Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults
Brief Summary: This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.


Options:
A: Inclusion Criteria:

* Volunteers working in defined units

Exclusion Criteria:

* Persons with open wounds or chronic eczema in hands
B: Inclusion Criteria:

* Age ≥ 60 years at the time of screening.
* Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the subject appears likely to be able to remain in follow-up through the end of protocol-specified follow-up.
* (Season 2): Subject received MEDI7510 and IIV in the Northern Hemisphere in Season 1.

Exclusion Criteria:

* History of allergy to any component of the vaccine.
* Receipt of seasonal influenza vaccine within 6 months prior to Season 1 dosing.
* History of allergy to or intolerance of IIV.
* Pregnancy or potential to become pregnant during the study. Females who (1) have had a menstrual period within the 12 months prior to study enrollment or (2) are undergoing any fertility treatment or who plan to undergo fertility treatments during the study period are excluded.
* History of Guillain-Barré syndrome.
* Previous vaccination against RSV.
* History of allergy to eggs in adulthood.
* History of or current autoimmune disorder, with the exception of stable, treated hypothyroidism caused by autoimmune thyroiditis, which is acceptable.
* Immunosuppression caused by disease, including human immunodeficiency virus infection (assessed by history), or medications. Any receipt of oral or intravenous glucocorticoid therapy within 30 days prior to enrollment or planned dosing within the follow-up period would disqualify. Topical, intranasal, inhaled, or intra-articular corticosteroids do not disqualify. Expected need for immunosuppressive medications during the follow-up period would disqualify.
* History of cancer within preceding 5 years other than treated non-melanoma skin cancer, locally-treated cervical cancer or in situ carcinoma of the breast.
* Receipt of any non-study vaccine within 28 days prior to study dosing or expected receipt of non-study vaccine prior to the Day 29 visit in Season 1.
* Receipt of any investigational product (IP) in the 90 days prior to randomization or expected receipt of IP 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 immunoglobulins or blood products 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).
* History of alcohol or drug abuse or psychiatric disorder that, in the opinion of the investigator, would affect the subject's safety or compliance with study.
* (Season 2): Related Grade 3 or 4 adverse event (AE) including Grade 3 or 4 local reaction to either MEDI7510 or IIV, any adverse event of special interest (AESI) for an adjuvanted vaccine, or any related serious adverse event (SAE).
C: Adult Inclusion Criteria:

* In good health
* Available for the duration of the trial
* Available for post-inoculation telephone contact
* For females, must agree to use effective birth control methods for the duration of the study

Seropositive Children Inclusion Criteria:

* In good health
* Seropositive for HPIV1
* Available for the duration of the study

Seronegative Infants and Children Inclusion Criteria:

* In good health
* Seronegative for HPIV1 antibody
* Available for the duration of the study

Adult Exclusion Criteria:

* Neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
* Condition, in the opinion of the investigator, that will not allow the participant to comply with the protocol
* Alcohol or drug abuse
* History of anaphylaxis
* History of splenectomy
* Diagnosis of asthma within 2 years of study entry
* HIV-infected
* Hepatitis C infection
* Hepatitis B infection
* Abnormal urinalysis
* Known immunodeficiency syndrome
* Current use of nasal or systemic steroid medications
* Receipt of blood products within 3 months of study entry
* Current smoker unwilling to stop smoking for the duration of the study. The decision to exclude a potential subject is made by the investigator based upon the potential subject's medical history and physical examination.
* Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine
* Receipt of live vaccine within 4 weeks or a killed vaccine within 2 weeks or immune globin within 3 months prior to receiving the investigational vaccine
* Previous immunization with an HPIV1 vaccine
* Known hypersensitivity to any vaccine component
* Participants whose profession and/or personal responsibilities involve caring for children less than 6 months of age or for immunosuppressed individuals
* Persistent systolic blood pressure more than 140 mm Hg or diastolic pressure more than 90 mm Hg
* Body mass index (BMI) more than 35
* Pregnant or breastfeeding

Seropositive and Seronegative Infants and Children Exclusion Criteria:

* Known or suspected impairment of immunological functions as determined by the investigator
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previous immunization with HPIV1 vaccine
* Current use of nasal or systemic steroid medications
* Previous serious vaccine-associated adverse event or anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including reactive airway disease as determined by the investigator
* Member of household that includes an immunocompromised individual or infant less than 6 months of age
* Attends day care with infants less than 6 months of age or immunosuppressed individuals. More information about this criterion can be found in the protocol.
* Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine or while study is occurring
D: 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.

Answer: B