Eligibility Details:
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.
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 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 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 (second degree cousins or closer)
- 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
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
