Clinical Trials List
Protocol NumberRSV MAT-009(212171)
NCT Number(ClinicalTrials.gov Identfier)NCT04605159
Completed
2021-01-01 - 2024-12-31
Phase III
Recruiting6
Terminated1
A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age
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Trial Applicant
GlaxoSmithKline
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Sponsor
GlaxoSmithKline
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Principal Investigator
Co-Principal Investigator
- Sheng-Wen Shaw 無
- 李彥璋 Division of Obstetrics & Gynecology
- 傅仁煇 Division of Pediatrics
- 李建忠 Division of Pediatrics
- 翁逸豪 Division of Pediatrics
- 闕河晏 Division of Obstetrics & Gynecology
- Cheng-Hsun Chiu Division of Pediatrics
- 江明洲 無
- Jen Fu Hsu Division of Pediatrics
- Yao-Lung Chang 無
- 李汶芳 Division of Obstetrics & Gynecology
- 朱世明 無
- 賴美吟 Division of Pediatrics
- 程劭文 Division of Pediatrics
- 游舒涵 Division of Obstetrics & Gynecology
- 林瑞瑩 Division of Pediatrics
- 楊長佑 Division of Pediatrics
- 許凱翔 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李汶芳 無
- Cheng-Hsun Chiu 無
- 傅仁煇 無
- 賴美吟 無
- 蕭建洲 無
- 李建忠 無
- Jen Fu Hsu 無
- 游舒涵 無
- 闕河晏 無
- 吳琬如 無
- 林瑞瑩 無
- 許凱翔 無
- 楊珮音 無
- Cheng-Han Lee 無
- 李彥璋 無
- Jia-Chun Yuan 無
- 楊長佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Min-Min Chou 無
- Pei-Chen Huang 無
- Ming Ho 無
- Jia-Chun Yuan Division of Obstetrics & Gynecology
- Yi-Yan Chen Division of Obstetrics & Gynecology
- Jun-Wei Su Division of Obstetrics & Gynecology
- Hung-Chih Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Respiratory Syncytial Virus Infections
Objectives
The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.
Test Drug
RSVPreF3 vaccine, placebo
Active Ingredient
Placebo
RSVPreF3 vaccine
RSVPreF3 vaccine
Dosage Form
IM
IM
IM
Dosage
sodium chloride (NaCl) 0.9%
sodium chloride (NaCl) 0.9%
sodium chloride (NaCl) 0.9%
Endpoints
Primary Outcome Measures :
Number of infant participants with medically assessed, RSV-associated LRTIs, up to 6 months of age [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of severe (including very severe) and/or any medically assessed, RSV-associated LRTIs.
Secondary Outcome Measures :
Number of infant participants with RSV-associated hospitalizations [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of RSV associated hospitalizations.
Number of infant participants with all-cause LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs.
Number of infant participants with all-cause LRTIs with hospitalization [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs with hospitalization.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 7 months of age [ Time Frame: From birth to Day 211 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 8 months of age [ Time Frame: From birth to Day 241 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 9 months of age [ Time Frame: From birth to Day 271 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 7 months of age [ Time Frame: From birth to Day 211 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 8 months of age [ Time Frame: From birth to Day 241 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 9 months of age [ Time Frame: From birth to Day 271 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with medically assessed, RSV-associated LRTIs, up to 4 months of age [ Time Frame: From birth to Day 121 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs.
Number of infant participants with medically assessed, RSV LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV LRTIs.
Number of infant participants with all-cause pneumonia [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause pneumonia.
Time to first occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the time to first occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs.
Number of maternal participants with RSV-associated Medically Attended RTIs (RSV-MA-RTIs) [ Time Frame: From Day 1 (vaccination) to Day 181 post delivery ]
The vaccine arm will be compared to the placebo arm through the occurrence of RSV-associated MA-RTIs
Humoral immune response in terms of RSV MAT immunoglobulin G (IgG) antibody Geometric Mean Concentration (GMCs) in maternal participants, at specified timepoints [ Time Frame: Day 1 (pre vaccination), Day 31 and at delivery ]
Serological assays for the determination of IgG antibodies against RSV MAT are performed by Enzyme-Linked Immunosorbent Assay (ELISA).
Humoral immune response in terms of RSV neutralizing antibody Geometric Mean Titers (GMTs) in maternal participants, at specified timepoints [ Time Frame: At Day 1 (pre vaccination), Day 31 and at Delivery ]
Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.
Humoral immune response in terms of RSV MAT IgG antibody GMCs in infant participants, at specified timepoints [ Time Frame: At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth ]
Serological assays for the determination of IgG antibodies against RSV MAT are performed by ELISA.
Humoral immune response in terms of RSV neutralizing antibody GMTs in infant participants, at specified timepoints. [ Time Frame: At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth ]
Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.
Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations [ Time Frame: At delivery or birth ]
Transfer of RSV-specific antibodies from maternal participants vaccinated with RSV Mat to their infants is calculated as the ratio between cord blood* and maternal RSV MAT IgG-specific antibody concentrations. * or an infant blood sample collected within 72 hours after birth (if no cord blood sample can be obtained)
Number of maternal participants with solicited adverse events (AEs) [ Time Frame: From Day 1 to Day 7 ]
Assessed solicited administration site events include pain, redness and swelling, at the injection site. Assessed solicited systemic events include fatigue, fever, nausea, vomiting, diarrhoea, abdominal pain and headache.
Number of maternal participants with unsolicited AEs [ Time Frame: From Day 1 to Day 30 ]
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
Number of maternal participants with at least one serious adverse event (SAE), AE leading to study termination or medically attended respiratory tract illness (MA-RTI) [ Time Frame: From Day 1 (vaccination) to Month 6 post delivery ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. MA-RTI occurs when the maternal participant visits a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing.
Number of maternal participants with at least one other medically attended AE [ Time Frame: From Day 1 (vaccination) to Day 43 post delivery ]
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of maternal participants with each pregnancy outcome [ Time Frame: From Day 1 to Day 43 post delivery ]
These pregnancy outcomes include live birth with no congenital anomalies, live birth with minor congenital anomaly(ies) only; live birth with at least one major congenital anomaly, fetal death/still birth (antepartum or intrapartum) with no congenital anomalies, fetal death/still birth (antepartum or intrapartum) with only minor congenital anomalies, fetal death/still birth (antepartum or intrapartum) with at least 1 major congenital anomaly; elective/therapeutic termination with no congenital anomalies; elective/therapeutic termination with only minor congenital anomalies, and elective/therapeutic termination with at least 1 major congenital anomaly.
Number of maternal participants with each pregnancy-related AE of special interest (AESI) [ Time Frame: From Day 1 (vaccination) to Day 43 post delivery ]
These pregnancy-related AESIs include maternal death, hypertensive disorders of pregnancy, fetal growth restriction, pathways to preterm birth, gestational diabetes mellitus and chorioamnionitis.
Number of infant participants with each neonatal AESI [ Time Frame: From birth to Day 43 post birth ]
Neonatal AESIs include small for gestational age, low birth weight including very low and extremely low birth weight, congenital anomalies, neonatal death, preterm birth.
Number of infant participants with at least one SAE, AE leading to study termination or Medically Attended AEs (MAE), from birth up to 6 months after birth [ Time Frame: From birth to Month 6 post birth ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.
Number of infant participants with at least one SAE, AE leading to study termination or MAE, from birth up to 12 months after birth [ Time Frame: From birth to Month 12 post birth ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.
Number of infant participants with medically assessed, RSV-associated LRTIs, up to 6 months of age [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of severe (including very severe) and/or any medically assessed, RSV-associated LRTIs.
Secondary Outcome Measures :
Number of infant participants with RSV-associated hospitalizations [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of RSV associated hospitalizations.
Number of infant participants with all-cause LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs.
Number of infant participants with all-cause LRTIs with hospitalization [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause LRTIs with hospitalization.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 7 months of age [ Time Frame: From birth to Day 211 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 8 months of age [ Time Frame: From birth to Day 241 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 9 months of age [ Time Frame: From birth to Day 271 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV-associated severe (including very severe) LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 7 months of age [ Time Frame: From birth to Day 211 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 8 months of age [ Time Frame: From birth to Day 241 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 9 months of age [ Time Frame: From birth to Day 271 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of any medically assessed, RSV-associated LRTIs.
Number of infant participants with medically assessed, RSV-associated LRTIs, up to 4 months of age [ Time Frame: From birth to Day 121 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs.
Number of infant participants with medically assessed, RSV LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of medically assessed, RSV LRTIs.
Number of infant participants with all-cause pneumonia [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the occurrence of all-cause pneumonia.
Time to first occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs [ Time Frame: From birth to Day 181 post birth ]
The vaccine arm will be compared to the placebo arm through the time to first occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs.
Number of maternal participants with RSV-associated Medically Attended RTIs (RSV-MA-RTIs) [ Time Frame: From Day 1 (vaccination) to Day 181 post delivery ]
The vaccine arm will be compared to the placebo arm through the occurrence of RSV-associated MA-RTIs
Humoral immune response in terms of RSV MAT immunoglobulin G (IgG) antibody Geometric Mean Concentration (GMCs) in maternal participants, at specified timepoints [ Time Frame: Day 1 (pre vaccination), Day 31 and at delivery ]
Serological assays for the determination of IgG antibodies against RSV MAT are performed by Enzyme-Linked Immunosorbent Assay (ELISA).
Humoral immune response in terms of RSV neutralizing antibody Geometric Mean Titers (GMTs) in maternal participants, at specified timepoints [ Time Frame: At Day 1 (pre vaccination), Day 31 and at Delivery ]
Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.
Humoral immune response in terms of RSV MAT IgG antibody GMCs in infant participants, at specified timepoints [ Time Frame: At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth ]
Serological assays for the determination of IgG antibodies against RSV MAT are performed by ELISA.
Humoral immune response in terms of RSV neutralizing antibody GMTs in infant participants, at specified timepoints. [ Time Frame: At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth ]
Serological assays for the determination of antibodies against RSV-A and B are performed by neutralization assay.
Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations [ Time Frame: At delivery or birth ]
Transfer of RSV-specific antibodies from maternal participants vaccinated with RSV Mat to their infants is calculated as the ratio between cord blood* and maternal RSV MAT IgG-specific antibody concentrations. * or an infant blood sample collected within 72 hours after birth (if no cord blood sample can be obtained)
Number of maternal participants with solicited adverse events (AEs) [ Time Frame: From Day 1 to Day 7 ]
Assessed solicited administration site events include pain, redness and swelling, at the injection site. Assessed solicited systemic events include fatigue, fever, nausea, vomiting, diarrhoea, abdominal pain and headache.
Number of maternal participants with unsolicited AEs [ Time Frame: From Day 1 to Day 30 ]
Any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE.
Number of maternal participants with at least one serious adverse event (SAE), AE leading to study termination or medically attended respiratory tract illness (MA-RTI) [ Time Frame: From Day 1 (vaccination) to Month 6 post delivery ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. MA-RTI occurs when the maternal participant visits a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing.
Number of maternal participants with at least one other medically attended AE [ Time Frame: From Day 1 (vaccination) to Day 43 post delivery ]
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of maternal participants with each pregnancy outcome [ Time Frame: From Day 1 to Day 43 post delivery ]
These pregnancy outcomes include live birth with no congenital anomalies, live birth with minor congenital anomaly(ies) only; live birth with at least one major congenital anomaly, fetal death/still birth (antepartum or intrapartum) with no congenital anomalies, fetal death/still birth (antepartum or intrapartum) with only minor congenital anomalies, fetal death/still birth (antepartum or intrapartum) with at least 1 major congenital anomaly; elective/therapeutic termination with no congenital anomalies; elective/therapeutic termination with only minor congenital anomalies, and elective/therapeutic termination with at least 1 major congenital anomaly.
Number of maternal participants with each pregnancy-related AE of special interest (AESI) [ Time Frame: From Day 1 (vaccination) to Day 43 post delivery ]
These pregnancy-related AESIs include maternal death, hypertensive disorders of pregnancy, fetal growth restriction, pathways to preterm birth, gestational diabetes mellitus and chorioamnionitis.
Number of infant participants with each neonatal AESI [ Time Frame: From birth to Day 43 post birth ]
Neonatal AESIs include small for gestational age, low birth weight including very low and extremely low birth weight, congenital anomalies, neonatal death, preterm birth.
Number of infant participants with at least one SAE, AE leading to study termination or Medically Attended AEs (MAE), from birth up to 6 months after birth [ Time Frame: From birth to Month 6 post birth ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.
Number of infant participants with at least one SAE, AE leading to study termination or MAE, from birth up to 12 months after birth [ Time Frame: From birth to Month 12 post birth ]
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. A MAE is an unsolicited AE such as a symptom or illness which requires a hospitalisation, or emergency room visit, or visit to/by a health care provider.
Inclution Criteria
Inclusion Criteria:
Maternal participants
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.
Age 18 to 49 years, inclusive, at the time of study intervention.
Pre-pregnancy BMI 18.5 to 39.9 kg/m2, inclusive.
In good general maternal health as established by medical history and clinical examination before entering into the study.
Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome).
At 24^0/7 to 34^0/7 weeks of gestation at the time of study vaccination (Visit 1), as established by:
last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
1st or 2nd trimester U/S only, if LMP is unknown/uncertain
Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
No fetal genetic abnormalities (based on genetic testing, if performed).
No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.
Willing to provide cord blood.
Who do not plan to give their child for adoption.
Who plan to reside in the study area for at least one year after delivery.
Willing to have the infant followed-up after delivery for a period of 12 months.
Infant participants
Live-born from the study pregnancy.
If required per local regulations/guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.
Maternal participants
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.
Age 18 to 49 years, inclusive, at the time of study intervention.
Pre-pregnancy BMI 18.5 to 39.9 kg/m2, inclusive.
In good general maternal health as established by medical history and clinical examination before entering into the study.
Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome).
At 24^0/7 to 34^0/7 weeks of gestation at the time of study vaccination (Visit 1), as established by:
last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
1st or 2nd trimester U/S only, if LMP is unknown/uncertain
Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
No fetal genetic abnormalities (based on genetic testing, if performed).
No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.
Willing to provide cord blood.
Who do not plan to give their child for adoption.
Who plan to reside in the study area for at least one year after delivery.
Willing to have the infant followed-up after delivery for a period of 12 months.
Infant participants
Live-born from the study pregnancy.
If required per local regulations/guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.
Exclusion Criteria
Exclusion Criteria:
Maternal participants Medical conditions
History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
Hypersensitivity to latex
Significant complications in the current pregnancy:
Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (<140mmHg and <90mmHg) through diet and/or antihypertensive medications
Gestational diabetes not controlled by medication, diet and/or exercise
Pre-eclampsia
Eclampsia
Intrauterine Growth Restriction/Fetal Growth Restriction
Placenta previa
Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation
Polyhydramnios
Oligohydramnios
Preterm labour or history of preterm labour in the current pregnancy
Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
Cholestasis
Other pregnancy-related complications (per investigator's judgement)
Significant structural abnormalities of the uterus or cervix
History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions
Known HIV infection (as per serological tests performed during the current pregnancy)
Known or suspected HBV or HCV infection
Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex
Active infection with tuberculosis
Known or suspected impairment of the immune system
Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
Lymphoproliferative disorder or malignancy within 5 years before study vaccination
Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care
Any condition which would increase the risks of study participation to the unborn infant
Prior/Concomitant therapy
Prior receipt of an RSV vaccine in the current pregnancy
Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :
For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
For immunoglobulins: 3 months before the dose of study vaccine/product.
The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery
Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, all of which may be administered according to standard of care ≥15 days before or after study vaccination
Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery
Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
Corticosteroids administered for fetal lung maturation
Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
Other exclusions
Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
Consanguinity of maternal participant and her partner (second degree cousins or closer)
Any study personnel or their immediate dependants, family or household members
Infant participants
Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
Any condition which would increase the risks of study participation to the infant
Child in care.
Maternal participants Medical conditions
History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
Hypersensitivity to latex
Significant complications in the current pregnancy:
Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (<140mmHg and <90mmHg) through diet and/or antihypertensive medications
Gestational diabetes not controlled by medication, diet and/or exercise
Pre-eclampsia
Eclampsia
Intrauterine Growth Restriction/Fetal Growth Restriction
Placenta previa
Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation
Polyhydramnios
Oligohydramnios
Preterm labour or history of preterm labour in the current pregnancy
Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
Cholestasis
Other pregnancy-related complications (per investigator's judgement)
Significant structural abnormalities of the uterus or cervix
History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions
Known HIV infection (as per serological tests performed during the current pregnancy)
Known or suspected HBV or HCV infection
Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex
Active infection with tuberculosis
Known or suspected impairment of the immune system
Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
Lymphoproliferative disorder or malignancy within 5 years before study vaccination
Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care
Any condition which would increase the risks of study participation to the unborn infant
Prior/Concomitant therapy
Prior receipt of an RSV vaccine in the current pregnancy
Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :
For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
For immunoglobulins: 3 months before the dose of study vaccine/product.
The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery
Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, all of which may be administered according to standard of care ≥15 days before or after study vaccination
Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery
Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
Corticosteroids administered for fetal lung maturation
Prior/Concurrent clinical study experience
- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
Other exclusions
Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
Consanguinity of maternal participant and her partner (second degree cousins or closer)
Any study personnel or their immediate dependants, family or household members
Infant participants
Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
Any condition which would increase the risks of study participation to the infant
Child in care.
The Estimated Number of Participants
-
Taiwan
170 participants
-
Global
10000 participants
