- Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of
planned vaccination, with an uncomplicated pregnancy, who are at no known increased
risk for complications, and whose fetus has no significant abnormalities observed on
ultrasound.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.
- Receiving prenatal standard of care.
- Had an ultrasound performed at >=18 weeks of pregnancy.
- Had a negative urinalysis for protein and glucose at the screening visit. Trace
protein in the urine is acceptable if the blood pressure is also normal.
- Determined by medical history, physical examination, screening laboratory assessment,
and clinical judgment to be appropriate for inclusion in the study.
- Documented negative human immunodeficiency virus antibody, hepatitis B virus surface
antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
- Body mass index of =40 kg/m2 at the time of the screening visit.
- Capable of giving signed informed consent, which includes compliance with the
requirements and restrictions listed in the informed consent document and in this
protocol.
- Expected to be available for the duration of the study and willing to give informed
consent for her infant to participate in the study.
Inclusion Criteria - Infant Participants:
- Evidence of a signed and dated ICD signed by the parent(s).
- Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory
tests, and other study procedures.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.
- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction to any component of the investigational product or any related vaccine.
- History of latex allergy.
- History of any severe allergic reaction.
- Participants with known or suspected immunodeficiency.
- Current pregnancy resulting from in vitro fertilization or other assisted reproductive
technology.
- A prior history of or known current pregnancy complications or abnormalities that will
increase the risk associated with the participant's participation in and completion of
the study.
- Major illness of the mother or conditions of the fetus that, in the investigator's
judgment, will substantially increase the risk associated with the participant's
participation in, and completion of, the study or could preclude the evaluation of the
participant's response.
- Participant with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention including but not limited to systemic or cutaneous
lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré
syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis),
psoriasis, and insulin-dependent diabetes mellitus (type 1).
- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.
- Participation in other studies involving investigational drug(s) within 28 days prior
to study entry and/or during study participation.
- Participants who receive treatment with immunosuppressive therapy including cytotoxic
agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or
planned receipt of such treatment or agents during study participation. If systemic
corticosteroids have been administered short term (
illness, participants should not be enrolled into the study until corticosteroid
therapy has been discontinued for at least 30 days before investigational product
administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or
eyes) corticosteroids are permitted.
- Current alcohol abuse or illicit drug use.
- Receipt of blood or plasma products or immunoglobulin, from 60 days before
investigational product administration, or planned receipt through delivery, with 1
exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
- Previous vaccination with any licensed or investigational RSV vaccine or planned
receipt during study participation.
- Laboratory test results at the screening visit outside the normal reference value for
pregnant women according to their trimester in pregnancy.
- Participants who are breastfeeding at the time of the screening visit.
Exclusion Criteria - Infant Participants:
? Infant who is a direct descendant (eg, child or grandchild) of the study personnel.