Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)
Brief Summary: There is a growing body of literature suggesting that monoclonal antibody could be efficacious in infants with RSV-bronchiolitis, well tolerated with no or clinically insignificant adverse effects.

"The investigators hypothesize that a single dose of iv palivizumab 15 mg/kg in diagnosed infants \<3 months old with RSV bronchiolitis will result in fewer infants with readmissions to infirmary/observation or hospital for relapse during 3 weeks of follow-up after discharge".


Options:
A: Inclusion Criteria:

* The child must have been born at less than or equal to 35 weeks gestation and be less than or equal to 6 months of age at the time of entry into the study (child must be entered on or before his/her 6-month birthday); or the child must be less than or equal to 24 months of age at the time of entry into the study (child must be entered on or before his/her 24-month birthday) and diagnosed with chronic lung disease (CLD) of prematurity with stable or decreasing doses of diuretics, steroids, or bronchodilators, or treatment with supplemental oxygen, within the previous 6 months.
* The child must be in general good health at the time of study entry.
* The child's parent(s)/legal guardian must provide written informed consent.
* The child must be able to complete the follow-up visits through 120-150 days from last injection of study drug.
* Parent(s)/legal guardian of patient must have available telephone access.

Exclusion Criteria:

* Hospitalized at the time of study entry (unless discharge is expected within 10 days after entry into the study)
* Receiving chronic oxygen therapy or mechanical ventilation at the time of study entry (including continuous positive airway pressure \[CPAP\])
* Congenital heart disease (CHD) (children with medically or surgically corrected \[closed\] patent ductus arteriosus and no other CHD may be enrolled)
* Evidence of infection with hepatitis A, B, or C virus
* Known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency or HIV infection (a child of a mother with known HIV infection must be proven to be uninfected at the time of enrollment)
* Suspected serious allergic or immune-mediated events with prior receipt of palivizumab
* Acute illness or progressive clinical disorder
* Active infection, including acute RSV infection, at the time of enrollment
* Previous reaction to intravenous immunoglobulin (IGIV), blood products, or other foreign proteins
* Received within the past 120 days or currently receiving immunoglobulin products (such as RSV-IGIV \[RespiGam\], IVIG, or palivizumab) or any investigational agents
* Previous participation in a clinical trial of motavizumab
* Currently participating in any investigational study
B: Inclusion Criteria:

* Infants ≤ 3 months-old, presenting to the main pediatric ER with acute bronchiolitis associated with positive RSV rapid antigen test.

Exclusion Criteria:

* Patients will be excluded from the study if they had 1 or more of the following characteristics:

  * Received monoclonal antibody or IVIG within the last 3 months prior to randomization.
  * Receipt of steroids within 2 days before randomization.
  * Hypersensitivity to monoclonal antibodies or immunoglobulin products.
  * Immunodeficiency.
  * Suspected sepsis.
  * Seizure disorders.
  * Neuromuscular disorders.
  * Congenital heart disease.
  * Major congenital anomalies of respiratory tract.
C: Inclusion Criteria:

Children must meet all of the following criteria:

* Previously healthy
* Age less or equal to 12 months at the time of randomization
* Gestational age more or equal to 36 weeks
* Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia)
* Documented positive RSV test within 48 hours prior to randomization
* Randomization within 12 hours of the decision to hospitalize a child for RSV illness
* Written informed consent obtained from the participant's parent(s)/legal guardian

Exclusion Criteria:

Children must have none of the following:

* Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
* Any use of systemic or inhaled steroids within the past 30 days prior to randomization
* Intubation for ventilatory support at randomization
* Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection
* Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
* Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed)
* Mechanical ventilation at any time prior to the onset of the current RSV infection
* Congenital heart disease \[children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\]
* Previous reaction to IVIG, blood products, or other foreign proteins
* Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months
* Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization
* Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
D: Inclusion Criteria - Maternal Participants:

* Healthy women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Receiving prenatal standard of care based on country requirements.
* Had a fetal anomaly ultrasound examination performed at ≥18 weeks of pregnancy with no significant fetal abnormalities observed.
* Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
* Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
* Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
* Expected to be available for the duration of the study and can be contacted by telephone during study participation.
* Participant is willing to give informed consent for her infant to participate in the study.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.

Inclusion Criteria -Infant Participants:

* Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
* Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

* Prepregnancy body mass index (BMI) of \>40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
* 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 (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
* Current pregnancy resulting from in vitro fertilization.
* Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

  * Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
  * Placental abnormality.
  * Polyhydramnios or oligohydramnios.
  * Significant bleeding or blood clotting disorder.
  * Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
  * Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
* Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the study, including but not limited to the following:

  * Prior preterm delivery ≤34 weeks' gestation.
  * Prior stillbirth or neonatal death.
  * Previous infant with a known genetic disorder or significant congenital anomaly.
* Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations).
* Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment.
* 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 consent and/or during study participation.
* Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for \>14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of \<20 mg/day for ≤14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids.
* Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
* Receipt of blood or plasma products or immunoglobulin (Ig), 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. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
* Participants who are breastfeeding at the time of enrollment.

Exclusion Criteria -Infant Participants:

o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Answer: B