Respiratory Syncytial Virus InfectionsNCT00111878
Study to Evaluate MEDI-534 in Healthy Adults
An observational study of Respiratory Syncytial Virus Infections and Parainfluenza Infections, run by MedImmune LLC at 3 sites in United States.
Trial summary
The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections, Parainfluenza Infections
- What is being tested?
- MEDI-534
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Dec 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female ages 18 through 40 years (not yet reached their 41st birthday) on the day of randomization
- Healthy by medical history and physical examination
- Available by telephone
- Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the volunteer
- Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to dosing of study vaccine, and must agree to continue using such precautions for at least 30 days after dosing; the volunteer must also have a negative serum pregnancy test within 7 days prior to dosing of study vaccine and a negative urine pregnancy test on the day of study vaccine dosing prior to administration
- Sexually active males, unless surgically sterile, must use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions for at least 30 days after dosing
- Ability 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
Who cannot join
- Acute illness on the day of randomization
- Fever (greater than or equal to 99.5°F oral or greater than or equal to 100.1°F tympanic) 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 (except for certain medications such as contraceptives, topical [i.e., dermatologic] corticosteroids, or infrequent use of over-the-counter pain relievers, following approval from the sponsor) or expected receipt through 28 days after study vaccine dosing
- Receipt of immunoglobulin or blood products within 90 days prior to screening or expected receipt through 28 days after study vaccine dosing
- Receipt of any investigational drug within 60 days prior to randomization or expected receipt during the study period (i.e., through 180 days after study vaccine dosing)
- Receipt of an approved vaccine within 30 days prior to randomization or expected receipt through 28 days after study vaccine dosing
Show all 22Show fewer
- History of immunodeficiency or receipt of immunosuppressive agents, or expected receipt of an immunosuppressive agent through 28 days after study vaccine dosing
- Close contact at home or in the workplace with children under 2 years of age
- Household contact who is immunocompromised; volunteer should also avoid close contact with immunocompromised individuals for at least 21 days after vaccination
- History of hypersensitivity to kanamycin or other aminoglycoside antibiotics (gentamicin, tobramycin, etc.)
- Previous medical history, or evidence, of an intercurrent or chronic illness that, in the opinion of the investigator, may compromise the safety of the volunteer
- Any evidence of end organ dysfunction
- Current, or history of, clinically significant abnormality on electrocardiogram (ECG) (screening ECG must be within 30 days prior to randomization)
- Evidence of active infection with HIV or hepatitis A, B, or C virus, or serologic evidence of past infection with hepatitis B or C virus
- At screening (must be within 7 days prior to randomization), any of the following laboratory tests outside of the laboratory normal range: CBC: hemoglobin (Hgb), WBC count, platelet count; AST, ALT, BUN, creatinine; or other abnormal laboratory value in the screening panel that, in the opinion of the principal investigator, may potentially confound analysis of study results
- Nursing mother
- History of alcohol or drug abuse in the past 2 years
- History of medical diagnosis of asthma, reactive airway disease, or chronic obstructive pulmonary disease (COPD)
- History of any smoking in the past 5 years
- Previous vaccination against Respiratory Syncytial Virus (RSV) or Parainfluenza Virus Type 3 (PIV3) in a clinical trial
- Employees of the research center, any individuals involved with the conduct of the study, or family members of such individuals
- Any condition that, in the opinion of the investigator, might interfere with study vaccine evaluation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital
Columbus, Ohio, 43205
Radiant Research
Dallas, Texas, 75247
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241
About this study
Official title: Dose-Escalating Study to Evaluate MEDI-534 in Healthy Adults
The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers.
- Being tested
- MEDI-534
- Keywords
- Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3)
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-534Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2005 (estimated)
- Study startApr 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Margarita Gomez, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111878
- Sponsor's protocol ID
- MI-CP119
- Status last verified
- Jul 2007
- First submitted
- 26 May 2005
- Last updated
- 3 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalating Study to Evaluate MEDI-534 in Healthy Adults
- ClinicalTrials.gov ID
- NCT00111878
- Acronym / sponsor ID
- MI-CP119
- Keywords
- Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Dec 2005
- First posted
- 27 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to describe the safety and tolerability of a single dose of MEDI-534 when administered to healthy adult volunteers.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female ages 18 through 40 years (not yet reached their 41st birthday) on the day of randomization
- Healthy by medical history and physical examination
- Available by telephone
- Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization obtained from the volunteer
- Sexually active females, unless surgically sterile or at least 1 year post-menopausal, must have used an effective method of avoiding pregnancy (including oral, implanted, or transdermal contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for at least 30 days prior to dosing of study vaccine, and must agree to continue using such precautions for at least 30 days after dosing; the volunteer must also have a negative serum pregnancy test within 7 days prior to dosing of study vaccine and a negative urine pregnancy test on the day of study vaccine dosing prior to administration
Key exclusion criteria (22 listed)
- Acute illness on the day of randomization
- Fever (greater than or equal to 99.5°F oral or greater than or equal to 100.1°F tympanic) 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 (except for certain medications such as contraceptives, topical [i.e., dermatologic] corticosteroids, or infrequent use of over-the-counter pain relievers, following approval from the sponsor) or expected receipt through 28 days after study vaccine dosing
- Receipt of immunoglobulin or blood products within 90 days prior to screening or expected receipt through 28 days after study vaccine dosing
- Receipt of any investigational drug within 60 days prior to randomization or expected receipt during the study period (i.e., through 180 days after study vaccine dosing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-534 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita Gomez, MD study director
MedImmune LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections and Parainfluenza Infections, run by MedImmune LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2007.