Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV cps2, Lot RSV#005A, Delivered as Nose Drops to RSV-Seronegative Infants and Children 6 to 24 Months of Age
Brief Summary: Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children. This study will evaluate the safety and immune response to an RSV vaccine in healthy RSV-naïve children.


Options:
A: Inclusion Criteria:

* Persons ≥ 5 years old: Influenza-like illness (ILI), defined as history of fever and either cough or sore throat with fever onset within the previous 24 hours
* Persons \< 5 years old: any child with acute fever with onset within the previous 24 hours
* Return to home within 24 hours of presentation to Upazilla Health Complex, Jahurul Islam Medical College Hospital or the local pharmacies; i.e., the index case cannot be admitted for treatment. If admitted, the patient would not be eligible.
* No fever in any bari resident during the 7 days preceding the patient's presentation to hospital (see definition below)
* At least two persons (in addition to the index case-patient) who intend to reside in the bari during the subsequent 20 days
* Residence within 30 minutes travel time (one-way) from the Upazilla Health Complex or Jahurul Islam Medical College Hospital or the local pharmacy.
B: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject prior to performing any study specific procedure.
* Non-pregnant female between, and including, 18 and 45 years of age at the time of vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination and
  * has agreed to continue adequate contraception during the entire study period.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days prior to study vaccination, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
* Chronic administration of immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration during the study period. Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination.
* Previous experimental vaccination against RSV.
* Family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of or current auto-immune disease.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination and/or Medical History.
* Lymphoproliferative disorder or malignancy within previous 5 years.
* History of hypersensitivity after a previous dose of any tetanus, diphtheria, or pertussis vaccine or to any component of Boostrix.
* History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with pertussis-containing vaccine.
* History of any neurological disorders or seizures.
* History of transient thrombocytopenia or neurological complications following a previous vaccination against diphtheria and/or tetanus.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* Hypersensitivity to latex.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Current chronic alcohol consumption and/or drug abuse.
* Acute disease and/or fever at the time of enrolment.
* Body mass index (BMI) \> 40 kg/m2.
* Pregnant or lactating female.
* Planned move to a location that will prohibit participating in the trial until study end.
* Any other condition that the investigator judges may interfere with study procedures.
C: Inclusion Criteria:

* At least 6 months to less than 25 months of age at the time of enrollment
* Parents/guardians who demonstrate their understanding of the study (by taking the comprehension assessment), sign the informed consent, and agree to vaccine administration following detailed explanation of the study
* Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined within 42 days prior to enrollment
* Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health
* In the view of the site investigator, the participant has received routine immunizations appropriate for their age
* Participant is expected to be available for the duration of the study

Exclusion Criteria:

* Known or suspected impairment of immunological functions, including maternal history of positive HIV test
* Receipt of immunosuppressive therapy including systemic corticosteroids within 30 days of study entry. NOTE: Topical steroids, topical antibiotic, and topical antifungal medications are acceptable within 24 hours of enrollment. May be reassessed after symptoms have resolved.
* Bone marrow/solid organ transplant recipients
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previous immunization with an RSV vaccine or previous receipt of or planned administration of any anti-RSV antibody product
* Previous serious vaccine-associated AE or any anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including any wheezing event or reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
* Member of a household that includes an immunocompromised individual or infants less than 6 months of age
* Attends day care with infants less than 6 months of age, and whose parent/guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
* Fever (rectal temperature of greater than or equal to 100.4°F \[38°C\]), or upper respiratory illness (rhinorrhea, cough, or pharyngitis) or nasal congestion (that is significant enough to interfere with successful vaccination), or otitis media
* Has received any killed vaccine or live attenuated rotavirus vaccine within the last 2 weeks, any other live vaccine within the last 4 weeks, or gamma globulin (or other antibody products) within the past 3 months or is scheduled to receive any immunization in the 28 days after enrollment
* Receipt of another investigational vaccine or investigational drug within 28 days of receiving this investigational RSV vaccine
* Has received antibiotics or systemic or nasal steroid therapy or other prescription medications for acute illness within 3 days of study entry. Permitted concomitant medications include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) topical steroids, topical antibiotics, and topical antifungal agents.
* Has received salicylate (aspirin) or salicylate-containing products within the past month
* Infants born at less than 37 weeks gestation and less than 1 year of age
D: Inclusion Criteria:

* Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, is willing to be isolated and stay in the clinic for the quarantine phase, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
* Participants must be in good health, without significant medical illness, on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and weight), skin examination, medical history, vital signs (systolic and diastolic blood pressure and heart rate, respiratory rate, and body temperature), and the results of clinical laboratory tests performed within 56 days of vaccination. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participants must have a non-clinically significant 12-lead electrocardiogram (ECG) within 56 days of vaccination including: normal sinus rhythm (heart rate between 50 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) interval less than or equal to (\<=) 450 millisecond (ms); QT interval corrected for heart rate according to Bazett (QTcB) interval \<= 450 ms; QRS interval less than (\<) 120 ms; PR interval \<= 210 ms
* Participants must be sero-suitable for respiratory syncytial virus (RSV) within 90 days of vaccination (low immunity to the RSV-A Memphis 37b virus using a virus neutralization assay
* Participant must be healthy on the basis of clinical laboratory tests performed within 56 days of vaccination. If the results of the laboratory screening tests are outside the local laboratory normal reference ranges and additionally within the limits of toxicity Grade 1 according to the US Food and Drug Administration (FDA) toxicity tables (that is, for tests in the FDA table), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

Exclusion Criteria:

* Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (\>=) 37.8 degree Centigrade within 24 hours prior to study vaccination
* Participant has history of malignancy (exceptions are basal cell carcinomas of the skin treated over 5 years prior to vaccination considered cured with minimal risk of recurrence)
* Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively

Viral Challenge Exclusion Criteria:

* Participants having donated or lost more than 1 unit of blood (470 milliliter \[mL\]) within 60 days or more than one unit of plasma within 7 days
* Participants with active acute respiratory infection

Answer: C