Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phae 2 Efficacy Trial of AV Lotion for the Prevention of Cold Illness in Human Subjects
Brief Summary: The purpose of this of this study is to determine if 3804-250A can prevent the common cold caused by the rhinovirus when applied to the hands. The study will also evaluate whether 3804-250A can prevent rhinovirus infection or common cold illnesses.

The study will also evaluate the safety of 3804-250A.


Options:
A: Inclusion Criteria:

* Trainees assigned to one of the six selected training battalions
* Trainees who present with an SSTI at the clinic or the hospital
* Provide informed consent

Exclusion Criteria:

* Fails to meet inclusion criteria
B: Inclusion Criteria:

* Read and sign a copy of the approved Consent Form;
* 18-40 years of age;
* If a woman of child bearing potential (WOCBP) must have a negative urine pregnancy test and be using an effective method of birth control such as, but not limited to, birth control pills, contraceptive foam, diaphragm, IUD, vasectomized partner, abstinence, or condoms;
* Capable of compliance with the required study and sick visits (i.e., no planned travel commitments);
* Willing to follow study restrictions;
* Generally in good health based on medical history interview.

Exclusion Criteria:

* Current participation on any study;
* Participation in an investigational drug study within 30 days of enrollment;
* Participation within 30 days of enrollment on any study where the hands were the test site;
* Pregnancy (as determined by an urine pregnancy test), lactation or planning a pregnancy during the course of the study;
* Daily smoker;
* Current or significant history of sinusitis;
* Skin conditions on the hands or wrists that would interfere with the evaluations, such as scars, tattoos, uneven skin tones, or other conditions;
* Allergy to soaps, detergents, preservatives, citric acid, malic acid or ethanol;
* Immunological disorders (i.e., AIDS, HIV, systemic lupus erythematosis, rheumatoid arthritis);
* Current use or use within 7 days prior to randomization of any antibacterial medications for treatment of respiratory infections;
* Current use or use within 7 days enrollment of topical drugs (e.g. hydrocortisone or other corticosteroids) to treat skin conditions on the hands or wrists, except for localized treatment of minor cuts or scrapes;
* Occupational or other requirement for unusually frequent hand washing (i.e. health care worker, food service worker);
* Currently suffering from respiratory allergies or a history of seasonal respiratory allergies that are normally active during the study period;
* History of dermatologic disease on the hands, wrists or arms;
* History of 3rd degree burns and/or skin grafts on the hands or wrists;
* History of significant or frequent skin and soft tissue infections;
* Use of androgens, immunomodulators (such as growth factors, systemic corticosteroids, immune globulin, interleukins, interferons) or immunosuppressive medications within 30 days prior to study entry.
* Erythema score of 1.0 and/or dryness scores on the hands at enrollment of greater than Grade 0;
* Subject does not experience colds;
* The subjects from TM\&R-0062-08-TXC who were discontinued for irritation, experienced test product related skin reactions or were withdrawn from the study or excluded from the per-protocol analysis for non-compliance.
C: 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.
D: 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

Answer: B