Covid 19 Research using Clinical Trials (Home Page)
RSVPreF3 formulation 3Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2008 | RSVPreF3 formulation 2 Wiki | 1.00 |
| drug1822 | Placebo Wiki | 0.06 |
Correlated MeSH Terms (1)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D018357 | Respiratory Syncytial Virus Infections NIH | 0.41 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers
The purpose of this study 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.
NCT04126213 Respiratory Syncytial Virus Infections Biological: RSVPreF3 formulation 2 Biological: RSVPreF3 formulation 3 Drug: Placebo MeSH:Respiratory Syncytial Virus Infections
Primary Outcomes
Description: 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.
Measure: Percentage of maternal subjects reporting solicited administration site events Time: From Day 1 to day 7Description: Solicited systemic events are: fatigue, fever, nausea, vomiting, diarrhea, abdominal pain and headache.
Measure: Percentage of maternal subjects reporting solicited systemic events Time: From Day 1 to day 7Description: 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.
Measure: Percentage of maternal subjects with hematological and biochemical laboratory abnormality at baseline Time: At baseline (Day -15)Description: 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.
Measure: Percentage of maternal subjects with hematological and biochemical laboratory abnormality at Day 8 Time: At Day 8 (visit 2)Description: 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.
Measure: Percentage of maternal subjects with unsolicited adverse events (AEs) Time: From Day 1 to Day 30Description: 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).
Measure: Percentage of maternal subjects with at least one serious adverse event (SAE) Time: From Day 1 to Day 43 post-deliveryDescription: 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.
Measure: Percentage of maternal subjects with AEs leading to study withdrawal Time: From Day 1 to Day 43 post-deliveryDescription: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Measure: Percentage of maternal subjects with at least one medically attended AE (MAE) Time: From Day 1 to Day 43 post-deliveryDescription: 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.
Measure: Percentage of maternal subjects with pregnancy outcomes Time: From Day 1 to Day 43 post-deliveryDescription: 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.
Measure: Percentage of maternal subjects with pregnancy-related Adverse Events of Special Interest (AESIs) Time: From Day 1 to Day 43 post-deliveryDescription: 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.
Measure: Percentage of infant subjects with neonatal AESIs Time: From birth to Day 43 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one SAE Time: From birth to Day 43 post-birthDescription: 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.
Measure: Percentage of infant subjects with AEs leading to study withdrawal Time: From birth to Day 43 post-birthDescription: A MAE is an AE that needs medical supervision.
Measure: Percentage of infant subjects with at least one MAE Time: From birth to Day 43 post-birthDescription: 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)
Measure: 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: At Day 1 (before vaccination)Description: 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)
Measure: RSVPreF3 IgG antibody GMCs at Day 31 Time: At Day 31Description: 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)
Measure: RSVPreF3 IgG antibody GMCs at delivery Time: At delivery(Visit 5)Description: 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)
Measure: RSV-A neutralizing antibody Geometric Mean Titers (GMTs) at Day 1, before vaccination Time: At Day 1 (before vaccination)Description: 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)
Measure: RSV-A neutralizing antibody GMTs at Day 31 Time: At Day 31Description: 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)
Measure: RSV-A neutralizing antibody GMTs at delivery Time: At delivery (Visit 5)Description: 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).
Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects Time: At birth (Visit Day 1 for infants)Description: 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).
Measure: RSV-A neutralizing antibody GMTs in infants born to maternal subjects Time: At birth (Visit Day 1 for infants)Description: 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.
Measure: Geometric Mean Ratio between cord blood and maternal RSVPreF3 IgG-specific antibody concentrations Time: At delivery (visit 5 for maternal subjects) or birth (visit Day 1 for infants)Secondary Outcomes
Description: 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).
Measure: Percentage of maternal subjects with at least one SAE Time: From Day 1 to Day 181 post-deliveryDescription: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Measure: Percentage of maternal subjects with at least one MAE Time: From Day 1 to Day 181 post-deliveryDescription: 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.
Measure: Percentage of maternal subjects with at least one AE leading to study withdrawal Time: From Day 1 to Day 181 post-deliveryDescription: 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.
Measure: Percentage of infant subjects with at least one SAE from birth through 6 months after birth Time: From birth to Day 181 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 6 months after birth Time: From birth to Day 181 post-birthDescription: An MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Measure: Percentage of infant subjects with at least one MAE from birth through 6 months after birth Time: From birth to Day 181 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one SAE from birth through 1 year after birth Time: From birth to Month 12 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 1 year after birth Time: From birth to Month 12 post-birthDescription: A MAE is a symptom or illness requiring hospitalisation, emergency room visit, or visit to/by a health care provider.
Measure: Percentage of infant subjects with at least one MAE from birth through 1 year after birth Time: From birth to Month 12 post-birthDescription: 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.
Measure: Percentage of maternal subjects with at least one RSV-associated Medically Attended RSV-associated Respiratory Tract Illnesses (MA-RTI) Time: From delivery (visit 5) to Day 181 post-deliveryDescription: 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.
Measure: Percentage of infant subjects with at least one RSV-associated LRTI Time: From birth (Visit at Day 1) to Day 181 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one RSV-associated severe LRTI Time: From birth (Visit Day 1) to Day 181 post-birthDescription: 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.
Measure: Percentage of infant subjects with at least one RSV-associated very severe LRTI Time: From birth (Visit Day 1) to Day 181 post-birthDescription: An RSV-associated hospitalization is characterised by a confirmed RSV infection and a hospitalisation for an acute medical condition.
Measure: Percentage of infant subjects with at least one RSV-associated hospitalisation Time: From birth (Visit Day 1) to Day 181 post-birthDescription: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Measure: RSVPreF3 IgG antibody GMCs in maternal subjects, at day 43 Time: At Day 43 post-deliveryDescription: Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay.
Measure: RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 Time: At Day 43 post-deliveryDescription: Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay.
Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 1 Time: At Day 1 (before vaccination)Description: 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.
Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 31 Time: At Day 31Description: 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.
Measure: RSV-B neutralizing antibody GMTs in maternal subjects at delivery Time: At delivery (Visit 5)Description: 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.
Measure: RSV-B neutralizing antibody GMTs in maternal subjects at Day 43 post-delivery Time: At Day 43 post-deliveryDescription: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth Time: At Day 43 after birthDescription: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Measure: RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth Time: At Day 121 after birthDescription: Serological assays for the determination of IgG antibodies against RSVPreF3 are performed by ELISA. The corresponding antibody concentration is expressed in ELU/mL.
Measure: RSVPreF3 IgG antibody concentration at Day 181 after birth Time: At Day 181 after birthDescription: 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.
Measure: RSV-A neutralizing antibody GMTs at Day 43 after birth Time: At Day 43 after birthDescription: 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.
Measure: RSV-A neutralizing antibody GMTs at Day 121 after birth Time: At Day 121 after birthDescription: 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.
Measure: RSV-A neutralizing antibody GMTs at Day 181 after birth Time: At Day 181 after birthDescription: 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).
Measure: RSV-B neutralizing antibody GMTs at birth Time: At birth (Visit at Day 1)Description: 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.
Measure: RSV-B neutralizing antibody GMTs at Day 43 after birth Time: At Day 43 after birthDescription: 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.
Measure: RSV-B neutralizing antibody GMTs at Day 121 after birth Time: At Day 121 after birthDescription: 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.
Measure: RSV-B neutralizing antibody GMTs at Day 181 after birth Time: At Day 181 after birth