Clinical Trials List
Protocol NumberRSV MAT-008 (214753)
NCT Number(ClinicalTrials.gov Identfier)NCT04605159
2022-02-15 - 2024-01-25
Phase III
Recruiting5
ICD-10B97.4
Respiratory syncytial virus as the cause of diseases classified elsewhere
ICD-9079.6
Respiratory syncytial virus(RSV) infections in conditions classified elsewhere and of unspecified site
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
-
Trial Applicant
GlaxoSmithKline
-
Sponsor
GlaxoSmithKline
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jia-Chun Yuan 無
- Jun-Wei Su 無
- Yi-Yan Chen 無
- Tsan-Hung Chiu 無
- 楊稚怡 無
- Min-Min Chou 無
- Pei-Chen Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 翁逸豪 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 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 (IM) 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.
Test Drug
RSV MAT
Active Ingredient
RSV MAT
Dosage Form
IM
Dosage
120
Endpoints
The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) 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.
Inclution Criteria
Maternal participants
Maternal participants must satisfy all the following criteria at study entry:
• Participants who, in the opinion of the investigator, can and will comply with the
requirements of the protocol (e.g. completion of diaries, return for follow-up visits).
• Participants 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 participant’s participation and
participation of the infant after the infant’s birth, or
− include consent for the maternal participant’s participation and expressed
willingness to consider permitting the infant to take part after the infant’s birth
(if local regulations/guidelines require parent(s) to provide an additional
informed consent after the infant’s birth).
− Both mother and father should consent if local regulations/guidelines require it.
• Age 18 to 49 years, inclusive, at the time of study intervention.
• Pre-pregnancy BMI (based on participant’s report) 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.
NOTES: If pregnancy resulted from assisted reproductive technologies, LMP date
may be replaced by IUI (intrauterine insemination) or ET (embryo-transfer) date).
If LMP (or IUI or ET) and U/S performed before 28weeks of gestation, do not
correlate, default to U/S gestational age assessment.
If the first U/S is only performed after 28 weeks of gestation (i.e. 3rd trimester) and
there is no other basis for estimating gestational age, or the only other basis is fundal
height, then the GA calculation is uncertain and the woman should be excluded.
The level of diagnostic certainty of the gestational age should be established by using
the Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)
gestation age assessment tool (Section 10.8).
• No fetal genetic abnormalities (based on genetic testing, if performed).
• No significant congenital malformations (such as abnormal fetal morphology,
abnormal amniotic fluid levels, significant abnormalities in placenta or umbilical
cord), as assessed by fetal anomaly ultrasound scan (also known as a level 2
ultrasound or fetal morphology assessment) 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.
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 participants
Infant participants must satisfy all the following criteria at study entry:
• 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. To comply with RTI surveillance and other protocolrequired procedures that begin immediately after birth: If written consent cannot be
provided by the parent(s)/LAR(s) readily post-birth, verbal consent – if permitted per
local regulation -- may be sought from the parent(s) / LAR(s) instead. Verbal consent
should be documented in the source data by the investigator or delegate. The
parent(s) / LAR(s) will provide additional, written informed consent by (or before)
Visit 2-NB.
Maternal participants must satisfy all the following criteria at study entry:
• Participants who, in the opinion of the investigator, can and will comply with the
requirements of the protocol (e.g. completion of diaries, return for follow-up visits).
• Participants 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 participant’s participation and
participation of the infant after the infant’s birth, or
− include consent for the maternal participant’s participation and expressed
willingness to consider permitting the infant to take part after the infant’s birth
(if local regulations/guidelines require parent(s) to provide an additional
informed consent after the infant’s birth).
− Both mother and father should consent if local regulations/guidelines require it.
• Age 18 to 49 years, inclusive, at the time of study intervention.
• Pre-pregnancy BMI (based on participant’s report) 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.
NOTES: If pregnancy resulted from assisted reproductive technologies, LMP date
may be replaced by IUI (intrauterine insemination) or ET (embryo-transfer) date).
If LMP (or IUI or ET) and U/S performed before 28weeks of gestation, do not
correlate, default to U/S gestational age assessment.
If the first U/S is only performed after 28 weeks of gestation (i.e. 3rd trimester) and
there is no other basis for estimating gestational age, or the only other basis is fundal
height, then the GA calculation is uncertain and the woman should be excluded.
The level of diagnostic certainty of the gestational age should be established by using
the Global Alignment of Immunisation safety Assessment in pregnancy (GAIA)
gestation age assessment tool (Section 10.8).
• No fetal genetic abnormalities (based on genetic testing, if performed).
• No significant congenital malformations (such as abnormal fetal morphology,
abnormal amniotic fluid levels, significant abnormalities in placenta or umbilical
cord), as assessed by fetal anomaly ultrasound scan (also known as a level 2
ultrasound or fetal morphology assessment) 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.
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 participants
Infant participants must satisfy all the following criteria at study entry:
• 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. To comply with RTI surveillance and other protocolrequired procedures that begin immediately after birth: If written consent cannot be
provided by the parent(s)/LAR(s) readily post-birth, verbal consent – if permitted per
local regulation -- may be sought from the parent(s) / LAR(s) instead. Verbal consent
should be documented in the source data by the investigator or delegate. The
parent(s) / LAR(s) will provide additional, written informed consent by (or before)
Visit 2-NB.
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, Hepatitis B vaccines, and COVID-19 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.
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, Hepatitis B vaccines, and COVID-19 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
20 participants
-
Global
353 participants
