Healthy Volunteers (prevention of lower respiratory tract illness)
Conditions
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion 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 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 pro
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and reactogenicity of a single IM dose of study vaccine administered to maternal subjects, from Visit 1 up to 6 weeks after delivery To evaluate pregnancy outcomes and pregnancy-related AESIs after a single IM dose of study vaccine administered to maternal subjects, from Visit 1 up to 6 weeks after delivery (Visit 6) To evaluate the safety of the study vaccine, including neonatal AEs of special interest, in infants born to maternal subjects who were vaccinated with a single IM dose of study vaccine, up to 6 weeks after birth To evaluate the immunogenicity of a single IM dose of study vaccine in maternal subjects at Day 31 and at Delivery To evaluate RSV-specific antibody levels at birth, in infants born to maternal subjects who were vaccinated with a single IM dose of study vaccine To evaluate the transfer of RSV-specific antibodies from maternal subjects vaccinated with a single IM dose of study vaccine to their infants at delivery/birth;Secondary Objective: To evaluate safety of: ? a single IM dose of study vaccine in maternal subjects, up to 6 months after delivery and in infants (born to vaccinated mothers), up to 1 year of age. To estimate the incidence of: ? RSV-associated, medically attended RTIs in maternal subjects vaccinated with a single IM dose of study vaccine, from vaccination up to 6 months post-delivery ? RSV-associated lower respiratory tract illness (LRTI), severe LRTI, very severe LRTI and hospitalization in infants from birth up to 6 months of age. To evaluate the immunogenicity of: ? single IM dose of study vaccine in maternal subjects in terms of RSVPreF3 IgG-specific antibody concentrations and neutralizing antibodies against RSV-A at Day 43 after delivery ? single IM dose of study vaccine in maternal subjects in terms of RSV-B neutralizing antibodies at Day 1 before vaccination, Day 31, at delivery and at Day 43 post-delivery. ? To evaluate RSV-specific antibodies in infants up to 6 months after bi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of maternal subjects with at least one SAE 2. Percentage of maternal subjects with at least one MAE 3. Percentage of maternal subjects with at least one AE leading to study withdrawal 4. Percentage of infant subjects with at least one SAE from birth through 6 months after birth 5. Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 6 months after birth 6. Percentage of infant subjects with at least one MAE from birth through 6 months after birth 7. Percentage of infant subjects with at least one SAE from birth through 1 year after birth 8. Percentage of infant subjects with at least one AE leading to study withdrawal from birth through 1 year after birth 9. Percentage of infant subjects with at least one MAE from birth through 1 year after birth 10. Percentage of maternal subjects with at least one RSV-associated Medically Attended RSV-associated Respiratory Tract Illnesses (MA-RTI) 11. Percentage of infant subjects with at least one RSV-associated LRTI 12. Percentage of infant subjects with at least one RSV-associated severe LRTI 13. Percentage of infant subjects with at least one RSV-associated very severe LRTI 14. Percentage of infant subjects with at least one RSV-associated hospitalisation 15. RSVPreF3 IgG antibody GMCs in maternal subjects, at day 43 16. RSV-A neutralizing antibody GMTs in maternal subjects, at day 43 17. RSV-B neutralizing antibody GMTs in maternal subjects at Day 1 18. RSV-B neutralizing antibody GMTs in maternal subjects at Day 31 19. RSV-B neutralizing antibody GMTs in maternal subjects at delivery 20. RSV-B neutralizing antibody GMTs in maternal subjects at Day 43 post-delivery 21. RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 43 after birth 22. RSVPreF3 IgG antibody GMCs in infants born to maternal subjects, at Day 121 after birth 23. RSVPreF3 IgG antibody concentration at Day 181 after birth 24. RSV-A | — |
Countries
Australia, Canada, Finland, France, New Zealand, Panama, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed