancy Outcomes
Pregnancy outcomes were: live birth with no congenital anomalies, live birth with congenital anomalies, Fetal death/still birth with no Congenital Anomalies (CA) - Antepartum and Unknown (Subjects withdrew from the study before delivery and pregnancy outcome information was not available for them).
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Primary
Percentage of Maternal Subjects With Pregnancy-related Adverse Events of Special Interest (AESIs)
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Primary
Percentage of Infant Subjects With Neonatal AESIs
Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 43 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Primary
Percentage of Infant Subjects With Any SAEs
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or is a congenital anomaly/birth defect, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 43 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Primary
Percentage of Infant Subjects With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 43 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
Primary
Percentage of Infant Subjects With Any MAEs
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 43 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Primary
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations in Terms of Geometric Mean Concentrations (GMCs) in Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentrations were expressed in ELISA units per milliliter (EU/mL) and were measured on blood samples collected from vaccinated maternal subjects.
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 1 (before vaccination), Day 31 and at delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Mother
Primary
RSV-A Neutralizing Antibody Geometric Mean Titers (GMTs) in Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated maternal subjects.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1 (before vaccination), Day 31 and at delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Primary
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentrations were expressed in EU/mL. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At delivery or within 3 days after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
Primary
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were presented as GMTs, expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At delivery or within 3 days after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
Primary
Geometric Mean Ratio Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations
The placental transfer ratio of IgG specific antibody concentration was determined from cord blood (or blood sample collected within 3 days after birth from infants if cord blood was not collected) over that of the blood sample from mother at delivery if blood sample was not collected during delivery). Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA.
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.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At delivery (for maternal subjects) or within 3 days after birth (for infants)
ID
Title
Description
OG000
RSV MAT 60 Group
This group consisted of pairs of maternal subjects from RSV MAT 60- Mother Group and infant subjects from RSV MAT 60-Infants Group.
OG001
RSV MAT 120 Group
This group consisted of pairs of maternal subjects from RSV MAT 120- Mother Group and infant subjects from RSV MAT 120-Infants Group.
OG002
Control Group
This group consisted of pairs of maternal subjects from Control- Mother Group and infant subjects from Control-Infants Group.
Secondary
Percentage of Maternal Subjects With Any SAE From Day 1 to Day 181 Post Delivery
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject or abnormal pregnancy outcomes (spontaneous abortion, foetal death, stillbirth, congenital anomalies, ectopic pregnancy), other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 181 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Maternal Subjects With Any MAE From Day 1 to Day 181 Post Delivery
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 181 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Maternal Subjects With AE Leading to Study Withdrawal From Day 1 to Day 181 Post Delivery
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From Day 1 to Day 181 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Mother
Secondary
Percentage of Infant Subjects With Any SAE From Birth to Day 181 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Infant Subjects With AE Leading to Study Withdrawal From Birth to Day 181 Post-birth
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
Secondary
Percentage of Infant Subjects With Any MAE From Birth to Day 181 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Infant Subjects With Any SAE From Birth to Month 12 Post-birth
SAEs assessed included any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject, other situations (medical events that might jeopardize the participant or required medical/surgical intervention to prevent one of the other SAEs listed above: e.g. invasive/malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization). Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Month 12 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Infant Subjects With Any AE Leading to Study Withdrawal From Birth to Month 12 Post-birth
An AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs leading to study withdrawal = AEs identified by investigators to cause subject(s) withdrawal until the resolution of the event. These subject withdrawals were considered different from subject withdrawals for other reasons.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Month 12 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
Secondary
Percentage of Infant Subjects With Any MAE From Birth to Month 12 Post-birth
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Also, for instances where, due to the special circumstances, the subject could not seek medical advice for symptoms/an illness by visiting a medical facility or arranging for a home visit, the subject sought this advice instead via telephone, SMS, email, videotelephony or telemedicine, or other means. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Month 12 post-birth
ID
Title
Description
OG000
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.
OG001
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.
Secondary
Percentage of Maternal Subjects With RSV-associated Medically Attended Respiratory Tract Illnesses (MA-RTI)
A maternal MA-RTI occurs when the maternal subject visits a healthcare professional for any respiratory symptom, including cough, sputum production and difficulty breathing. An RSV associated MA-RTI is characterised by a medically attended visit for RTI symptoms (runny nose or blocked nose or cough) and a confirmed RSV infection.
The analysis was performed on the ESM, which included all the maternal subjects who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of maternal subjects
From delivery to Day 181 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
Percentage of Infant Subjects With RSV-associated Lower Respiratory Tract Illness (LRTI)
An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) lesser than (<) 95% or respiratory rate increase and a confirmed RSV infection.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
Percentage of Infant Subjects With RSV-associated Severe LRTI
A RSV-associated severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 93% or lower chest wall in-drawing and a confirmed RSV infection.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
Percentage of Infant Subjects With RSV-associated Very Severe LRTI
A RSV-associated very severe LRTI is characterised by a history of cough or difficulty in breathing, a SpO2 < 90% or inability to feed or failure to respond/unconscious and a confirmed RSV infection.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
Percentage of Infant Subjects With RSV-associated Hospitalisation
An RSV-associated hospitalisation is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
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.
Posted
Number
95% Confidence Interval
Percentage of infant subjects
From birth to Day 181 post-birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV MAT IgG Antibody GMCs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
RSV-A Neutralizing Antibody GMTs in Maternal Subjects, at Day 43 Post-delivery
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
RSV-B Neutralizing Antibody GMTs in Maternal Subjects
Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 1 (before vaccination), Day 31, at delivery and Day 43 post-delivery
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 43 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 121 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV MAT IgG Antibody GMCs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. The corresponding antibody concentration were expressed in EU/mL.
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.
Posted
Geometric Mean
95% Confidence Interval
EU/mL
At Day 181 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 43 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 121 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-A Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 181 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The antibodies were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 3 days after birth (if no cord blood sample could be obtained).
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At delivery or within 3 days after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Secondary
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 43 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 43 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 121 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 121 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
Secondary
RSV-B Neutralizing Antibody GMTs in Infants Born to Maternal Subjects, at Day 181 After Birth
Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60.
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.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 181 after birth
ID
Title
Description
OG000
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.
OG001
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.
OG002
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
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.
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
70
16
70
56
70
EG001
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.
0
75
21
75
66
75
EG002
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.
0
68
15
68
47
68
EG003
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.
0
67
17
67
0
0
EG004
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.
0
73
21
73
0
0
EG005
Control Group-Infant
This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.
0
66
21
66
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bell's palsy
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG0030 events0 affected67 at risk
EG0040 events0 affected73 at risk
EG0050 events0 affected66 at risk
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Hypertension
Vascular disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital naevus
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Ankyloglossia congenital
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cryptorchism
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Hypospadias
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Birth mark
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital acrochordon
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital arterial malformation
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital foot malformation
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital pneumonia
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital skin dimples
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Congenital viral hepatitis
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Hooded prepuce
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Naevus flammeus
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Patent ductus arteriosus
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Phimosis
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Polydactyly
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Preauricular cyst
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Supernumerary nipple
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Ventricular septal defect
Congenital, familial and genetic disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Meconium aspiration syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Choking
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal respiratory depression
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Tachypnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Transient tachypnoea of the newborn
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Foetal distress syndrome
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0019 events9 affected75 at risk
EG0026 events6 affected68 at risk
EG003
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected70 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Prolonged labour
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected75 at risk
EG0023 events3 affected68 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0013 events3 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Oligohydramnios
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Premature labour
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0022 events2 affected68 at risk
EG003
Obstructed labour
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Premature delivery
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Arrested labour
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Breech presentation
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Foetal cardiac disorder
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Prolonged rupture of membranes
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Stillbirth
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Umbilical cord compression
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Premature baby
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Jaundice neonatal
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Low birth weight baby
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Meconium ileus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Amniotic cavity infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Mastitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Breast abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Neonatal pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Bacterial sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Sepsis neonatal
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cholestasis of pregnancy
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Hyperbilirubinaemia neonatal
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Neonatal cholestasis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Haemangioma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Infantile haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cardiac murmur
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Pelvi-ureteric obstruction
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Dacryostenosis acquired
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Anaemia neonatal
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cyst
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00018 events18 affected70 at risk
EG00117 events17 affected75 at risk
EG0029 events9 affected68 at risk
EG0030 events0 affected0 at risk
EG0040 events0 affected0 at risk
EG0050 events0 affected0 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0009 events9 affected70 at risk
EG00118 events17 affected75 at risk
EG0029 events7 affected68 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG00011 events11 affected70 at risk
EG00113 events13 affected75 at risk
EG0029 events9 affected68 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0005 events5 affected70 at risk
EG0017 events7 affected75 at risk
EG0024 events4 affected68 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Mouth cyst
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Teething
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Headache
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG00025 events25 affected70 at risk
EG00123 events21 affected75 at risk
EG00214 events14 affected68 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Migraine
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0024 events4 affected68 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0011 events1 affected75 at risk
EG0022 events2 affected68 at risk
EG003
Influenza
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0013 events3 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Beta haemolytic streptococcal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0013 events3 affected75 at risk
EG0022 events2 affected68 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0013 events3 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Ligament pain
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Foetal hypokinesia
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Injection site pain
General disorders
MedDRA 24.0
Systematic Assessment
EG00040 events40 affected70 at risk
EG00139 events39 affected75 at risk
EG00210 events10 affected68 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG00028 events28 affected70 at risk
EG00128 events26 affected75 at risk
EG00217 events17 affected68 at risk
EG003
Injection site erythema
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0015 events5 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Injection site swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected70 at risk
EG0013 events3 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Oedema peripheral
General disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Influenza like illness
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Feeling hot
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Induration
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Injection site irritation
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Swelling
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Uterine contractions during pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0012 events2 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Gestational diabetes
Pregnancy, puerperium and perinatal conditions
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Depression
Psychiatric disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Cholestasis of pregnancy
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Glycosuria
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0010 events0 affected75 at risk
EG0021 events1 affected68 at risk
EG003
Vision blurred
Eye disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected70 at risk
EG0010 events0 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Anaemia of pregnancy
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected70 at risk
EG0011 events1 affected75 at risk
EG0020 events0 affected68 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.