Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)
Brief Summary: The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (\>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children \< 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:

* The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
* The risk factors for secondary transmission of influenza from an index case-patient to household contacts
* The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
* The impact of handwashing promotion on handwashing behavior six months after intervention
* The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza


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:

* Age greater than or equal to 60 years
* Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound)
* Weight greater than 90 lbs
* Hemoglobin greater than or equal to 10.5 g/dL for women and greater than or equal to 11 g/dL for men
* Subject able to complete follow-up period of 360 days after dosing

Exclusion Criteria:

* History of allergy to: any component of the vaccine; IIV or intolerance of IIV; eggs in adulthood
* Receipt of seasonal flu shot within 60 days prior to dosing
* Any unstable acute or chronic medical condition, including one that has resulted in change in therapy (medication or other) in the 30 days prior to randomization or hospitalization in the previous year or might be predicted to result in hospitalization in the year after enrollment. Subjects with severe, untreated or uncontrolled underlying medical disease that might either compromise subject safety or affect the ability to assess safety of the investigational product are excluded. Medications taken on an as-needed basis are permitted to start or stop during the 30 days prior to randomization unless they are medications not previously taken by the subject
* Clinically significant abnormalities in screening laboratory assessments or screening ECG
* History of hepatitis B or hepatitis C infection
* History of Guillain-Barré syndrome
* Cognitive disorder such that informed consent cannot be obtained directly from the subject
* Previous vaccination against RSV
* History of or current autoimmune disorder
* Immunosuppression caused by disease, including human immunodeficiency virus (HIV) infection, or medications. Any oral prednisone dosing within 30 days of enrollment or planned dosing within the 360-day follow-up period would disqualify. Expected need for immunosuppressive medications during the 360-day follow-up period would disqualify
* History of splenectomy or of condition affecting splenic function (eg, hemoglobinopathy)
* History of cancer within preceding 5 years other than treated non-melanoma skin cancer
* Body Mass Index 40 or higher
* Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected receipt of nonstudy vaccine within 30 days after study dosing
* Receipt of any investigational product in the 90 days prior to randomization or expected receipt of investigational product during the period of study follow-up
* Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of investigational product during the period of study follow-up
* Current bleeding or clotting disorder including use of anticoagulants other than drugs with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel, ticagrelor or aspirin)
* Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 72 hours after receipt of IP (Note: A daily dose of aspirin is not considered a contraindication to enrollment.)
* Subjects who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid region of both arms that, in the investigators opinion, could interfere with evaluation of injection site local reactions
* Concurrent enrollment in another clinical study that involves any invasive clinical procedure, including phlebotomy
* History of alcohol or drug abuse or psychiatric disorder that, in the investigators opinion, would affect the subject's safety or compliance with study
* Employees of individuals directly involved with the conduct of the study, individuals who themselves are involved with the conduct of the study, or immediate family members of such individuals
C: Inclusion Criteria:

* Clinical site leadership has agreed to have one or more staff participate in the trial
* Subject meets the definition of "healthcare personnel"
* Subject able to read and sign informed consent
* Subject agrees to all requirements of the protocol, including fit testing and diary keeping
* Subject's age is 18 or greater
* Subject passes fit testing for one of the study supplied respirator models and agrees to use that model for the entire intervention period of the study (if in respirator arm).

Exclusion Criteria:

* Subject self-identified as having severe heart, lung, neurological or other systemic disease that one or more Investigator believes could preclude safe participation
* Known to not tolerate wearing respiratory protective equipment for any period
* Facial hair, or other issue such as facial adornments, precluding respirator OSHA-compliant fit testing or proper mask fit during the study period
* Advised by Occupational Health (or other qualified clinician) to not wear the same or similar respirator or medical mask models used in this study
* In the opinion of the Investigator, may not be able to reasonably participate in the trial for any reason
* Self-identified as in, or will be in the third trimester of pregnancy, during the study period.
* Subject rotating in 2 different ResPECT study clinic sites /clusters during the 12-week study period.
* Subject works less than 75% of the intervention period in that clinic.
* Subject is a previous participant of the ResPECT Study, but does not consent for data from previous flu season(s) to be linked.
D: Inclusion Criteria:

1. ≥18 and ≤40 years-of-age
2. Singleton pregnancy of 28 to 36 0/7 weeks gestation on the day of planned vaccination

   * Documentation of gestational age will be based on one of the following composite criteria. (Note: The Investigator should use the earliest ultrasound data available to establish the study-specific gestational age dating):

     1. Gestational Age Dating Based on First Trimester Data (data obtained ≤13 6/7 weeks): The date of the first day of the reported last menstrual period (LMP) may be used to estable the gestational age if corroborated by a first trimester ultrasound. If the gestational age estimation derived using the LMP and the first trimester ultrasound are discrepant \>7 days, the ultrasound will be used to establish gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy.
     2. Gestational Age Dating Based on Early Second Trimester Data (data obtained 14 0/7 to 21 6/7 weeks): The day of the first reported LMP may be used to establish the gestational age if corroborated by an early second trimester ultrasound (that estimates the gestational age between 14 0/7 and 21 6/7 weeks). If the gestational age estimation derived using the LMP and the early second trimester ultrasound are discrepant \>10 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy.
     3. Gestation Age Dating Based on Later Second Trimester Data (data obtained 22 0/7 and 27 6/7 weeks by LMP): The date of the first day of the reported LMP may be used to establish the gestation age if corroborated by a later second trimester ultrasound (that estimates the gestational age between 22 0/7 and 27 6/7 weeks). If the gestational age estimation derived using the LMP and the later second trimester ultrasound are discrepant \>14 days, the ultrasound will be used to establish the gestational age. If LMP is uncertain or unknown, the ultrasound-established gestational age estimation will be used to establish the gestational age of the pregnancy.
     4. Gestational Age Dating When the LMP is Uncertain or Unknown AND No Prior First or Second Trimester Ultrasound Has Been Performed: An ultrasound performed at screening within the second trimester (≤27 6/7 weeks) will be used to establish the gestational age of the pregnancy.
3. Documentation of a second or third (between 18 0/7 weeks and prior to randomization) trimester ultrasound with no major fetal anomalies identified.
4. Good general maternal health as demonstrated by:

   * Medical history (including history of adverse reactions to prior vaccines and allergies).
   * Physical examination including at least vital signs (blood pressure, pulse, respirations, and oral temperature); weight; height; examination of the HEENT, cardiovascular, pulmonary, gastrointestinal (abdominal), musculoskeletal, lymphatic, and dermatologic organ systems; and documentation of fetal heart tones. Note that abnormal vital signs may be repeated at the investigator's discretion since these measures may be labile. Vital signs should be assessed in the context of normal values for the third trimester of pregnancy (see the Study Operations Manual).
   * Clinical laboratory parameters that include:

     * For the first year of study conduct in any country, normal/clinically insignificant blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase (ALP), hemoglobin, white blood count, and platelet count. Note that normal ranges for clinical laboratory parameters will be based on reference ranges appropriate for the subject population under study (i.e., third trimester of pregnancy) and as defined in the toxicity grading scale (TGS) (see the Study Operations Manual).
     * For all subjects, serologic exclusion of infection with hepatitis B (HBV) and C (HCV) viruses, syphilis, and HIV as documented by testing (performed at the central or local laboratory) at screening or by medical records during the current pregnancy.
5. Able to understand, and both willing and physically able to comply with study procedures. This includes anticipation of reasonable geographic proximity to the study clinic and adequate transportation to comply with scheduled and unscheduled study follow-up visits.
6. Able and willing to provide written informed consent for themselves and infant.

Exclusion Criteria:

1. Symptomatic cardiac or pulmonary disease requiring chronic drug therapy, including hypertension and asthma. Asthma will be exclusionary if the subject is receiving chronic systemic glucocorticoids at any dose or inhaled glucocorticoids at any dose \>500µg per day of beclomethasone or fluticasone, or \>800μg per day of budesonide.
2. Pregnancy complications (in the current pregnancy) such as preterm labor, hypertension (blood pressure \[BP\] \>140/90 in the presence of proteinuria or BP \>150/100 with or without proteinuria) or currently on an antihypertensive therapy or pre-eclampsia; or evidence of intrauterine growth restriction.
3. Grade 2 or higher clinical laboratory or vital sign abnormality. Exclusion of subjects with grade 1 abnormalities will be based on the subject's prior medical history and the investigator's clinical judgment that the abnormality is indicative of a meaningful physiologic event.
4. Receipt of any licensed vaccine (e.g., Tdap, inactivated influenza vaccine) within 14 days of study vaccination.
5. Received any RSV vaccine at any time.
6. Body mass index (BMI) of ≥40, at the time of the screening visit.
7. Hemoglobinopathy (even if asymptomatic) or blood dyscrasias.
8. Hepatic or renal dysfunction.
9. Established diagnosis of seizure disorder, regardless of therapy.
10. Known, active auto-immune disease or immunodeficiency syndrome.
11. Endocrine disorders, including (but not limited to) untreated hyperthyroidism, untreated hypothyroidism (unless due to auto-immune disease), and glucose intolerance (e.g., diabetes mellitus type 1 or 2) antedating pregnancy, or occurring during pregnancy and requiring interventions other than diet for control.
12. History of major gynecologic or major abdominal surgery, including bariatric surgery (previous Caesarean section is not an exclusion).
13. Known HIV, syphilis, HBV, or HCV infection, as assessed by serologic tests conducted during the current pregnancy or as a procedure during the screening period of the study.
14. Primary genital Herpes simplex virus (HSV) infection during the current pregnancy.
15. Current alcohol or drug abuse based on the Investigator's knowledge of present or recent (within the last 2 years) use/abuse of alcohol or illegal or non-prescription drugs.
16. Documentation that the current pregnancy results from in vitro fertilization (IVF).
17. Documentation that the current pregnancy results from rape or incest.
18. Documentation that the infant will be a ward of the state or be released for adoption.
19. History/presence of deep venous thrombosis or thromboembolism, or the use of anticoagulants during pregnancy (the use of low-dose aspirin as prophylaxis \[e.g., for the prevention of morbidity and mortality from preeclampsia\] is acceptable is dosages consistent with local standards of care).
20. Red blood cell allo-immunization.
21. Prior stillbirth or neonatal death, or multiple (≥3) spontaneous abortions.
22. Prior preterm delivery ≤34 weeks gestation or having ongoing intervention (medical/surgical) in current pregnancy to prevent preterm birth.
23. Greater than five (5) prior deliveries.
24. Previous infant with a known genetic disorder or major congenital anomaly.
25. Receipt of investigational drugs or immune globulins (with the exception of prophylactic anti-Rho D immune globulin) within six (6) months prior to the administration of the study vaccine.
26. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted except for the limit established in exclusion criterion #1.
27. Neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting, or receipt of pre-natal care; or requiring treatment with psychotropic drugs (excluding treatment for depression and anxiety).
28. Any other physical, psychiatric or social condition which may, in the investigator's opinion, increase the risks of study participation to the maternal subject or the fetus/infant; or may lead to the collection of incomplete or inaccurate safety data.
29. Acute disease within 72 hours of the day of the planned vaccination (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C).
30. History of a serious adverse reactions (e.g., anaphylaxis) to any prior vaccine.

Answer: A