Please select the eligibility criteria that correspond to the clinical trial below.
Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Brief Summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


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 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.
B: Inclusion Criteria:

* influenza like illness symptoms
* positive rapid test for influenza
* inclusion within 48h of symptom onset
* inclusion of at least 3 members of a household (including index case)

Exclusion Criteria:

* severe illness
* other cases of similar symptoms within 14 days before onset of symptoms in index patient
* severe asthma or COPD
* pregnancy of index
C: Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.
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