Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04126213




Registration number
NCT04126213
Ethics application status
Date submitted
11/10/2019
Date registered
15/10/2019
Date last updated
11/06/2020

Titles & IDs
Public title
Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants
Scientific title
A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers
Secondary ID [1] 0 0
2019-001991-12
Secondary ID [2] 0 0
209544
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSVPreF3 formulation 2
Other interventions - RSVPreF3 formulation 3
Treatment: Drugs - Placebo

Experimental: RSV MAT formulation 2 Group - Maternal subjects randomized to RSV MAT formulation 2 Group will receive a single dose of RSVPreF3 formulation 2 vaccine in the deltoid region of the non-dominant arm and will be followed up until the study end.

Experimental: RSV MAT formulation 3 Group - Maternal subjects randomized to RSV MAT formulation 3 group will receive a single dose of RSVPreF3 formulation 3 vaccine in the deltoid region of the non-dominant arm and will be followed up until the study end.

Placebo Comparator: Control Group - Maternal subjects randomized to the Control Group will receive a single dose of Placebo in the deltoid region of the non-dominant arm and will be followed up until the study end.


Other interventions: RSVPreF3 formulation 2
One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Other interventions: RSVPreF3 formulation 3
One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

Treatment: Drugs: Placebo
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of maternal subjects reporting solicited administration site events - An AE is any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Solicited administration site events are: pain, redness and swelling.
Timepoint [1] 0 0
From Day 1 to day 7
Primary outcome [2] 0 0
Percentage of maternal subjects reporting solicited systemic events - Solicited systemic events are: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.
Timepoint [2] 0 0
From Day 1 to day 7
Primary outcome [3] 0 0
Percentage of maternal subjects with hematological and biochemical laboratory abnormality at baseline - The hematological assays are: Complete Blood Count (CBC) with differential and platelet count. The biochemical assays are: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), creatinine and blood urea nitrogen.
Timepoint [3] 0 0
At baseline (Day -15)
Primary outcome [4] 0 0
Percentage of maternal subjects with hematological and biochemical laboratory abnormality at Day 8 - The hematological assays are: Complete Blood Count (CBC) with differential and platelet count. The biochemical assays are: alanine amino-transferase Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), creatinine and blood urea nitrogen.
Timepoint [4] 0 0
At Day 8 (visit 2)
Primary outcome [5] 0 0
Percentage of maternal subjects with unsolicited adverse events (AEs) - An 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.
Timepoint [5] 0 0
From Day 1 to Day 30
Primary outcome [6] 0 0
Percentage of maternal subjects with at least one serious adverse event (SAE) - An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is 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).
Timepoint [6] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [8] 0 0
Percentage of maternal subjects with at least one medically attended AE (MAE) - An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Timepoint [8] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [9] 0 0
Percentage of maternal subjects with pregnancy outcomes - Pregnancy outcomes include live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth (antepartum or intrapartum) with no congenital anomalies, foetal death/still birth (antepartum or intrapartum) with congenital anomalies, elective/therapeutic termination with no congenital anomalies and elective/therapeutic termination with congenital anomalies.
Timepoint [9] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [10] 0 0
Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs) - Pregnancy-related AESIs include maternal death, hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia), antenatal bleeding (morbidly adherent placenta, placental abruption, caesarean scar pregnancy, uterine rupture), postpartum hemorrhage, foetal growth restriction, gestational diabetes mellitus, non-reassuring foetal status, pathways to preterm birth (premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth), chorioamnionitis, oligohydramnios, polyhydramnios, gestational liver disease (intrahepatic cholestasis of pregnancy, acute fatty liver of pregnancy), maternal sepsis.
Timepoint [10] 0 0
From Day 1 to Day 43 post-delivery
Primary outcome [11] 0 0
Percentage of infant subjects with neonatal AESIs - Neonatal AESIs, reported up to 6 weeks after birth, include small for gestational age, low birth weight including very low birth weight, neonatal encephalopathy, congenital microcephaly (postnatally or prenatally diagnosed), congenital anomalies (major external structural defects, internal structural defects, functional defects), neonatal death (in a preterm live birth or in a term live birth), neonatal infections (blood stream infections, meningitis, respiratory infection), respiratory distress in the neonate, preterm birth, failure to thrive, large for gestational age, macrosomia.
Timepoint [11] 0 0
From birth to Day 43 post-birth
Primary outcome [12] 0 0
Percentage of infant subjects with at least one SAE - An 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 subject.
Timepoint [12] 0 0
From birth to Day 43 post-birth
Primary outcome [13] 0 0
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.
Timepoint [13] 0 0
From birth to Day 43 post-birth
Primary outcome [14] 0 0
Percentage of infant subjects with at least one MAE - A MAE is an AE that needs medical supervision.
Timepoint [14] 0 0
From birth to Day 43 post-birth
Primary outcome [15] 0 0
RSVPreF3 Immunoglobulin G (IgG)-specific antibody concentration in terms of Geometric Mean Concentrations (GMCs) at Day 1, before vaccination for each group and by age category - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by Enzyme-linked immunosorbent assay (ELISA). The corresponding antibody concentration is expressed in ELISA units per milliliter (ELU/mL). The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [15] 0 0
At Day 1 (before vaccination)
Primary outcome [16] 0 0
RSVPreF3 IgG antibody GMCs at Day 31 - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [16] 0 0
At Day 31
Primary outcome [17] 0 0
RSVPreF3 IgG antibody GMCs at delivery - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [17] 0 0
At delivery(Visit 5)
Primary outcome [18] 0 0
RSV-A neutralizing antibody Geometric Mean Titers (GMTs) at Day 1, before vaccination - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [18] 0 0
At Day 1 (before vaccination)
Primary outcome [19] 0 0
RSV-A neutralizing antibody GMTs at Day 31 - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [19] 0 0
At Day 31
Primary outcome [20] 0 0
RSV-A neutralizing antibody GMTs at delivery - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The assay is performed for each group and for each age category (18 -<35 years; = 35 years; overall)
Timepoint [20] 0 0
At delivery (Visit 5)
Primary outcome [21] 0 0
RSVPreF3 IgG antibody GMCs in infants born to maternal subjects - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL. The antibodies are 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 can be obtained).
Timepoint [21] 0 0
At birth (Visit Day 1 for infants)
Primary outcome [22] 0 0
RSV-A neutralizing antibody GMTs in infants born to maternal subjects - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The antibodies are 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 can be obtained).
Timepoint [22] 0 0
At birth (Visit Day 1 for infants)
Primary outcome [23] 0 0
Geometric Mean Ratio between cord blood and maternal RSVPreF3 IgG-specific antibody concentrations - The placental transfer ratio is determined between cord blood or an infant blood sample collected within 3 days after birth (if no cord blood sample can be obtained) and maternal RSVPreF3 IgG-specific antibody concentrations. Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA.
Timepoint [23] 0 0
At delivery (visit 5 for maternal subjects) or birth (visit Day 1 for infants)
Secondary outcome [1] 0 0
Percentage of maternal subjects with at least one SAE - An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is 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).
Timepoint [1] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [2] 0 0
Percentage of maternal subjects with at least one MAE - An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Timepoint [2] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [3] 0 0
Percentage of maternal subjects with at least one AE 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.
Timepoint [3] 0 0
From Day 1 to Day 181 post-delivery
Secondary outcome [4] 0 0
Percentage of infant subjects with at least one SAE from birth through 6 months after birth - An 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 subject.
Timepoint [4] 0 0
From birth to Day 181 post-birth
Secondary outcome [5] 0 0
Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 6 months after 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.
Timepoint [5] 0 0
From birth to Day 181 post-birth
Secondary outcome [6] 0 0
Percentage of infant subjects with at least one MAE from birth through 6 months after birth - An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Timepoint [6] 0 0
From birth to Day 181 post-birth
Secondary outcome [7] 0 0
Percentage of infant subjects with at least one SAE from birth through 1 year after birth - An 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 subject.
Timepoint [7] 0 0
From birth to Month 12 post-birth
Secondary outcome [8] 0 0
Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 1 year after 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.
Timepoint [8] 0 0
From birth to Month 12 post-birth
Secondary outcome [9] 0 0
Percentage of infant subjects with at least one MAE from birth through 1 year after birth - A MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Timepoint [9] 0 0
From birth to Month 12 post-birth
Secondary outcome [10] 0 0
Percentage of maternal subjects with at least one RSV-associated Medically Attended RSV-associated 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.
Timepoint [10] 0 0
From delivery (visit 5) to Day 181 post-delivery
Secondary outcome [11] 0 0
Percentage of infant subjects with at least one RSV-associated LRTI - An RSV-associated LRTI is characterised by a history of cough or difficulty in breathing, a blood oxygen saturation by pulse oximetry (SpO2) < 95% or respiratory rate increase and a confirmed RSV infection.
Timepoint [11] 0 0
From birth (Visit at Day 1) to Day 181 post-birth
Secondary outcome [12] 0 0
Percentage of infant subjects with at least one 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.
Timepoint [12] 0 0
From birth (Visit Day 1) to Day 181 post-birth
Secondary outcome [13] 0 0
Percentage of infant subjects with at least one 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.
Timepoint [13] 0 0
From birth (Visit Day 1) to Day 181 post-birth
Secondary outcome [14] 0 0
Percentage of infant subjects with at least one RSV-associated hospitalisation - An RSV-associated hospitalization is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
Timepoint [14] 0 0
From birth (Visit Day 1) to Day 181 post-birth
Secondary outcome [15] 0 0
RSVPreF3 IgG antibody GMCs in maternal subjects, at day 43 - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Timepoint [15] 0 0
At Day 43 post-delivery
Secondary outcome [16] 0 0
RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
Timepoint [16] 0 0
At Day 43 post-delivery
Secondary outcome [17] 0 0
RSV-B neutralizing antibody GMTs in maternal subjects at Day 1 - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay.
Timepoint [17] 0 0
At Day 1 (before vaccination)
Secondary outcome [18] 0 0
RSV-B neutralizing antibody GMTs in maternal subjects at Day 31 - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [18] 0 0
At Day 31
Secondary outcome [19] 0 0
RSV-B neutralizing antibody GMTs in maternal subjects at delivery - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [19] 0 0
At delivery (Visit 5)
Secondary outcome [20] 0 0
RSV-B neutralizing antibody GMTs in maternal subjects at Day 43 post-delivery - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [20] 0 0
At Day 43 post-delivery
Secondary outcome [21] 0 0
RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Timepoint [21] 0 0
At Day 43 after birth
Secondary outcome [22] 0 0
RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Timepoint [22] 0 0
At Day 121 after birth
Secondary outcome [23] 0 0
RSVPreF3 IgG antibody concentration at Day 181 after birth - Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Timepoint [23] 0 0
At Day 181 after birth
Secondary outcome [24] 0 0
RSV-A neutralizing antibody GMTs at Day 43 after birth - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [24] 0 0
At Day 43 after birth
Secondary outcome [25] 0 0
RSV-A neutralizing antibody GMTs at Day 121 after birth - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [25] 0 0
At Day 121 after birth
Secondary outcome [26] 0 0
RSV-A neutralizing antibody GMTs at Day 181 after birth - Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [26] 0 0
At Day 181 after birth
Secondary outcome [27] 0 0
RSV-B neutralizing antibody GMTs at birth - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU. The antibodies are 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 can be obtained).
Timepoint [27] 0 0
At birth (Visit at Day 1)
Secondary outcome [28] 0 0
RSV-B neutralizing antibody GMTs at Day 43 after birth - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [28] 0 0
At Day 43 after birth
Secondary outcome [29] 0 0
RSV-B neutralizing antibody GMTs at Day 121 after birth - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [29] 0 0
At Day 121 after birth
Secondary outcome [30] 0 0
RSV-B neutralizing antibody GMTs at Day 181 after birth - Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers are expressed in ED60 and/or IU.
Timepoint [30] 0 0
At Day 181 after birth

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2021
Actual
Sample size
Target
Accrual to date
Final
385
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [2] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Nova Scotia
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Canada
State/province [13] 0 0
Québec
Country [14] 0 0
Finland
State/province [14] 0 0
Helsinki
Country [15] 0 0
France
State/province [15] 0 0
Clermont Ferrand
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Saint Etienne Cedex 02
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
New Zealand
State/province [20] 0 0
Wellington
Country [21] 0 0
Panama
State/province [21] 0 0
Panama City
Country [22] 0 0
Panama
State/province [22] 0 0
Panama
Country [23] 0 0
South Africa
State/province [23] 0 0
Gauteng
Country [24] 0 0
Spain
State/province [24] 0 0
Andalucia
Country [25] 0 0
Spain
State/province [25] 0 0
Badalona
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona
Country [27] 0 0
Spain
State/province [27] 0 0
Burgos
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
Majadahonda (Madrid)
Country [30] 0 0
Spain
State/province [30] 0 0
Marbella
Country [31] 0 0
Spain
State/province [31] 0 0
Santiago
Country [32] 0 0
Spain
State/province [32] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is 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.
Trial website
https://clinicaltrials.gov/show/NCT04126213
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications