Please select the eligibility criteria that correspond to the clinical trial below.
Title: Incidence of Respiratory Illness in Outpatient Healthcare Workers Who Wear Respirators or Medical Masks While Caring for Patients
Brief Summary: Despite widespread use of respiratory protective equipment in the U.S. healthcare workplace, there is very little clinical evidence that respirators prevent healthcare personnel (HCP) from airborne infectious diseases. Scientific investigation of this issue has been quite complicated, primarily because the use of respirators has become "the standard of care" for protection against airborne diseases in some instances, even without sufficient evidence to support their use. The key question remains: How well do respirators prevent airborne infectious diseases? The answer to this important question has important medical, public health, political and economic implications.


Options:
A: 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 study 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 study vaccination, and
  * Has a negative pregnancy test on the day of study vaccination, and
  * Has agreed to continue adequate contraception during the 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.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after 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.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
* History of severe allergic reaction after a previous dose of any tetanus toxoid, diphtheria toxoid, or pertussis antigen-containing 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.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 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 within the 3 months prior to study vaccination, or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Family history of congenital or hereditary immunodeficiency.
* History of or current autoimmune disease.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
* Malignancy within previous 5 years or lymphoproliferative disorder.
* Current alcohol and/or drug abuse.
* Acute disease and/ or fever at the time of enrolment.
* Hypersensitivity to latex.
* 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 or findings.
B: 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.
C: Inclusion Criteria:

* Male or female aged 1 through 9 years old
* In general good health
* Seropositive for RSV (enzyme-linked immunosorbent assay \[ELISA\] titer \> 12 U/ml) and PIV3 (hemagglutination-inhibition \[HAI\] titer \> 1:8)
* Subject's parent/legal representative available by telephone
* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (if applicable) obtained from the subject's parent/legal representative
* Ability of the subject's parent/legal representative to understand and comply with the requirements of the protocol as judged by the investigator
* Ability to complete the follow-up period of 6 months following dosing as required by the protocol

Exclusion Criteria:

* Any fever and/or respiratory illness (e.g., cough or sore throat) within 7 days prior to randomization
* Any drug therapy (chronic or other) within 7 days prior to randomization or expected receipt of such therapy through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Any current or expected receipt of systemic immunosuppressive agents including steroids; children in this category should not receive study vaccine until immunosuppressive agents including corticosteroid therapy have been discontinued for less than or equal to 30 days
* Receipt of blood transfusion within 7 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of immunoglobulin products within 11 months prior to randomization or expected receipt through 35 days after study vaccine dosing
* Receipt of any investigational drug within 60 days prior to randomization or expected receipt through 180 days after study vaccine dosing
* Receipt of any other live virus vaccine within 30 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* Receipt of any inactivated (i.e., non-live) vaccine within 14 days prior to randomization or expected receipt through the protocol-specified blood collection 28-35 days after study vaccine dosing
* History of Guillain-Barré syndrome
* Known or suspected immunodeficiency, including HIV
* Known or suspected acute or chronic hepatitis infection
* Living at home or attending day care with children less than or equal to 24 months of age
* Contact with pregnant caregiver
* Household contact who is immunocompromised; the subject should also avoid close contact with immunocompromised individuals for at least 30 days after study vaccine dosing
* History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc)
* Previous medical history, or evidence, of chronic illness may compromise the safety of the subject
* At screening any of the following laboratory tests outside of the laboratory normal range: complete blood count (CBC) with differential and platelet count, AST, ALT, blood urea nitrogen (BUN), creatinine, or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, is considered to be clinically significant or may potentially compromise the safety of the subject during the conduct of the study
* History of medically confirmed diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
* Passive primary household smoking
* Family member or household contact who is an employee of the research center with the conduct of the study
* Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
D: Inclusion Criteria:

* Participant is at least 6 months (defined as at least 180 days) of age at the time of screening and less than 25 months (defined as less than 750 days) of age
* Participant is in good health based on review of the medical record, history, and physical examination, without evidence of chronic disease. Note: any questions regarding interpretation of this criterion should be forwarded to the team.
* Parents/guardians demonstrate their understanding of the study, sign the informed consent, and agree to administration of study product following a detailed explanation of the study
* Seronegative for RSV antibody, defined as a serum RSV-neutralizing antibody titer less than 1:40 at screening obtained no more than 42 days prior to scheduled inoculation
* Has a current height and weight above the 5th percentile for age
* Participant has received routine immunizations appropriate for age. Prior vaccines were administered at least:

  * 2 weeks prior to enrollment for inactivated and subunit vaccines and rotavirus vaccine, and
  * 4 weeks prior to enrollment for all other live vaccines.
* Participant is expected to be available for the duration of the study
* If born to an HIV-infected woman, participant must be non-breastfeeding with documentation of two negative HIV nucleic acid (RNA or DNA) tests with both collected when at least 1 month of age and at least one collected when at least 4 months of age, and no positive HIV nucleic acid (RNA or DNA) test; or two negative HIV antibody tests, both collected at less than or equal to 6 months of age

Exclusion Criteria:

* Known or suspected HIV infection or impairment of immunological functions
* Receipt of immunosuppressive therapy, including any systemic corticosteroids within 30 days of enrollment. Note: Cutaneous (topical) steroid treatment is not an exclusion.
* Bone marrow/solid organ transplant recipient
* Major congenital malformations (such as congenital cleft palate) or cytogenetic abnormalities
* Previous receipt of a licensed or investigational RSV vaccine (or placebo) or previous receipt of or planned administration of any anti-RSV product (such as ribavirin or RSV IG)
* Previous vaccine-associated anaphylactic or other severe adverse vaccine reaction
* Known hypersensitivity to any study product component
* Heart disease. Note: Participants with cardiac abnormalities documented to be clinically insignificant and requiring no treatment may be enrolled.
* Lung disease, including any history of wheezing or reactive airway disease
* Member of a household that contains, or will contain, an infant who is less than 6 months of age at the enrollment date through Day 28
* Member of a household that contains another child who is, or is scheduled to be, enrolled in IMPAACT 2000, and there has been or will be an overlap in residency during that other child's participation in the study's Acute Phase (Days 0 to 28)
* Member of a household that contains an immunocompromised individual, including, but not limited to:

  * a person who is greater than or equal to 5 years of age with HIV-related immunodeficiency, defined as having a most recent CD4 T lymphocyte cell count less than 300/mcL. CD4 T lymphocyte count must have been measured within 6 months prior to enrollment; or
  * a person less than 5 years of age with HIV-related immunodeficiency, defined as having a most recent CD4 T lymphocyte cell percentage less than 15. CD4 T lymphocyte percentage must have been measured within the 6 months prior to enrollment; or
  * a person who has received chemotherapy within the 12 months prior to enrollment.
  * Verbal report of CD4 T cell lymphocyte is sufficient documentation if the parent/guardian is confident of history.
* Attends a daycare facility and shares a room with infants less than 6 months of age, and parent/guardian is unable or unwilling to suspend daycare for 28 days following inoculation.
* Any of the following events at the time of enrollment:

  * fever (rectal temperature of greater than or equal to 100.4°F \[38°C\]), or
  * upper respiratory signs or symptoms (rhinorrhea, cough, or pharyngitis), or
  * nasal congestion significant enough to interfere with successful inoculation, or
  * otitis media.
* Receipt of the following prior to enrollment:

  * any killed vaccine or live-attenuated rotavirus vaccine within the 14 days prior, or
  * any live vaccine, other than rotavirus vaccine, within the 28 days prior, or
  * another investigational vaccine or investigational drug within 28 days prior.
* Scheduled administration of the following after planned inoculation:

  * killed vaccine within the 14 days after, or
  * any live vaccine other than rotavirus in the 28 days after, or
  * another investigational vaccine or drug in the 28 days after.
* Receipt of immunoglobulin, any antibody products, or any blood products
* Receipt of any of the following medications within 3 days of study enrollment:

  * systemic antibacterial, antiviral, antifungal, antiparasitic, or antituberculous agents, whether for treatment or prophylaxis, or
  * intranasal medications, or
  * other prescription medication except as listed below. Permitted concomitant medications (prescription or non-prescription) include nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including (but not limited to) cutaneous (topical) steroids, topical antibiotics, and topical antifungal agents.
* Receipt of salicylate (aspirin) or salicylate-containing products within the past month
* Born at less than 37 weeks gestation and less than 1 year of age at the time of enrollment
* Meets criteria for failure to thrive within the 6 months prior to enrollment: a decline in height or weight growth that has crossed two major growth percentiles (e.g., from above the 75th to below the 25th) in an interval of less than 6 months
* Suspected or documented developmental disorder, delay, or other developmental problem

Answer: B