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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSV MAT 60 µg; Biological: RSV MAT 120 µg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • GSK Investigational Site
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • GSK Investigational Site
• Canada
  • Québec, Canada, G1V 4G2
    • GSK Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00290
    • GSK Investigational Site
• France
  • Clermont Ferrand, France, 63100
    • GSK Investigational Site
  • Saint Etienne Cedex 02, France, 42055
    • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 1010
    • GSK Investigational Site
  • Wellington, New Zealand, 6021
    • GSK Investigational Site
• Panama
  • Panama, Panama, 0801
    • GSK Investigational Site
  • Panama City, Panama, 32401
    • GSK Investigational Site
• South Africa
  • Gauteng
    • Soweto, Gauteng, South Africa, 2013
      • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Burgos, Spain, 09006
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Majadahonda (Madrid), Spain, 28222
    • GSK Investigational Site
  • Marbella, Spain, 29600
    • GSK Investigational Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29004
      • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • GSK Investigational Site
  • California
    • Huntington Park, California, United States, 90255
      • GSK Investigational Site
    • Los Angeles, California, United States, 90057
      • GSK Investigational Site
  • Idaho
    • Nampa, Idaho, United States, 83687
      • GSK Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • GSK Investigational Site
  • Mississippi
    • Gulfport, Mississippi, United States, 39503
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • GSK Investigational Site
  • New York
    • Johnson City, New York, United States, 13790
      • GSK Investigational Site
  • Ohio
    • Englewood, Ohio, United States, 45322
      • GSK Investigational Site
  • Texas
    • Beaumont, Texas, United States, 77702
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Plano, Texas, United States, 75093
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
• Child in care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV MAT 60 Group-Mother; Maternal subjects randomized to RSV MAT 60 Group received a single dose of RSV MAT (60 µg) vaccine at Day 1, and were followed up until the study end.	Biological: RSV MAT 60 µg; One single dose of RSV MAT 60 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Experimental: RSV MAT 120 Group-Mother; Maternal subjects randomized to RSV MAT 120 group received a single dose of RSV MAT (120 µg) vaccine at Day 1, and were followed up until the study end.	Biological: RSV MAT 120 µg; One single dose of RSV MAT 120 µg vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Placebo Comparator: Control Group-Mother; Maternal subjects randomized to the Control Group received a single dose of Placebo at Day 1, and were followed up until the study end.	Drug: Placebo; One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
No Intervention: RSV MAT 60 Group-Infant; This group consisted of infants born to mothers (from RSV MAT 60 Group-Mother) who received a single dose of RSV MAT (60 µg) vaccine during pregnancy.
No Intervention: RSV MAT 120 Group-Infant; This group consisted of infants born to mothers (from RSV MAT 120 Group-Mother) who received a single dose of RSV MAT (120 µg) vaccine during pregnancy.
No Intervention: Control Group-Infant; This group consisted of infants born to mothers (from Control Group-Mother) who received a single dose of placebo during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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)	Pregnancy-related AESIs were: Non-Reassuring Fetal Status, Hypertensive Disorders of Pregnancy (HDP), Oligohydramnios, Pathways to Preterm Birth (PPB), Chorioamnionitis, Fetal Growth Restriction, Gestational Liver Disease (GLD), Postpartum Haemorrhage and Gestational Diabetes Mellitus.	From Day 1 to Day 43 post-delivery
Percentage of Infant Subjects With Neonatal AESIs	Neonatal AESIs, reported up to 6 weeks after birth were: Respiratory Distress In The Neonate, Macrosomia, Low Birth Weight, Small For Gestational Age, Preterm Birth, Large For Gestational Age, Neonatal Invasive Blood Stream Infections (NIBSI) and Congenital Anomalies (CA).	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)

Secondary Outcome Measures

Outcome Measure	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.	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.	At Day 181 after birth

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): July 23, 2020
• Study Completion (Actual): May 14, 2021

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 209544; 2019-001991-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No