Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
Brief Summary: MI-CP117 was a Phase 3, randomized, double-blind, placebo-controlled trial designed to determine if motavizumab is more effective than placebo in reducing RSV hospitalization in otherwise healthy Native American Infants in the Southwestern United States during their first RSV season.


Options:
A: Inclusion Criteria:

* Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze, accessible to follow up, whose guardians give written informed consent.

Exclusion Criteria:

* Children with severe disease, received any documented antibiotic treatment in the past 48 hours, diagnosed asthmatic on maintenance therapy, complicating acute non-pulmonary or chronic illness, known drug allergy, hospitalization in the past 2 weeks, measles or history of measles within the last month, known immunodeficiency disorder, prior enrollment in the study, residing in areas not accessible for follow-up or whose guardian refuses to consent for the study. Radiological Pneumonia on X-Ray.
B: Inclusion Criteria:

* Infants born July \~ December 2007 at 33\~35 weeks of gestation

Exclusion Criteria:

* Intrauterine growth retardation (less than -2.5SD)
* Infants with chronic lung disease (CLD) or other respiratory disease
* Infants received mechanical ventilation.
* Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency).
* Infants received less than 3 doses of palivizumab during the first 6 months of life
C: Inclusion Criteria:

* History of cough or difficult breathing \< 14 days (observed or reported) AND
* Respiratory rate ≥ 50 breaths per minute in children 2 to \<12 months (on two consecutive readings by independent physicians) OR respiratory rate ≥ 40 breaths per minute in children12- 59 months (on two consecutive readings by independent physicians) AND
* Written informed consent by a legal guardian

Exclusion Criteria:

* Previously enrolled in study
* Pedal edema
* History of hospitalization in last two weeks
* With severe lower chest wall in-drawing
* Known asthmatics,TB or other severe illness
* Antibiotics taken in last 48 hours
* Bulging fontanel
* Congenital heart disease
* Any surgical condition requiring hospitalization
* Out of catchment area
* Any general danger sign as defined by WHO: Stridor when calm; hypoxia (SaO2 \< 90% in air) ; inability to feed; persistent vomiting (after three attempts to feed the baby within ½ hour); convulsions; reduced conscious level
D: Inclusion Criteria:

* 6 months of age or younger at randomization (child must be randomized on or before their 6-month birthday)
* Male or female Native American
* General state of good health
* Written informed consent obtained from the participant's parent(s) or legal guardian

Exclusion Criteria:

* Gestational age less than or equal to 35 weeks
* Chronic lung disease of prematurity
* A bleeding diathesis that would preclude IM injections
* Hospitalization at the time of randomization (unless discharge is anticipated within 10 days)
* Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection
* A documented wheezing episode before enrollment
* Known renal impairment
* Known hepatic dysfunction
* Clinically significant congenital anomaly of the respiratory tract
* Chronic seizure or evolving or unstable neurologic disorder
* Congenital heart disease (CHD) (children with uncomplicated CHD \[e.g., Patent ductus arteriosus, small septal defect\] and children with complicated CHD who are currently anatomically and hemodynamically)
* Known immunodeficiency
* Mother with human immunodeficiency virus infection (unless the child has been proven to be not infected)
* Known allergy to Ig products
* Receipt of palivizumab, Respiratory syncytial virus immunoglobulin, intravenous (RSV-IGIV), or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B immunoglobulin, IVIG) within 3 months prior to randomization
* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
* Previous receipt of RSV vaccines
* Participation in other investigational drug product studies
* Any medical or social condition which, in the opinion of the investigator, would adversely affect monitoring the infant
* Inability to complete the study follow-up period through up to 5 years of age

Answer: D