High risk pregnant women (prevention of RSV-associated lower respiratory tract illnesses (LRTIs) in infants)
Conditions
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Maternal participants • Participants who can and will comply with the requirements of the protocol. • Participants and LARs 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 either: - include consent for both the maternal participant’s participation* and participation of the infant after the infant’s birth, or - include consent for the maternal participant’s participation* and expressed willingness to consider permitting the infant to take part after the infant’s birth (if local regulations/guidelines require parent(s) to provide an additional informed consent after the infant’s birth). - both mother and father should consent if local regulations / guidelines require it. • Pre-pregnancy Body Mass Index (based on participant’s report) 18.5 to 39.9 kg/m^2, inclusive. • Healthy adolescent pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention administration. OR • Pregnant women, 18 to 49 YOA, inclusive, at the time of study intervention administration with: - HIV infection AND/OR - Obstetric complications or risk factors during the current pregnancy, where the expectant management of the pregnancy is possible and without evidence of non-reassuring fetal status (only cases for which fetal heart rate can be ascertained) as follows: - Gestational diabetes, well-controlled on medications (with or without diet or exercise) - Gestational hypertension, well-controlled on diet or medications below 160/110 mmHg. - Pre-eclampsia without severe features (i.e. eclampsia, severe hypertension [>160/110 mmHg], organ dysfunction, unstable or complicated by [HELLP] syndrome). - Fetal Growth Restriction in singleton pregnancies, with normal umbilical artery Doppler and estimated fetal weight 3 to 10th percentile for gestational age. - History of threatened preterm labor in the current pregnancy, with no cervical dilation greater than 2 cm or effacement exceeding 50%, and/or no progressive change in cervical dilation or effacement detected by serial examinations, when maternal participant is asymptomatic - Uncomplicated twin gestation. • Pregnant females at 24^0/7 to 36^0/7 weeks of gestation at the time of study intervention administration (Day 1), as established by: - Last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) (i.e. at or before 28 weeks of gestation). - first or second trimester U/S only, if LMP is unknown/uncertain. - Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable. The level of diagnostic certainty of the gestational age should be established by using the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) gestation age assessment tool • Participants who are willing to provide cord blood. • Willing to have their offspring followed-up after delivery for a period of 12 months. • Participants who do not plan to give their offspring for adoption or place the child 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 participants • Live-born from the study pregnancy. • If required per local regulations / guidelines, re-signed (confirmed) written or witnessed/thumb printed informed co
Exclusion criteria
Exclusion criteria: Maternal participants Medical conditions • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. • Hypersensitivity to latex. • Any pre-existing medical conditions or obstetric complications in the current pregnancy that, are poorly controlled and/or with clinical evidence of a non-reassuring fetal status and/or are likely to result in delivery within 7 days after study intervention administration and/or when the timing of planned delivery is within 7 days after study intervention administration and/or acute conditions requiring immediate medical attention for maternal stabilization and/or treatment. • A multiple pregnancy with 3 or more fetuses. • Complicated twin gestation. • Placenta Accreta Spectrum, including placenta increta, percreta, and accreta. • Fetal structural defects or genetic abnormalities that affect (or are likely to affect) fetal health or survival during the first year of life. • Known or suspected impairment of the immune system or immunodeficiency syndrome other than HIV. • Lymphoproliferative disorder or malignancy within 5 years before study dose administration. • Any illness of the mother or conditions of the fetus that, may substantially interfere with the maternal participant’s ability to comply with study procedures, or could increase the risks to the mother or the fetus, or could preclude the evaluation of the participant's data. • Any other clinical condition that, might pose additional risk to the participant due to participation in the study, as determined by medical history, physical examination or laboratory screening tests. • Women with any diagnosis, condition, treatment, or other factor that, has the potential to affect or confound assessments of immunogenicity or safety • Any conditions which, in the investigator’s opinion, would increase the risks of study participation to the unborn infant. Prior/Concomitant therapy • Prior receipt of an RSV maternal vaccine. • Use of any investigational or non-registered product other than the study intervention(s) during the period beginning: - For a drug, vaccine or medical device: 29 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period. - For immunoglobulins: 90 days before the dose of study intervention(s), or their planned use during the study period. The exception to this is investigational products administered in the setting of a pandemic. Administration in this case should respect the same period outlined above prior to study intervention administration, but may be allowed following delivery. • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 29 days before the study Day 1 and ending at delivery, with the exception of seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap – alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, all of which may be administered according to standard of care = 15 days before or after study intervention (Day 1). • Receipt of blood or plasma products or immunoglobulin, from 90 days before study intervention administration, or planned receipt through delivery, with the exception of Rho(D) immunoglobulin, which can be given at any time. • Administration of immune-modifying therapy within 6 months before study intervention administration, or planned administration through delivery, except if it is part of ma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Percentage of maternal participants reporting solicited administration site events 2. Percentage of maternal participants reporting solicited systemic events 3. Percentage of maternal participants reporting unsolicited adverse events (AEs) 4. Percentage of maternal participants reporting serious adverse events (SAEs), (S)AEs leading to study withdrawal, and medically attended adverse events (MAEs) 5. Percentage of maternal participants reporting pregnancy outcomes 6. Percentage of maternal participants reporting pregnancy-related adverse events of special interest (AESIs) 7. Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 up to 42 days post-delivery 8. Percentage of infant participants reporting neonatal / infant AESIs 9. Percentage of infant participants reporting SAEs, (S)AEs leading to study withdrawal, and MAEs 10. Humoral immune response in terms of RSV MAT immunoglobulin G (IgG)-specific antibody concentrations at pre-dosing (Day 1) for maternal participants 11. Humoral immune response in terms of RSV MAT IgG-specific antibody concentrations at delivery for maternal participants 12. Humoral immune response in terms of RSV-A neutralizing antibody titers at pre-dosing (Day 1) for maternal participants 13. Humoral immune response in terms of RSV-A neutralizing antibody titers at delivery for maternal participants 14. Geometric Mean Ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations. 15. Humoral immune response in terms of RSV MAT IgG-specific antibody concentrations at delivery for infant participants 16. Humoral immune response in terms of RSV-A neutralizing antibody titers at delivery for infant participants;Timepoint(s) of evaluation of this end point: 1, 2. From Day 1 to Day 7 included 3. From Day 1 to Day 30 included 4, 5, 6, 7. From Day 1 up to 42 days post-delivery 8, 9. From birth up to 42 days post-birth 10, 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of maternal participants reporting SAEs, (S)AEs leading to study withdrawal, and MAEs 2. Percentage of maternal participants reporting worsening of pre-existing medical conditions and/or obstetric complications from Day 1 post-dosing up to 180 days post-delivery 3. Percentage of maternal participants reporting RSV-associated medically attended respiratory tract illnesses (MA-RTIs) 4. Percentage of infant participants reporting SAEs, (S)AEs leading to study withdrawal, and MAEs from birth up to 180 days post-birth 5. Percentage of infant participants reporting SAEs, (S)AEs leading to study withdrawal, and MAEs from birth up to 365 days post-birth 6. Percentage of infant participants reporting medically assessed, RSV-associated LRTIs 7. Percentage of infant participants reporting medically assessed, RSV-associated hospitalizations 8. Humoral immune response in terms of RSV MAT IgG-specific antibody concentrations at Day 31 post-dosing for maternal participants 9. Humoral immune response in terms of RSV-A neutralizing antibody titers at Day 31 post-dosing for maternal participants 10. Humoral immune response in terms of RSV-B neutralizing antibody titers at pre-dosing (Day 1), Day 31 post-dosing and delivery for maternal participants 11. Humoral immune response in terms of RSV-B neutralizing antibody titers at delivery for infant participants 12. Humoral immune response in terms of RSV MAT IgG-specific antibody concentrations at Day 43, Day 121 and Day 181 post-birth for infant participants 13. Humoral immune response in terms of RSV-A neutralizing antibody titers at Day 43, Day 121 and Day 181 post-birth for infant participants 14. Humoral immune response in terms of RSV-B neutralizing antibody titers at Day 43, Day 121 and Day 181 post-birth for infant participants;Timepoint(s) of evaluation of this end point: 1, 3. From Day 1 up to 180 days post-delivery 2. From Day 1 post-dosing up to 180 days post-delivery 4. From birth up to | — |
Countries
Brazil, Canada, Finland, India, Italy, Panama, South Africa, Spain, United States
Contacts
Public ContactCENTRO DE INFORMACIÓN
GlaxoSmithKline S.A.
Outcome results
None listed