Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126213
Recruitment Status : Not yet recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: RSVPreF3 formulation 2 Biological: RSVPreF3 formulation 3 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Data will be collected in an observer-blind manner. In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the intervention assignment. The laboratory in charge of the sample testing will be blinded to the intervention assignment, codes will be used to link the subject and study (without any link to the intervention attributed to the subject) to each sample. Investigators will remain blinded to each subject's assigned study intervention throughout the course of the study.
Primary Purpose: Prevention
Official Title: A Phase II Observer-blind Study to Assess Safety, Reactogenicity, and Immunogenicity of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
Estimated Study Start Date : November 4, 2019
Estimated Primary Completion Date : July 7, 2020
Estimated Study Completion Date : June 6, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: RSVPreF3 formulation 2
One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.

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

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.
Drug: Placebo
One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.




Primary Outcome Measures :
  1. Percentage of maternal subjects reporting solicited administration site events [ Time Frame: From Day 1 to day 7 ]
    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.

  2. Percentage of maternal subjects reporting solicited systemic events [ Time Frame: From Day 1 to day 7 ]
    Solicited systemic events are: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.

  3. Percentage of maternal subjects with hematological and biochemical laboratory abnormality at baseline [ Time Frame: At baseline (Day -15) ]
    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.

  4. Percentage of maternal subjects with hematological and biochemical laboratory abnormality at Day 8 [ Time Frame: At Day 8 (visit 2) ]
    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.

  5. Percentage of maternal subjects with unsolicited adverse events (AEs) [ Time Frame: From Day 1 to Day 30 ]
    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.

  6. Percentage of maternal subjects with at least one serious adverse event (SAE) [ Time Frame: From Day 1 to Day 43 post-delivery ]
    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).

  7. Percentage of maternal subjects with AEs leading to study withdrawal [ Time Frame: From Day 1 to Day 43 post-delivery ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  8. Percentage of maternal subjects with at least one medically attended AE (MAE) [ Time Frame: From Day 1 to Day 43 post-delivery ]
    An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

  9. Percentage of maternal subjects with pregnancy outcomes [ Time Frame: From Day 1 to Day 43 post-delivery ]
    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.

  10. Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs) [ Time Frame: From Day 1 to Day 43 post-delivery ]
    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.

  11. Percentage of infant subjects with neonatal AESIs [ Time Frame: From birth to Day 43 post-birth ]
    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.

  12. Percentage of infant subjects with at least one SAE [ Time Frame: From birth to Day 43 post-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.

  13. Percentage of infant subjects with AEs leading to study withdrawal [ Time Frame: From birth to Day 43 post-birth ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  14. Percentage of infant subjects with at least one MAE [ Time Frame: From birth to Day 43 post-birth ]
    A MAE is an AE that needs medical supervision.

  15. 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 [ Time Frame: At Day 1 (before vaccination) ]
    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)

  16. RSVPreF3 IgG antibody GMCs at Day 31 [ Time Frame: 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)

  17. RSVPreF3 IgG antibody GMCs at delivery [ Time Frame: At delivery(Visit 5) ]
    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)

  18. RSV-A neutralizing antibody Geometric Mean Titers (GMTs) at Day 1, before vaccination [ Time Frame: 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)

  19. RSV-A neutralizing antibody GMTs at Day 31 [ Time Frame: 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)

  20. RSV-A neutralizing antibody GMTs at delivery [ Time Frame: At delivery (Visit 5) ]
    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)

  21. RSVPreF3 IgG antibody GMCs in infants born to maternal subjects [ Time Frame: At birth (Visit Day 1 for infants) ]
    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).

  22. RSV-A neutralizing antibody GMTs in infants born to maternal subjects [ Time Frame: At birth (Visit Day 1 for infants) ]
    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).

  23. Geometric Mean Ratio between cord blood and maternal RSVPreF3 IgG-specific antibody concentrations [ Time Frame: At delivery (visit 5 for maternal subjects) or birth (visit Day 1 for infants) ]
    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.


Secondary Outcome Measures :
  1. Percentage of maternal subjects with at least one SAE [ Time Frame: From Day 1 to Day 181 post-delivery ]
    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).

  2. Percentage of maternal subjects with at least one MAE [ Time Frame: From Day 1 to Day 181 post-delivery ]
    An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

  3. Percentage of maternal subjects with at least one AE leading to study withdrawal [ Time Frame: From Day 1 to Day 181 post-delivery ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  4. Percentage of infant subjects with at least one SAE from birth through 6 months after birth [ Time Frame: From birth to Day 181 post-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.

  5. Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 6 months after birth [ Time Frame: From birth to Day 181 post-birth ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  6. Percentage of infant subjects with at least one MAE from birth through 6 months after birth [ Time Frame: From birth to Day 181 post-birth ]
    An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

  7. Percentage of infant subjects with at least one SAE from birth through 1 year after birth [ Time Frame: From birth to Month 12 post-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.

  8. Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 1 year after birth [ Time Frame: From birth to Month 12 post-birth ]
    An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  9. Percentage of infant subjects with at least one MAE from birth through 1 year after birth [ Time Frame: From birth to Month 12 post-birth ]
    A MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.

  10. Percentage of maternal subjects with at least one RSV-associated Medically Attended RSV-associated Respiratory Tract Illnesses (MA-RTI) [ Time Frame: From delivery (visit 5) to Day 181 post-delivery ]
    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.

  11. Percentage of infant subjects with at least one RSV-associated LRTI [ Time Frame: From birth (Visit at Day 1) to Day 181 post-birth ]
    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.

  12. Percentage of infant subjects with at least one RSV-associated severe LRTI [ Time Frame: From birth (Visit Day 1) to Day 181 post-birth ]
    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.

  13. Percentage of infant subjects with at least one RSV-associated very severe LRTI [ Time Frame: From birth (Visit Day 1) to Day 181 post-birth ]
    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.

  14. Percentage of infant subjects with at least one RSV-associated hospitalisation [ Time Frame: From birth (Visit Day 1) to Day 181 post-birth ]
    An RSV-associated hospitalization is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.

  15. RSVPreF3 IgG antibody GMCs in maternal subjects, at day 43 [ Time Frame: At Day 43 post-delivery ]
    Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.

  16. RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 [ Time Frame: At Day 43 post-delivery ]
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.

  17. RSV-B neutralizing antibody GMTs in maternal subjects at Day 1 [ Time Frame: At Day 1 (before vaccination) ]
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay.

  18. RSV-B neutralizing antibody GMTs in maternal subjects at Day 31 [ Time Frame: 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.

  19. RSV-B neutralizing antibody GMTs in maternal subjects at delivery [ Time Frame: At delivery (Visit 5) ]
    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.

  20. RSV-B neutralizing antibody GMTs in maternal subjects at Day 43 post-delivery [ Time Frame: 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.

  21. RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth [ Time Frame: 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.

  22. RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth [ Time Frame: 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.

  23. RSVPreF3 IgG antibody concentration at Day 181 after birth [ Time Frame: 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.

  24. RSV-A neutralizing antibody GMTs at Day 43 after birth [ Time Frame: 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.

  25. RSV-A neutralizing antibody GMTs at Day 121 after birth [ Time Frame: 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.

  26. RSV-A neutralizing antibody GMTs at Day 181 after birth [ Time Frame: 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.

  27. RSV-B neutralizing antibody GMTs at birth [ Time Frame: At birth (Visit at Day 1) ]
    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).

  28. RSV-B neutralizing antibody GMTs at Day 43 after birth [ Time Frame: 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.

  29. RSV-B neutralizing antibody GMTs at Day 121 after birth [ Time Frame: 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.

  30. RSV-B neutralizing antibody GMTs at Day 181 after birth [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Maternal subjects

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Subjects who give written or witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before performing any study specific procedure.

    • The informed consent given at screening should either include consent for both the mother's participation and participation of the infant after the infant's birth, or consent for the mother's participation and expressed willingness to consider permitting the infant to take part after the infant has been born.
    • 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 II ultrasound conducted after 18 weeks of gestation
  • Willing to provide cord blood
  • Willing to have the infant followed-up after delivery for a period of 12 months
  • Does not plan after delivery to give the infant for adoption or place the infant in care Note that women whose pregnancies resulted from Assisted Reproductive Technologies may be enrolled if they meet all inclusion criteria and none of the exclusion criteria.

Infant subjects

  • Live-born from the study pregnancy.
  • Re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or legally authorized representative, as applicable by local law, before performing any study specific procedure.

Exclusion Criteria:

Maternal subjects

Medical conditions

  • History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
  • Hypersensitivity to latex
  • Significant complications in the current pregnancy such as:

    • Gestational hypertension at ≥20 weeks of gestation in the absence of proteinuria in a woman with a previously normal blood pressure
    • Gestational diabetes which is not controlled by diet and exercise
    • Pre-eclampsia
    • Eclampsia during current pregnancy
    • Intrauterine growth restriction
    • Placenta previa
    • Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that in the opinion of Investigator can impair the maternal-fetal circulation
    • Polyhydramnios
    • Oligohydramnios
    • Cervical suture in place
    • Preterm labour or history of preterm labour in the current pregnancy
    • Ongoing medical intervention to prevent preterm delivery or medical treatment for suspected preterm delivery
    • Cholestasis
    • Other pregnancy-related complications that in the Investigator's judgement would preclude participation of the subjects in an investigational vaccine trial or might pose risk to the subject due to participation in the study
  • Significant structural abnormalities of the uterus or cervix
  • History of prior stillbirth or neonatal death
  • History of preterm birth
  • History of ≥2 spontaneous abortions
  • Known or suspected HBV or HCV infection, based on medical history and clinical presentation
  • Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex, based on medical history and clinical presentation
  • Active infection with tuberculosis, based on medical history and clinical presentation
  • Known or suspected impairment of the immune system or autoimmune disorder within 6 months before vaccination
  • 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

  • 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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126213


Contacts
Layout table for location contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04126213     History of Changes
Other Study ID Numbers: 209544
2019-001991-12 ( EudraCT Number )
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs