A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers


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  • Number of subjects with solicited local adverse events (AEs) [ Time Frame: During a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days) ]

    Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

  • Number of subjects with solicited general AEs [ Time Frame: During the 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days) ]

    Assessed solicited general symptoms are fatigue, fever [defined as oral/axillary/tympanic route temperature equal to or above 37.5 degrees Celsius (°C) or ≥ 38 °C for rectal route], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevents normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination

  • Number of subjects with unsolicited AEs [ Time Frame: During a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days) ]

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of subjects with haematological abnormalities [ Time Frame: At Day 0 ]

    Haematological laboratory abnormalities include haemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.

  • Number of subjects with haematological abnormalities [ Time Frame: At Day 7 ]

    Haematological laboratory abnormalities include haemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.

  • Number of subjects with biochemical abnormalities [ Time Frame: At Day 0 ]

    Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.

  • Number of subjects with biochemical abnormalities [ Time Frame: At Day 7 ]

    Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.

  • Number of subjects with any serious adverse events (SAEs) [ Time Frame: From study start (Day 0) up to 6 months after delivery ]

    SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of infant subjects with any SAEs [ Time Frame: From birth up to 6 months after birth ]

    SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of subjects with pregnancy outcomes [ Time Frame: From study start (Day 0) up to delivery ]

    Pregnancy outcomes include live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth with no congenital anomalies, foetal death/still birth with congenital anomalies, elective/therapeutic termination with no congenital anomalies and elective/therapeutic termination with congenital anomalies.

  • Number of subjects with pregnancy-related AEs of specific interest [ Time Frame: From study start (Day 0) up to delivery ]

    Pregnancy-related adverse events of specific interest include: gestational diabetes, gestational liver disease (including obstetric cholestasis and acute fatty liver of pregnancy), chorioammionitis, labour protraction and arrest disorders, maternal sepsis, pregnancy-related hypertension, preterm premature rupture of membranes, premature labour, intrauterine growth restriction/poor foetal growth, pre-eclampsia and eclampsia, vaginal or intrauterine haemorrhage, medical conditions necessitating early delivery (induced labour or urgent C-section) (placenta abruption, uterine infection, oligohydramnios, etc), maternal death.

  • Number of infant subjects with AEs of specific interest [ Time Frame: From birth up to 6 months after birth ]

    Infant-related AEs of specific interest include preterm birth, neonatal death, low birth weight and/or small for gestational age, neonatal sepsis, foetal/perinatal distress or asphyxia, failure to thrive/growth deficiency, congenital anomalies and neurodevelopmental delay.